🧬 Biotechnology

Genetic engineering, synthetic biology, CRISPR, bio-manufacturing, lab-on-a-chip

Early Genomic Indicators of Praziquantel Resistance in Schistosoma mansoni

Schistosomiasis affects more than 250 million people worldwide, with 90% of infections occurring in sub‑Saharan Africa. The post Early Genomic Indicators of Praziquantel Resistance in <i>Schistosoma mansoni</i> appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Early Genomic Indicators of Praziquantel Resistance in Schistosoma mansoni. Schistosomiasis affects more than 250 million people worldwide, with 90% of infections occurring in sub‑Saharan Africa. The post Early Genomic Indicators of Praziquantel Resistance in <i>Schistosoma mansoni</i> appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Early Genomic Indicators of Praziquantel Resistance in <i>Schistosoma mansoni</i> appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Flu Virus Interaction with Host Cell Machinery Mapped Inside Infected Cells

Researchers developed a customized experimental workflow combining cross-linking mass spectrometry with AlphaFold-based structural modeling and functional assays to directly map protein-protein interactions in influenza-infected human cells. The post Flu Virus Interaction with Host Cell Machinery Mapped Inside Infected Cells appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Flu Virus Interaction with Host Cell Machinery Mapped Inside Infected Cells. Researchers developed a customized experimental workflow combining cross-linking mass spectrometry with AlphaFold-based structural modeling and functional assays to directly map protein-protein interactions in influenza-infected human cells.
TL;DR: The post Flu Virus Interaction with Host Cell Machinery Mapped Inside Infected Cells appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Protein Protects Against Tau Tangles, Synaptic Loss in Mouse Model of Tauopathy

Scientists found that upregulating a protein known as SORLA offers protection against the effects of tau tangles in a mouse model, pointing to a potential therapeutic strategy for tauopathies including Alzheimer’s disease. The post Protein Protects Against Tau Tangles, Synaptic Loss in Mouse Model of Tauopathy appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Protein Protects Against Tau Tangles, Synaptic Loss in Mouse Model of Tauopathy. Scientists found that upregulating a protein known as SORLA offers protection against the effects of tau tangles in a mouse model, pointing to a potential therapeutic strategy for tauopathies including Alzheimer’s disease.
TL;DR: The post Protein Protects Against Tau Tangles, Synaptic Loss in Mouse Model of Tauopathy appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Patient-Derived Tumor Organoids Show Promise for Personalizing Cancer Treatment

Researchers developed a 220-sample pan-cancer patient-derived organoid platform that faithfully mirrors tumors, identifies new treatment opportunities, and advances precision oncology by enabling personalized drug testing. The post Patient-Derived Tumor Organoids Show Promise for Personalizing Cancer Treatment appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Patient-Derived Tumor Organoids Show Promise for Personalizing Cancer Treatment. Researchers developed a 220-sample pan-cancer patient-derived organoid platform that faithfully mirrors tumors, identifies new treatment opportunities, and advances precision oncology by enabling personalized drug testing.
TL;DR: The post Patient-Derived Tumor Organoids Show Promise for Personalizing Cancer Treatment appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Memory Shaped by Brain Remodeling During Adolescence in Mice

Protective mesh-like structures, called perineuronal nets, stabilize memory circuits and unexpectedly diminish during late adolescence before rebuilding in adulthood. The post Memory Shaped by Brain Remodeling During Adolescence in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Memory Shaped by Brain Remodeling During Adolescence in Mice. Protective mesh-like structures, called perineuronal nets, stabilize memory circuits and unexpectedly diminish during late adolescence before rebuilding in adulthood. The post Memory Shaped by Brain Remodeling During Adolescence in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Memory Shaped by Brain Remodeling During Adolescence in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

UnitedHealth Group lays out progress in AI push

After announcing a hefty investment in AI earlier this year, UnitedHealth laid out how it's using the technology across its business in a quarter that landed better than expected. The health insurer, which has dealt ...

More: After announcing a hefty investment in AI earlier this year, UnitedHealth laid out how it's using the technology across its business in a quarter that landed better than expected. The health insurer, which has dealt ...
TL;DR: After announcing a hefty investment in AI earlier this year, UnitedHealth laid out how it's using the technology across its business in a quarter that landed better than expected.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

House lawmakers back trade probe of China biotech, sequencing

At least 10 House lawmakers are backing a US trade panel’s probe of China’s biotech sector and related pricing practices, encouraging future executive action. In a letter sent to Secretary of the US International Trade ...

More: At least 10 House lawmakers are backing a US trade panel’s probe of China’s biotech sector and related pricing practices, encouraging future executive action. In a letter sent to Secretary of the US International Trade ...
TL;DR: At least 10 House lawmakers are backing a US trade panel’s probe of China’s biotech sector and related pricing practices, encouraging future executive action.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Anthropic's life sciences plans: Mystery programs, Nobel hires, M&A and big ambition

A year ago, Anthropic’s life sciences plans were basically just a blog post by its CEO. In late 2024, Dario Amodei wrote a 13,000-word memo naming biology and neuroscience among his ...

More: Anthropic's life sciences plans: Mystery programs, Nobel hires, M&A and big ambition. A year ago, Anthropic’s life sciences plans were basically just a blog post by its CEO. In late 2024, Dario Amodei wrote a 13,000-word memo naming biology and neuroscience among his ...
TL;DR: A year ago, Anthropic’s life sciences plans were basically just a blog post by its CEO.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Scribe's $96M IPO; Scholar Rock awaits site classification for apitegromab

Scribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...

More: Scribe writes in $96M IPO: The gene edit&shy;ing biotech ex&shy;pects net pro&shy;ceeds of about $96 mil&shy;lion if it prices its … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Scribe writes in $96M IPO: The gene editing biotech expects net proceeds of about $96 million if it prices its Nasdaq listing at $14 per share, the midpoint of the ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

J&J, AbbVie said to have also looked at AtaiBeckley before Lilly’s $2.8B deal

Johnson & Johnson and AbbVie, the two pharma giants already in the psychedelic space, also eyed AtaiBeckley, according to a source familiar with the situation, but didn’t make an offer before Eli Lilly sealed its ...

More: John&shy;son & John&shy;son and Ab&shy;b&shy;Vie, the two phar&shy;ma gi&shy;ants al&shy;ready in the psy&shy;che&shy;del&shy;ic space, al&shy;so eyed AtaiBeck&shy;ley, ac&shy;cord&shy;ing to a source fa&shy;mil&shy;iar with the sit&shy;u&shy;a&shy;tion … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Johnson & Johnson and AbbVie, the two pharma giants already in the psychedelic space, also eyed AtaiBeckley, according to a source familiar with the situation, but didn’t make an offer before Eli Lilly sealed its ...
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Abbott hit by cyberattack on cancer diagnostics, LabCentral portal businesses

Abbott has been struck by several cyberattacks which targeted the medtech giant’s cancer diagnostics and LabCentral businesses.

More: Jul 19, 2026 2:44am Abbott cyberattack Diagnostics MedTech Abbott has been struck by a cyberattack that targeted the medtech giant’s cancer diagnostics and LabCentral businesses.  Abbott revealed the first attack on July 16 when it said in a statement that its cancer diagnostics business was hit by a “cyber incident in which there was unauthorized access to a limited number of…
TL;DR: Abbott has been struck by several cyberattacks which targeted the medtech giant’s cancer diagnostics and LabCentral businesses.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

BMS expands AI footprint with Nvidia, aiming for ‘most powerful AI factory in life sciences’

Bristol Myers Squibb has entered into an expanded collaboration with Nvidia to create the biggest supercomputer for drug R&D, according to the announcement.

TL;DR: Bristol Myers Squibb has entered into an expanded collaboration with Nvidia to create the biggest supercomputer for drug R&D, according to the announcement.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Scribe aims for $96M IPO to fund clinical push for lipid-lowering genetic meds

Scribe Therapeutics has put its IPO plans down on paper, showing the genetic medicine company hopes to raise $96 million through its public listing.

TL;DR: Scribe Therapeutics has put its IPO plans down on paper, showing the genetic medicine company hopes to raise $96 million through its public listing.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Tempus buys out cancer genomics partner Personalis in $1.5 billion deal

Tempus is boosting its cancer offerings with a deal to buy out Personalis three years after the pair first teamed up in oncology.

TL;DR: Tempus is boosting its cancer offerings with a deal to buy out Personalis three years after the pair first teamed up in oncology.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial

A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on determining the next steps for the osteoarthritis candidate.

More: Kolon’s cell-based gene therapy fails phase 3 osteoarthritis trial. A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints. With a second late-stage study scheduled to report data in October, the biotech is holding off on determining the next steps for the osteoarthritis candidate.
TL;DR: A phase 3 trial of Kolon TissueGene’s cell-based gene therapy has missed its co-primary endpoints.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

New €25 Million BioReliance Testing Facility Opens at Merck KGaA Global Headquarters in Germany

The 2,000-square-meter BioReliance facility in Darmstadt, Germany, will also offer GMP-compliant stability studies for monoclonal antibodies and cell therapies, addressing the growing demand for biologics testing across Europe. The post New €25 Million BioReliance Testing Facility Opens at Merck KGaA Global Headquarters in Germany appeared first on GEN - Genetic Engineering and Biotechnology News .

More: New €25 Million BioReliance Testing Facility Opens at Merck KGaA Global Headquarters in Germany. The 2,000-square-meter BioReliance facility in Darmstadt, Germany, will also offer GMP-compliant stability studies for monoclonal antibodies and cell therapies, addressing the growing demand for biologics testing across Europe.
TL;DR: The post New €25 Million BioReliance Testing Facility Opens at Merck KGaA Global Headquarters in Germany appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

UK biotech VC funding rebounds and reaches record high

UK biotechs attracted more venture capital funding in the second quarter of 2026 than in any full year since 2022, in a sign that the country is amid a fundraising revival as investors get attractive ...

More: UK biotechs at&shy;tract&shy;ed more ven&shy;ture cap&shy;i&shy;tal fund&shy;ing in the sec&shy;ond quar&shy;ter of 2026 than in any full year since 2022, in a sign that the … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: UK biotechs attracted more venture capital funding in the second quarter of 2026 than in any full year since 2022, in a sign that the country is amid a fundraising revival as investors get attractive ...
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Bristol Myers, Nvidia say they'll build 'most powerful' AI supercomputer in pharma

Bristol Myers Squibb said Monday it will build "the most advanced and energy-efficient AI" supercomputer system in the biopharma industry, deepening its relationship with Nvidia. The New Jersey-headquartered drugmaker will be the first pharma company ...

More: Bristol Myers Squibb said Monday it will build "the most advanced and energy-efficient AI" supercomputer system in the biopharma industry, deepening its relationship with Nvidia. The New Jersey-headquartered drugmaker will be the first pharma company ...
TL;DR: Bristol Myers Squibb said Monday it will build "the most advanced and energy-efficient AI" supercomputer system in the biopharma industry, deepening its relationship with Nvidia.
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Geopolitics ‘chills’ British biotech IPO plans, despite $2B in Q2 VC funds

Geopolitical uncertainty has continued to “chill” IPO sentiment among British biotechs, an industry leader has told Fierce, even as the sector saw second-quarter venture capital funding reach a five-year high.

TL;DR: Geopolitical uncertainty has continued to “chill” IPO sentiment among British biotechs, an industry leader has told Fierce, even as the sector saw second-quarter venture capital funding reach a five-year high.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

‘A rising tide scenario’: Why other Big Pharmas could follow Lilly into psychedelics

After Eli Lilly dived into the psychedelics space with a $2.8 billion upfront acquisition of AtaiBeckley last week, industry experts told Fierce that the deal would give the space added momentum.

TL;DR: After Eli Lilly dived into the psychedelics space with a $2.8 billion upfront acquisition of AtaiBeckley last week, industry experts told Fierce that the deal would give the space added momentum.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Latigo preps IPO to fund non-opioid pain drug rival to Vertex’s Journax

Latigo Biotherapeutics is preparing to go public in order to bankroll the development of its clinical-stage pipeline of non-opioid pain management drugs.

TL;DR: Latigo Biotherapeutics is preparing to go public in order to bankroll the development of its clinical-stage pipeline of non-opioid pain management drugs.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

StockWatch: Lilly’s Up-to-$3.8B Deal for AtaiBeckley a Good Trip for Psychedelic Drugs, Analysts and Investors Agree

Eli Lilly agreed to acquire AtaiBeckley for up to $3.8 billion—of which Lilly will pay $2.8 billion upfront. The deal, set to close in the third quarter, expands Lilly’s neuroscience portfolio by adding AtaiBeckley's pipeline led by BPL-003 (mebufotenin benzoate). The post StockWatch: Lilly’s Up-to-$3.8B Deal for AtaiBeckley a Good Trip for Psychedelic Drugs, Analysts and Investors Agree appeared first on GEN - Genetic Engineering and Biotechnology News .

More: StockWatch: Lilly’s Up-to-$3.8B Deal for AtaiBeckley a Good Trip for Psychedelic Drugs, Analysts and Investors Agree. The deal, set to close in the third quarter, expands Lilly’s neuroscience portfolio by adding AtaiBeckley's pipeline led by BPL-003 (mebufotenin benzoate). The post StockWatch: Lilly’s Up-to-$3.
TL;DR: Eli Lilly agreed to acquire AtaiBeckley for up to $3.8 billion—of which Lilly will pay $2.8 billion upfront.
Read original at Genengnews
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Biotronik Neuro snaps up spinal cord stimulation portfolio from Soin Neuroscience for next-gen pain project

Biotronik Neuro has acquired a portfolio of spinal cord stimulation patents from the Ohio-based medical device company Soin Neuroscience as the pair look to create “a next-generation spinal cord stimulation program.”

TL;DR: Biotronik Neuro has acquired a portfolio of spinal cord stimulation patents from the Ohio-based medical device company Soin Neuroscience as the pair look to create “a next-generation spinal cord stimulation program.”
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Organ Aging Linked to Breakdown in Immune Cell Interaction and Senescent Neutrophil Clearance

A study in mice and in human cells found that blocking a single receptor on tissue-resident macrophages promoted clearance of accumulating senescent neutrophils, preserved the youthfulness of multiple organs in mice, and substantially slowed cognitive decline. The post Organ Aging Linked to Breakdown in Immune Cell Interaction and Senescent Neutrophil Clearance appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Organ Aging Linked to Breakdown in Immune Cell Interaction and Senescent Neutrophil Clearance. A study in mice and in human cells found that blocking a single receptor on tissue-resident macrophages promoted clearance of accumulating senescent neutrophils, preserved the youthfulness of multiple organs in mice, and substantially slowed cognitive decline.
TL;DR: The post Organ Aging Linked to Breakdown in Immune Cell Interaction and Senescent Neutrophil Clearance appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Midsize biotechs press White House to drop CMS pricing rules

A number of midsize biotech companies have met with White House and HHS officials in the last week, presenting their case for why two pending CMS pricing models could hinder their business and should not ...

More: A num&shy;ber of mid&shy;size biotech com&shy;pa&shy;nies have met with White House and HHS of&shy;fi&shy;cials in the last week, pre&shy;sent&shy;ing their case for why two pend&shy;ing … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: A number of midsize biotech companies have met with White House and HHS officials in the last week, presenting their case for why two pending CMS pricing models could hinder their business and should not ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Celcuity got its cancer drug approved. Then its stock dipped

The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated. What Wall Street didn’t expect was that the drug could take until the end of the quarter to launch. ...

More: Celcuity got its cancer drug approved. The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated. What Wall Street didn’t expect was that the drug could take until the end of the quarter to launch.
TL;DR: The FDA’s approval for Celcuity’s cancer drug Revtorpyk on Tuesday was widely anticipated.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Genetic Study Links Excessive Sweating to Neurological Dysfunction

Genetic evidence links hyperhidrosis to nerve overstimulation rather than simple sweat gland dysfunction, a finding that could allow existing medicines to be repurposed for targeted treatment. The post Genetic Study Links Excessive Sweating to Neurological Dysfunction appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Genetic Study Links Excessive Sweating to Neurological Dysfunction. Genetic evidence links hyperhidrosis to nerve overstimulation rather than simple sweat gland dysfunction, a finding that could allow existing medicines to be repurposed for targeted treatment.
TL;DR: The post Genetic Study Links Excessive Sweating to Neurological Dysfunction appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

BlossomHill eyes IPO as fertilizer to grow taller in crowded cancer fields

Another biotech is squeezing into the crowded IPO waiting room just in time for the weekend. BlossomHill Therapeutics, a San Diego-based oncology outfit focused on small molecules, has filed paperwork with the Securities and Exchange Commission to publicly offer stock for the first time.

More: BlossomHill eyes IPO as fertilizer to grow taller in crowded cancer fields. Another biotech is squeezing into the crowded IPO waiting room just in time for the weekend. BlossomHill Therapeutics, a San Diego-based oncology outfit focused on small molecules, has filed paperwork with the Securities and Exchange Commission to publicly offer stock for the first time.
TL;DR: Another biotech is squeezing into the crowded IPO waiting room just in time for the weekend.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Parkinson’s in the Clinic, Insilico enters Phase III, Vertex Acquires Crinetics

In this episode of GEN 's Touching Base , editors talk about neuroscience research updates, insights into how investors are approaching the changing AI landscape, and business updates on profits and buyouts. The post Parkinson’s in the Clinic, Insilico enters Phase III, Vertex Acquires Crinetics appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Parkinson’s in the Clinic, Insilico enters Phase III, Vertex Acquires Crinetics. In this episode of GEN 's Touching Base , editors talk about neuroscience research updates, insights into how investors are approaching the changing AI landscape, and business updates on profits and buyouts.
TL;DR: The post Parkinson’s in the Clinic, Insilico enters Phase III, Vertex Acquires Crinetics appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

KRAS-Targeted Vaccine Crosses First Clinical Milestone in Pancreatic Cancer Prevention

A first-in-human KRAS-targeted pancreatic cancer prevention vaccine was found to be safe, elicited durable immune responses in 90% of high-risk participants, and showed encouraging signs of slowing or reversing precancerous lesions. The post KRAS-Targeted Vaccine Crosses First Clinical Milestone in Pancreatic Cancer Prevention appeared first on GEN - Genetic Engineering and Biotechnology News .

More: KRAS-Targeted Vaccine Crosses First Clinical Milestone in Pancreatic Cancer Prevention. A first-in-human KRAS-targeted pancreatic cancer prevention vaccine was found to be safe, elicited durable immune responses in 90% of high-risk participants, and showed encouraging signs of slowing or reversing precancerous lesions.
TL;DR: The post KRAS-Targeted Vaccine Crosses First Clinical Milestone in Pancreatic Cancer Prevention appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

GSK plans large study to see if shingles vaccine can prevent dementia

LONDON — Over the past several years, data scientists searching through national health records have noticed something surprising about people who had been vaccinated for shingles: They were less likely to develop Alzheimer’s. Now a massive ...

More: LON&shy;DON — Over the past sev&shy;er&shy;al years, da&shy;ta sci&shy;en&shy;tists search&shy;ing through na&shy;tion&shy;al health records have no&shy;ticed some&shy;thing sur&shy;pris&shy;ing about peo&shy;ple who had been vac&shy;ci&shy;nat&shy;ed for shin&shy;gles: … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: LONDON — Over the past several years, data scientists searching through national health records have noticed something surprising about people who had been vaccinated for shingles: They were less likely to develop Alzheimer’s.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Dimerix buys a kidney injury drug; Arpeggio appears to be winding down

Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury, known ...

More: Dimerix buys a kidney injury drug; Arpeggio appears to be winding down. Plus, news about Takeda, Novartis and Regenxbio. 🤝 Mission sells kidney injury drug to Dimerix: Dimerix will pay $5 million upfront for Mission’s Phase 2-ready candidate for acute kidney injury, known ...
TL;DR: Plus, news about Takeda, Novartis and Regenxbio.
Read original at Endpoints
Further reading: PubMedGenome.govBioTech PrimerWikipedia

The end for GSK’s chronic cough treatment 

Sonothera's ultrasound gene therapy delivery, a new Alzheimer's drug controversy, and more biotech news from The Readout

More: Today, we explore a gene therapy approach that’s drawing excitement but also skepticism, and see that Jennifer Doudna is moving into AI-designed gene editors that push beyond evolution.  Plus, our trusty podcasters unpack the buzzy prediction market Kalshi’s move into biotech. Your morning rundown of the science, politics, and money driving biotech today
TL;DR: Sonothera's ultrasound gene therapy delivery, a new Alzheimer's drug controversy, and more biotech news from The Readout
Read original at Statnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador

Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.

More: Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador. Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.
TL;DR: Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Tagrisso-chasing BlossomHill enters Nasdaq queue as biotech IPOs flourish

Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as five

More: Tagrisso-chasing BlossomHill enters Nasdaq queue as biotech IPOs flourish. Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales. This time around, it's a summer IPO party as five
TL;DR: Last summer, zero biotechs made it onto the public markets as the industry weathered a seven-month dry spell for initial share sales.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

5 emerging biotech hubs

Boston. San Francisco. Beijing? The global biotech industry has long been concentrated in a handful of cities. But which emerging hubs could become dominant forces in biotech in the decades ahead?

More: 5 emerging biotech hubs. The global biotech industry has long been concentrated in a handful of cities. But which emerging hubs could become dominant forces in biotech in the decades ahead?
TL;DR: But which emerging hubs could become dominant forces in biotech in the decades ahead?
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Gene Therapy Partners Aim to Enhance Protein Expression

Avenue Biosciences´ machine learning-powered platform engineers and screens signal peptide variants to increase protein secretion from cells. Circio’s circVec technology has demonstrated significantly enhanced and durable gene expression in several tissues. The post Gene Therapy Partners Aim to Enhance Protein Expression appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Avenue Biosciences´ machine learning-powered platform engineers and screens signal peptide variants to increase protein secretion from cells. Circio’s circVec technology has demonstrated significantly enhanced and durable gene expression in several tissues.
TL;DR: The post Gene Therapy Partners Aim to Enhance Protein Expression appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

GSK drops Phase 3 chronic cough drug in a blow to $2B Bellus Health buyout

In a major stumble for GSK’s $2 billion acquisition of Bellus Health, the UK pharma said Friday it is ending development of camlipixant in refractory chronic cough (RCC). The decision comes ...

More: In a ma&shy;jor stum&shy;ble for GSK’s $2 bil&shy;lion ac&shy;qui&shy;si&shy;tion of Bel&shy;lus Health, the UK phar&shy;ma said Fri&shy;day it is end&shy;ing de&shy;vel&shy;op&shy;ment … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: In a major stumble for GSK’s $2 billion acquisition of Bellus Health, the UK pharma said Friday it is ending development of camlipixant in refractory chronic cough (RCC).
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Zealand Pharma gets its US marketing leader from Lilly; Bexorg turns to Biohaven for CSO hire

→ Silvia Luque announced on LinkedIn that she was named head of US marketing at Zealand Pharma after 13 years in various roles at obesity competitor Eli Lilly. She had been ...

More: → Sil&shy;via Luque an&shy;nounced on LinkedIn that she was named head of US mar&shy;ket&shy;ing at Zealand Phar&shy;ma af&shy;ter 13 years in … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: → Silvia Luque announced on LinkedIn that she was named head of US marketing at Zealand Pharma after 13 years in various roles at obesity competitor Eli Lilly.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

GSK axes key cough drug candidate after phase 3 data end blockbuster hopes

GSK has ended development of camlipixant in chronic cough after delivering mixed phase 3 data, dealing a major blow to a potential blockbuster that analysts saw as the key 2026 catalyst for the drugmaker.

TL;DR: GSK has ended development of camlipixant in chronic cough after delivering mixed phase 3 data, dealing a major blow to a potential blockbuster that analysts saw as the key 2026 catalyst for the drugmaker.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Dimerix snaps up Mission’s stalled, phase 2-ready kidney disease candidate in $292M deal

Dimerix has bought an acute kidney injury drug from Mission Therapeutics, paying $5 million upfront and committing up to $287 million in milestones for the phase 2-ready asset.

TL;DR: Dimerix has bought an acute kidney injury drug from Mission Therapeutics, paying $5 million upfront and committing up to $287 million in milestones for the phase 2-ready asset.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Takeda’s zasocitinib proves ‘top-notch’ for difficult-to-treat psoriasis in phase 3 update

Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.

TL;DR: Takeda has unveiled more data from its phase 3 trials of zasocitinib, demonstrating that the once-daily pill was able to clear or almost clear scalp psoriasis in 75% of patients.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Modular Antibody–ADC Click Chemistry Overcomes Tumor Drug Resistance in Mice

The team’s strategy—called antibody–ADC click—relies on the rapid ligation between trans ‑cyclooctene (TCO) and tetrazine moieties. The post Modular Antibody–ADC Click Chemistry Overcomes Tumor Drug Resistance in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Modular Antibody–ADC Click Chemistry Overcomes Tumor Drug Resistance in Mice. The team’s strategy—called antibody–ADC click—relies on the rapid ligation between trans ‑cyclooctene (TCO) and tetrazine moieties. The post Modular Antibody–ADC Click Chemistry Overcomes Tumor Drug Resistance in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Modular Antibody–ADC Click Chemistry Overcomes Tumor Drug Resistance in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Mirador unveils part of pipeline with drug from Kira to rival Tavneos

Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline. The San Diego biotech said Thursday it reached a deal for worldwide ...

More: Mirador unveils part of pipeline with drug from Kira to rival Tavneos. Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline. The San Diego biotech said Thursday it reached a deal for worldwide ...
TL;DR: Mirador Therapeutics, the secretive immune disease biotech with more than $650 million in VC funding, is finally revealing a piece of its pipeline.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Predicting biotech clinical trials & a new Alzheimer’s drug controversy

This week on "The Readout LOUD" podcast: a new Alzheimer's drug controversy and prediction markets for clinical trials and FDA drug reviews. Listen now.

More: Allison covers what hot startups are getting up to, and who’s financing them. She is also co-host of the weekly biotech podcast, “ The Readout Loud .” You can reach Allison on Signal at AllisonDeAngelis.01. She is also co-host of the weekly biotech podcast, “ The Readout Loud .” You can reach Allison on Signal at AllisonDeAngelis.01.
TL;DR: This week on "The Readout LOUD" podcast: a new Alzheimer's drug controversy and prediction markets for clinical trials and FDA drug reviews.
Read original at Statnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Understanding Agentic AI in Clinical Development

Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but because the question often produces the wrong conversation.

TL;DR: Earlier this year, my colleague Matt Harrington suggested that clinical leaders should stop asking whether their organizations have an “AI strategy”, not because strategy doesn’t matter, but because the question often produces the wrong conversation.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

AI-Designed Synthetic CRISPR-like Nucleases Show Activity in Cells

Scientists used artificial intelligence to design CRISPR nucleases with properties not found in nature, achieving activity that matches or exceeds natural enzymes despite the proteins' complex, multi-domain structure. The post AI-Designed Synthetic CRISPR-like Nucleases Show Activity in Cells appeared first on GEN - Genetic Engineering and Biotechnology News .

More: AI-Designed Synthetic CRISPR-like Nucleases Show Activity in Cells. Scientists used artificial intelligence to design CRISPR nucleases with properties not found in nature, achieving activity that matches or exceeds natural enzymes despite the proteins' complex, multi-domain structure.
TL;DR: The post AI-Designed Synthetic CRISPR-like Nucleases Show Activity in Cells appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Nobel Laureate Jennifer Doudna enters AI protein design arena

Jennifer Doudna, Ph.D., the Nobel Laureate best known for co-inventing the CRISPR system that has become the foundation for gene-editing, is dipping her toes into a new, buzzy field: AI-powered protein design.

TL;DR: Jennifer Doudna, Ph.D., the Nobel Laureate best known for co-inventing the CRISPR system that has become the foundation for gene-editing, is dipping her toes into a new, buzzy field: AI-powered protein design.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

See, Blind Mice: Consortium’s Drugs Restore Sight

Researchers developed a series of light-activated small molecule drugs that mimic the function of the light-sensing photoreceptor cells that degenerate in diseases such as age-related macular degeneration and retinitis pigmentosa, and which in tests restored sight in blind mice. The post See, Blind Mice: Consortium’s Drugs Restore Sight appeared first on GEN - Genetic Engineering and Biotechnology News .

More: See, Blind Mice: Consortium’s Drugs Restore Sight. Researchers developed a series of light-activated small molecule drugs that mimic the function of the light-sensing photoreceptor cells that degenerate in diseases such as age-related macular degeneration and retinitis pigmentosa, and which in tests restored sight in blind mice.
TL;DR: The post See, Blind Mice: Consortium’s Drugs Restore Sight appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Kelun pads efficacy profile of Merck-partnered ADC; Europe will have to wait for Boehringer's Hernexeos

Plus, news about Vogenx and Orakl Oncology. 🇨🇳 Kelun touts China data for sac-TMT: Kelun-Biotech announced on Tuesday that its Merck-partnered antibody-drug conjugate sacituzumab tirumotecan succeeded as a first-line treatment in ...

More: Kelun pads efficacy profile of Merck-partnered ADC; Europe will have to wait for Boehringer's Hernexeos. Plus, news about Vogenx and Orakl Oncology. 🇨🇳 Kelun touts China data for sac-TMT: Kelun-Biotech announced on Tuesday that its Merck-partnered antibody-drug conjugate sacituzumab tirumotecan succeeded as a first-line treatment in ...
TL;DR: Plus, news about Vogenx and Orakl Oncology.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Q&A: Betty Tijms wants to stop treating Alzheimer’s as a single disease

LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease. But not everyone with buildup of these problematic proteins ...

More: Q&A: Betty Tijms wants to stop treating Alzheimer’s as a single disease. LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease. But not everyone with buildup of these problematic proteins ...
TL;DR: LONDON — For more than a century, scientists studying Alzheimer’s have largely focused their efforts on two proteins — amyloid and tau — that clearly accumulate in the disease.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

US drug shortages rise for third straight quarter, hurt by lone suppliers

The number of drugs in shortage in the US rose for a third straight quarter, a situation complicated by the fact that almost half of the medicines in tight supply rely only on a single ...

More: The num&shy;ber of drugs in short&shy;age in the US rose for a third straight quar&shy;ter, a sit&shy;u&shy;a&shy;tion com&shy;pli&shy;cat&shy;ed by the fact that al&shy;most half of … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The number of drugs in shortage in the US rose for a third straight quarter, a situation complicated by the fact that almost half of the medicines in tight supply rely only on a single ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Why Axiom hopes it’s ‘solved 2 major potholes’ that have hurt other stem cell biotechs

When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for their approach to targeting the brain.

TL;DR: When Axiom's stem cell therapy demonstrated a 0% mortality rate over two years in potentially fatal newborn neurological diseases this week, the biotech's leadership saw a broader validation for their approach to targeting the brain.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Racing Takeda, InnoCare reports TYK2 inhibitor win in phase 2 vitiligo trial

A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.

TL;DR: A phase 2 trial of InnoCare Pharma’s TYK2 inhibitor soficitinib in nonsegmental vitiligo has hit its primary endpoint, clearing the Chinese biotech to advance into the phase 3 part of the study.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Autolomous and Cellular Origins Expand Cell Therapy Manufacturing Process

The combined solution using Constellation and autoloMATE overcomes fragmentation, limited visibility, and the absence of standardized, interoperable data flows without replacing existing processes, enabling manufacturers to scale to commercially viable levels. The post Autolomous and Cellular Origins Expand Cell Therapy Manufacturing Process appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Autolomous and Cellular Origins Expand Cell Therapy Manufacturing Process. The combined solution using Constellation and autoloMATE overcomes fragmentation, limited visibility, and the absence of standardized, interoperable data flows without replacing existing processes, enabling manufacturers to scale to commercially viable levels.
TL;DR: The post Autolomous and Cellular Origins Expand Cell Therapy Manufacturing Process appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Sanofi sues Pfizer, Moderna over tech used in mRNA vaccines

Sanofi is suing Moderna and Pfizer for allegedly violating its mRNA patents, adding to a growing list of companies making similar complaints. On Tuesday, Sanofi filed two lawsuits in the New Jersey District Court. The ...

More: Sanofi sues Pfizer, Moderna over tech used in mRNA vaccines. Sanofi is suing Moderna and Pfizer for allegedly violating its mRNA patents, adding to a growing list of companies making similar complaints. On Tuesday, Sanofi filed two lawsuits in the New Jersey District Court.
TL;DR: Sanofi is suing Moderna and Pfizer for allegedly violating its mRNA patents, adding to a growing list of companies making similar complaints.
Read original at Endpoints
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Lilly bets $2.8B upfront on psychedelics in deal to buy AtaiBeckley

Eli Lilly said on Thursday it will buy psychedelic drug developer AtaiBeckley for $2.8 billion upfront, in a move that further spotlights big pharma’s increasing interest in psychedelics after years of watching from the sidelines. ...

More: Eli Lil&shy;ly said on Thurs&shy;day it will buy psy&shy;che&shy;del&shy;ic drug de&shy;vel&shy;op&shy;er AtaiBeck&shy;ley for $2.8 bil&shy;lion up&shy;front, in a move that fur&shy;ther spot&shy;lights big phar&shy;ma’s in&shy;creas&shy;ing … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Eli Lilly said on Thursday it will buy psychedelic drug developer AtaiBeckley for $2.8 billion upfront, in a move that further spotlights big pharma’s increasing interest in psychedelics after years of watching from the sidelines.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Lilly buys AtaiBeckley for $2.8B upfront to challenge J&J for psychedelic mental health market

Eli Lilly has struck a deal to buy AtaiBeckley for $2.8 billion upfront, continuing its takeover spree to move into a psychedelic mental health sector targeted by companies including Johnson & Johnson.

More: A phase 2b trial  linked BPL-003 to statistically significant improvements in patients with treatment-resistant depression (TRD) starting Day 2. Lilly has tied $1 per share to the start of phase 3 trials of VLS-01, plus another $1 per share to U.S. A further 50 cents per share is tied to the approval and rescheduling of BPL-003. 
TL;DR: Eli Lilly has struck a deal to buy AtaiBeckley for $2.8 billion upfront, continuing its takeover spree to move into a psychedelic mental health sector targeted by companies including Johnson & Johnson.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

Merck beats AstraZeneca to first approval for first PCSK9 pill

As in football, so in pharmaceuticals: the English have been beaten. Merck has outpaced AstraZeneca in the race to get the first US approval for an oral form of a particular kind of cholesterol-lowering medication. ...

More: As in football, so in pharmaceuticals: the English have been beaten. Merck has outpaced AstraZeneca in the race to get the first US approval for an oral form of a particular kind of cholesterol-lowering medication.
TL;DR: Merck has outpaced AstraZeneca in the race to get the first US approval for an oral form of a particular kind of cholesterol-lowering medication.
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Vogenx joins the IPO queue to fund phase 2-stage metabolic drug

Jul 16, 2026 5:19am Vogenx metabolic drugs IPO biotech IPO Vogenx has joined the growing queue for the Nasdaq, as the metabolic biotech eyes an IPO to fund its SGLT1 inhibitor.

More: Jul 16, 2026 5:19am Vogenx metabolic drugs IPO biotech IPO Vogenx has joined the growing queue for the Nasdaq, as the metabolic biotech eyes an IPO to fund its SGLT1 inhibitor. But top of the list of spending priorities is the biotech’s lead asset mizagliflozin, according to a Securities and Exchange Commission filing .
TL;DR: Vogenx has joined the growing queue for the Nasdaq, as the metabolic biotech eyes an IPO to fund its SGLT1 inhibitor.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Opinion: The growing fang-to-pharmacy pipeline

“Some of the most powerful medicines we will ever find are already here, carried in the fangs, stingers, and saliva of creatures we’ve been taught to fear,” writes Steve Midway.

More: The unrealized pain and suffering bound up in venom molecules is real, but to a growing number of scientists and pharmaceutical companies, they represent something else entirely: a hidden medicine cabinet. Each venom is a unique cocktail of peptides and proteins that can cause muscular paralysis, tissue destruction, cardiac arrest, or other effects.
TL;DR: “Some of the most powerful medicines we will ever find are already here, carried in the fangs, stingers, and saliva of creatures we’ve been taught to fear,” writes Steve Midway.
Read original at Statnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Increased Levels of Micro- and Nanoplastics Found in the Blood of Heart Attack Patients

A human study showed that heart attack patients had higher levels of micro- and nanoplastics in their blood, compared with patients diagnosed with chronic ischemic heart disease and normal controls. The post Increased Levels of Micro- and Nanoplastics Found in the Blood of Heart Attack Patients appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Increased Levels of Micro- and Nanoplastics Found in the Blood of Heart Attack Patients. A human study showed that heart attack patients had higher levels of micro- and nanoplastics in their blood, compared with patients diagnosed with chronic ischemic heart disease and normal controls.
TL;DR: The post Increased Levels of Micro- and Nanoplastics Found in the Blood of Heart Attack Patients appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Ketogenic Diet Shows Opposite Effects on Cancer Risk in Mouse Small Intestine and Colon

Ketogenic diets increased small intestinal tumors but suppressed colon tumors in mice. The effects were driven by dietary fat metabolism—not ketone bodies—highlighting tissue-specific cancer risks and benefits. The post Ketogenic Diet Shows Opposite Effects on Cancer Risk in Mouse Small Intestine and Colon appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Ketogenic diets increased small intestinal tumors but suppressed colon tumors in mice. The effects were driven by dietary fat metabolism—not ketone bodies—highlighting tissue-specific cancer risks and benefits. The post Ketogenic Diet Shows Opposite Effects on Cancer Risk in Mouse Small Intestine and Colon appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Ketogenic Diet Shows Opposite Effects on Cancer Risk in Mouse Small Intestine and Colon appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

FDA acting chief walks back Makary's practice of policymaking through journals

The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face formally addresses one of the ...

More: FDA acting chief walks back Makary's practice of policymaking through journals. The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face formally addresses one of the ...
TL;DR: The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy.
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Senate committee questions CDC pick on political interference over vaccines

Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been without permanent leadership for most ...

More: Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been without permanent leadership for most ...
TL;DR: Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Braveheart aims for freedom with IPO to support Hengrui-licensed cardio asset

It appears Braveheart Bio isn’t going to let Big Pharma take its freedom anytime soon, as the company is aiming for a Nasdaq listing to move its phase 3 cardiovascular drug forward.

TL;DR: It appears Braveheart Bio isn’t going to let Big Pharma take its freedom anytime soon, as the company is aiming for a Nasdaq listing to move its phase 3 cardiovascular drug forward.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

J&J restructures pharma manufacturing footprint at cost of up to $750M 

Johnson & Johnson is anticipating as much as $750 million in costs to restructure its pharmaceutical supply chain and exit factories, moves that are coming as it pushes ahead with its $55 billion pledge to ...

More: John&shy;son & John&shy;son is an&shy;tic&shy;i&shy;pat&shy;ing as much as $750 mil&shy;lion in costs to re&shy;struc&shy;ture its phar&shy;ma&shy;ceu&shy;ti&shy;cal sup&shy;ply chain and ex&shy;it fac&shy;to&shy;ries, moves that are com&shy;ing … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Johnson & Johnson is anticipating as much as $750 million in costs to restructure its pharmaceutical supply chain and exit factories, moves that are coming as it pushes ahead with its $55 billion pledge to ...
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Eli Lilly invests in Oura to support patients on GLP-1 drugs

Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications. An Oura spokesperson declined to share the size of ...

More: Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications. An Oura spokesperson declined to share the size of ...
TL;DR: Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications.
Read original at Endpoints
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Modular Modeling Drives Smarter mRNA Manufacturing

A modular mechanistic modeling framework is helping transform mRNA in vitro transcription by enabling faster optimization, streamlined scale-up, and quality-by-design strategies, giving bioprocess developers a powerful digital tool to improve manufacturing efficiency and product consistency. The post Modular Modeling Drives Smarter mRNA Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Modular Modeling Drives Smarter mRNA Manufacturing. A modular mechanistic modeling framework is helping transform mRNA in vitro transcription by enabling faster optimization, streamlined scale-up, and quality-by-design strategies, giving bioprocess developers a powerful digital tool to improve manufacturing efficiency and product consistency.
TL;DR: The post Modular Modeling Drives Smarter mRNA Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Free-Floating Bioelectronic Sensors for Fermentation Monitoring

A network of free-floating hybrid microbial-electronic sensors could provide data on solution mixing and transit time, as well as DO, temperature, pH, and other standard parameters, improving process monitoring and predictions. The post Free-Floating Bioelectronic Sensors for Fermentation Monitoring appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Free-Floating Bioelectronic Sensors for Fermentation Monitoring. A network of free-floating hybrid microbial-electronic sensors could provide data on solution mixing and transit time, as well as DO, temperature, pH, and other standard parameters, improving process monitoring and predictions.
TL;DR: The post Free-Floating Bioelectronic Sensors for Fermentation Monitoring appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

AI Could Give CGT Sector Deeper Manufacturing Insights and Greater Control

AI can help cell and gene therapy firms gain deeper insights about their complex production processes. The ultimate benefit of the technology will be helping industry move from reactive to predictive manufacturing. The post AI Could Give CGT Sector Deeper Manufacturing Insights and Greater Control appeared first on GEN - Genetic Engineering and Biotechnology News .

More: AI can help cell and gene therapy firms gain deeper insights about their complex production processes. The ultimate benefit of the technology will be helping industry move from reactive to predictive manufacturing. The post AI Could Give CGT Sector Deeper Manufacturing Insights and Greater Control appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post AI Could Give CGT Sector Deeper Manufacturing Insights and Greater Control appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

In vivo CAR T Industry Leaps Forward with Challenges Ahead

The emerging new class of in vivo CAR T therapeutics is seen by regulators as gene therapies with risks of off-target effects to patients. Manufacturers need to rise to the challenge. The post <i>In vivo</i> CAR T Industry Leaps Forward with Challenges Ahead appeared first on GEN - Genetic Engineering and Biotechnology News .

More: The emerging new class of in vivo CAR T therapeutics is seen by regulators as gene therapies with risks of off-target effects to patients. Manufacturers need to rise to the challenge. The post <i>In vivo</i> CAR T Industry Leaps Forward with Challenges Ahead appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post <i>In vivo</i> CAR T Industry Leaps Forward with Challenges Ahead appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

J&J touts Icotyde prescriptions, but not sales, in first full quarter

Johnson & Johnson teased some details on Wednesday morning about how the launch of its expected blockbuster Icotyde performed in the second quarter. Without disclosing how much revenue the plaque psoriasis drug pulled in during ...

More: J&J touts Icotyde prescriptions, but not sales, in first full quarter. Johnson & Johnson teased some details on Wednesday morning about how the launch of its expected blockbuster Icotyde performed in the second quarter. Without disclosing how much revenue the plaque psoriasis drug pulled in during ...
TL;DR: Without disclosing how much revenue the plaque psoriasis drug pulled in during ...
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Chronic Pancreatitis Therapies Informed by Patient-Derived Organoids

Organoids have become a prevalent tool to bridge the gap between cell and human studies. A new organoid study uncovers chronic pancreatitis development and identifies possible therapeutic strategies.  The post Chronic Pancreatitis Therapies Informed by Patient-Derived Organoids appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Approximately three million people worldwide struggle with chronic pancreatitis, for which there is no cure. In a study published in  Cell Stem Cell  titled “ Patient-derived organoids reveal ductal dysfunction and CFTR-modulator responses in chronic pancreatitis ,” researchers from Salk Institute have developed an organoid platform to uncover the mechanism of chronic pancreat…
TL;DR: Organoids have become a prevalent tool to bridge the gap between cell and human studies. A new organoid study uncovers chronic pancreatitis development and identifies possible therapeutic strategies.  The post Chronic Pancreatitis Therapies Informed by Patient-Derived Organoids appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Big Pharma-backed AdvanCell, flush with $315M series D, ready to put radiotherapy pedal to the metal

Less than a month after locking down a lease for a new U.S. headquarters, radiotherapy outfit AdvanCell is poised to push its lead prostate cancer candidate into phase 3 development with the help of a $315 million series D.

More: Big Pharma-backed AdvanCell, flush with $315M series D, ready to put radiotherapy pedal to the metal. Less than a month after locking down a lease for a new U.S. headquarters, radiotherapy outfit AdvanCell is poised to push its lead prostate cancer candidate into phase 3 development with the help of a $315 million series D.
TL;DR: headquarters, radiotherapy outfit AdvanCell is poised to push its lead prostate cancer candidate into phase 3 development with the help of a $315 million series D.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

J&J axes eye disease gene therapy after key phase 2b readout

Johnson & Johnson has stopped development of an eye disease gene therapy after reviewing data from one of its key readouts for 2026.

TL;DR: Johnson & Johnson has stopped development of an eye disease gene therapy after reviewing data from one of its key readouts for 2026.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Nava Therapeutics emerges with $89M for lipid nanoparticles

Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company told Endpoints News in ...

More: Na&shy;va Ther&shy;a&shy;peu&shy;tics, a se&shy;cre&shy;tive start&shy;up that’s been work&shy;ing on a new gen&shy;er&shy;a&shy;tion of lipid nanopar&shy;ti&shy;cles that tar&shy;get the bone mar&shy;row, im&shy;mune cells and the kid&shy;ney … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company told Endpoints News in ...
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Braveheart files for IPO to fund Phase 3 of Hengrui's Cytokinetics rival

Biotechs are sprinting to the IPO queue. In the industry's fourth IPO filing in two weeks, Braveheart Bio is seeking a Nasdaq listing to fuel Phase 3 testing of a cardio drug that could potentially ...

More: In the in&shy;dus&shy;try’s fourth IPO fil&shy;ing in two weeks, Brave&shy;heart Bio is seek&shy;ing a Nas&shy;daq list&shy;ing to fu&shy;el … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: In the industry's fourth IPO filing in two weeks, Braveheart Bio is seeking a Nasdaq listing to fuel Phase 3 testing of a cardio drug that could potentially ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Insilico, Bora Pharma reveal plans for AI-driven manufacturing company

Insilico Medicine and Taiwan-based CDMO Bora Pharmaceuticals are launching a new company with an AI-driven biologics manufacturing platform in a bid to compete with service providers headquartered in China. “What we are trying to create ...

More: In&shy;sil&shy;i&shy;co Med&shy;i&shy;cine and Tai&shy;wan-based CD&shy;MO Bo&shy;ra Phar&shy;ma&shy;ceu&shy;ti&shy;cals are launch&shy;ing a new com&shy;pa&shy;ny with an AI-dri&shy;ven bi&shy;o&shy;log&shy;ics man&shy;u&shy;fac&shy;tur&shy;ing plat&shy;form in a bid to com&shy;pete with ser&shy;vice … Get free access to a limited number of articles, plus choose newsletters t…
TL;DR: Insilico Medicine and Taiwan-based CDMO Bora Pharmaceuticals are launching a new company with an AI-driven biologics manufacturing platform in a bid to compete with service providers headquartered in China.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

AAIC: Roche ‘very interested’ in testing tau for Alzheimer’s despite focus on phase 3-stage amyloid drug

Roche’s biggest bet in the Alzheimer’s disease space may be its phase 3-stage amyloid asset, but the Swiss pharma is keeping its options open when it comes to targeting tau.

TL;DR: Roche’s biggest bet in the Alzheimer’s disease space may be its phase 3-stage amyloid asset, but the Swiss pharma is keeping its options open when it comes to targeting tau.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Veradermics declares first efficacy win in women for hair loss drug

Veradermics is for the first time reporting positive efficacy of its oral formulation of minoxidil in female pattern hair loss, which broadens the market potential of its flagship asset. In a mid-stage trial, women with ...

More: Veradermics is for the first time reporting positive efficacy of its oral formulation of minoxidil in female pattern hair loss, which broadens the market potential of its flagship asset. In a mid-stage trial, women with ...
TL;DR: Veradermics is for the first time reporting positive efficacy of its oral formulation of minoxidil in female pattern hair loss, which broadens the market potential of its flagship asset.
Read original at Endpoints
Further reading: PubMedGenome.govBioTech PrimerWikipedia

I&I startup Attovia files to go public as biotech listings momentum builds

The tally of biotechs waiting to list in the coming weeks has increased to three, after biologics maker Attovia Therapeutics filed for an initial public offering on Tuesday after the market closed. Attovia, which has ...

More: The tal&shy;ly of biotechs wait&shy;ing to list in the com&shy;ing weeks has in&shy;creased to three, af&shy;ter bi&shy;o&shy;log&shy;ics mak&shy;er At&shy;tovia Ther&shy;a&shy;peu&shy;tics filed for an ini&shy;tial pub&shy;lic … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The tally of biotechs waiting to list in the coming weeks has increased to three, after biologics maker Attovia Therapeutics filed for an initial public offering on Tuesday after the market closed.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Attovia files for IPO to take on Sanofi and Regeneron’s Dupixent

Attovia Therapeutics has filed for an IPO to secure funding for assets including a potential challenger to Sanofi and Regeneron’s Dupixent and Galderma’s Nemluvio.

TL;DR: Attovia Therapeutics has filed for an IPO to secure funding for assets including a potential challenger to Sanofi and Regeneron’s Dupixent and Galderma’s Nemluvio.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

AstraZeneca Licenses Global Rights to Dizal Lung Cancer Drug for Up-to-$1.5B

Dizal has been pursuing approvals from the FDA and China’s Center for Drug Evaluation (CDE) for a new indication for Zegfrovy, as a first-line treatment for NSCLC with exon 20 insertion EGFR mutations. The post AstraZeneca Licenses Global Rights to Dizal Lung Cancer Drug for Up-to-$1.5B appeared first on GEN - Genetic Engineering and Biotechnology News .

More: AstraZeneca Licenses Global Rights to Dizal Lung Cancer Drug for Up-to-$1.5B. Dizal has been pursuing approvals from the FDA and China’s Center for Drug Evaluation (CDE) for a new indication for Zegfrovy, as a first-line treatment for NSCLC with exon 20 insertion EGFR mutations. The post AstraZeneca Licenses Global Rights to Dizal Lung Cancer Drug for Up-to-$1.
TL;DR: The post AstraZeneca Licenses Global Rights to Dizal Lung Cancer Drug for Up-to-$1.5B appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Tick-Borne Nairoviruses Use OTU Proteases to Evade Human Antiviral Signals

Beyond familiar tick‑borne diseases, nairoviruses are quietly rising. New biochemical and structural work shows how their OTU proteases strip immune‑signaling tags, offering a foundation for biosurveillance as human infections continue to emerge. The post Tick-Borne Nairoviruses Use OTU Proteases to Evade Human Antiviral Signals appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Beyond familiar tick‑borne diseases, nairoviruses are quietly rising. New biochemical and structural work shows how their OTU proteases strip immune‑signaling tags, offering a foundation for biosurveillance as human infections continue to emerge.
TL;DR: The post Tick-Borne Nairoviruses Use OTU Proteases to Evade Human Antiviral Signals appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Celcuity wins approval for breast cancer drug Revtorpyk

A small public biotech won approval for a breast cancer drug that was designed to improve on similar treatments from Novartis and Roche. The FDA on Tuesday cleared Celcuity's Revtorpyk in combination with fulvestrant, with ...

More: Celcuity wins approval for breast cancer drug Revtorpyk. A small public biotech won approval for a breast cancer drug that was designed to improve on similar treatments from Novartis and Roche. The FDA on Tuesday cleared Celcuity's Revtorpyk in combination with fulvestrant, with ...
TL;DR: A small public biotech won approval for a breast cancer drug that was designed to improve on similar treatments from Novartis and Roche.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

With FDA approval for its breast cancer blockbuster hopeful, Celcuity could ‘belong in the hands’ of a Big Pharma

The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard-of-care for patients with breast cancer.

TL;DR: The FDA has approved a new small molecule inhibitor from Celcuity with blockbuster potential that could become a new standard-of-care for patients with breast cancer.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Protein Design’s AI Revolution: Inside David Baker’s “Communal Brain”

A Nobel laureate’s decades-long commitment to open science is reshaping biotechnology in the AI era. Deep learning methods can now design novel proteins across pharmaceuticals, vaccines, biosensors, and more. The post Protein Design’s AI Revolution: Inside David Baker’s “Communal Brain” appeared first on GEN - Genetic Engineering and Biotechnology News .

More: A Nobel laureate’s decades-long commitment to open science is reshaping biotechnology in the AI era. Deep learning methods can now design novel proteins across pharmaceuticals, vaccines, biosensors, and more. The post Protein Design’s AI Revolution: Inside David Baker’s “Communal Brain” appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Protein Design’s AI Revolution: Inside David Baker’s “Communal Brain” appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Post-Hoc Live: What’s making biotech IPOs work again?

Late last year, I found myself talking a lot about what it would take for biotech’s budding rally to become a full one. We had deals, good pipeline readouts and a rising public stock market ...

More: Post-Hoc Live: What’s making biotech IPOs work again?. Late last year, I found myself talking a lot about what it would take for biotech’s budding rally to become a full one. We had deals, good pipeline readouts and a rising public stock market ...
TL;DR: Late last year, I found myself talking a lot about what it would take for biotech’s budding rally to become a full one.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

FDA plans to release more drug rejection letters as controversial policy resumes

After pausing a controversial policy to publicly release drug rejection letters in April, the FDA today confirmed that the pause has been lifted and that more documents will be coming down the line.

TL;DR: After pausing a controversial policy to publicly release drug rejection letters in April, the FDA today confirmed that the pause has been lifted and that more documents will be coming down the line.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Biogen defends anti-tau drug after stock slides on Alzheimer’s readout

Biogen leaders took to an investor call today to defend the phase 2 readout of the company’s anti-tau Alzheimer’s disease candidate, which despite slowing cognitive decline on par with approved medicines sparked a significant stock slip.

TL;DR: Biogen leaders took to an investor call today to defend the phase 2 readout of the company’s anti-tau Alzheimer’s disease candidate, which despite slowing cognitive decline on par with approved medicines sparked a significant stock slip.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Honoring the Innovators Driving AI’s Next Era in Life Sciences and Healthcare

AI Discovery Awards exist to accelerate momentum and connect the most promising teams with compute resources, investor networks, and mentorship needed to move from promising research to bringing products to market. The post Honoring the Innovators Driving AI’s Next Era in Life Sciences and Healthcare appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Honoring the Innovators Driving AI’s Next Era in Life Sciences and Healthcare. AI Discovery Awards exist to accelerate momentum and connect the most promising teams with compute resources, investor networks, and mentorship needed to move from promising research to bringing products to market.
TL;DR: The post Honoring the Innovators Driving AI’s Next Era in Life Sciences and Healthcare appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

CEPI-backed Ebola vaccine set to enter phase 1 trials

Jul 14, 2026 12:18pm Ebola CEPI Research The first vaccine against the Bundibugyo ebola virus is poised to enter phase 1 clinical trial .  The trial will be conducted in the U.K.

More: Jul 14, 2026 12:18pm Ebola CEPI Research The first vaccine against the Bundibugyo ebola virus is poised to enter phase 1 clinical trial .  The trial will be conducted in the U.K. The ChAdOx1 BDBV vaccine was developed by the University of Oxford’s Oxford Vaccine Group in collaboration with the Serum Institute of India using the same platform as the AstraZeneca COVID-19 vaccine.
TL;DR: The first vaccine against the Bundibugyo ebola virus is poised to enter phase 1 clinical trial.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

Erasca's $550M offering; Summit sells an antibiotic

Plus, news about subcutaneous Leqembi, WuXi AppTec and Q32 Bio. 📊 Erasca targets $550M for KRAS drugs: The biotech's public offering came after it shared a small ...

More: Erasca's $550M offering; Summit sells an antibiotic. Plus, news about subcutaneous Leqembi, WuXi AppTec and Q32 Bio. 📊 Erasca targets $550M for KRAS drugs: The biotech's public offering came after it shared a small ...
TL;DR: Plus, news about subcutaneous Leqembi, WuXi AppTec and Q32 Bio.
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Chai Discovery gets $400M, tripling valuation from seven months ago

Chai Discovery, one of the hottest startups in the AI-generated drug discovery landscape, has corralled $400 million in a Series C that triples its paper value from its last round of financing. In December, Chai ...

More: Chai Dis&shy;cov&shy;ery, one of the hottest star&shy;tups in the AI-gen&shy;er&shy;at&shy;ed drug dis&shy;cov&shy;ery land&shy;scape, has cor&shy;ralled $400 mil&shy;lion in a Se&shy;ries C that triples its pa&shy;per … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Chai Discovery, one of the hottest startups in the AI-generated drug discovery landscape, has corralled $400 million in a Series C that triples its paper value from its last round of financing.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Novel Epigenetic Therapy Targets Treatment-Resistant and TP53-Mutant AML

The results of a preclinical study across multiple models of acute myeloid leukemia found that the investigational hypomethylating agent, NTX-301 remained effective in treatment-resistant AML and TP53-mutant AML through activating the Hippo pathway. The post Novel Epigenetic Therapy Targets Treatment-Resistant and TP53-Mutant AML appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Novel Epigenetic Therapy Targets Treatment-Resistant and TP53-Mutant AML. The results of a preclinical study across multiple models of acute myeloid leukemia found that the investigational hypomethylating agent, NTX-301 remained effective in treatment-resistant AML and TP53-mutant AML through activating the Hippo pathway.
TL;DR: The post Novel Epigenetic Therapy Targets Treatment-Resistant and TP53-Mutant AML appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Chai brews up $400M series C to fuel AI molecule models used by Lilly, Novartis and Pfizer

Chai Discovery has continued its whirlwind emergence, closing its third financing round in 11 months to bring its total funding haul above $600 million. The latest round values the startup at $3.8 billion.

More: Chai brews up $400M series C to fuel AI molecule models used by Lilly, Novartis and Pfizer. Chai Discovery has continued its whirlwind emergence, closing its third financing round in 11 months to bring its total funding haul above $600 million. The latest round values the startup at $3.8 billion.
TL;DR: Chai Discovery has continued its whirlwind emergence, closing its third financing round in 11 months to bring its total funding haul above $600 million.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Biogen's tau drug reports mixed Alzheimer's results, as low dose performs better

LONDON — Biogen's attempt to treat Alzheimer's by going after a protein that forms toxic tangles in the brain showed some of the strongest proof yet that it could slow dementia. But the results were marred ...

More: LON&shy;DON — Bio&shy;gen’s at&shy;tempt to treat Alzheimer’s by go&shy;ing af&shy;ter a pro&shy;tein that forms tox&shy;ic tan&shy;gles in the brain showed some of the strongest proof yet … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: LONDON — Biogen's attempt to treat Alzheimer's by going after a protein that forms toxic tangles in the brain showed some of the strongest proof yet that it could slow dementia.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Summit sells failed antibiotic to OpenAI-backed startup in $105M deal

Summit Therapeutics has cleared out an asset from its pre-ivonescimab history, offloading the antibiotic drug candidate ridinilazole to the OpenAI-backed startup Biossil for $500,000 upfront.

TL;DR: Summit Therapeutics has cleared out an asset from its pre-ivonescimab history, offloading the antibiotic drug candidate ridinilazole to the OpenAI-backed startup Biossil for $500,000 upfront.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

AAIC: Biogen bolsters hopes for Alzheimer's pivotal push as anti-tau oligo slows cognitive decline

Biogen's leading tau-targeting candidate has slowed cognitive decline across a suite of different clinical assessments, backing up the pharma’s decision to race the molecule into phase 3 development.

TL;DR: Biogen's leading tau-targeting candidate has slowed cognitive decline across a suite of different clinical assessments, backing up the pharma’s decision to race the molecule into phase 3 development.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Over half of clinical trial sites see recruitment hindered by inefficiencies: survey

A total of 59% of clinical trial sites are seeing fewer eligible patients recruited due to inefficiencies with their recruitment process, according to a recent survey

TL;DR: A total of 59% of clinical trial sites are seeing fewer eligible patients recruited due to inefficiencies with their recruitment process, according to a recent survey
Read original at Fiercebiotech
Further reading: Genome.govPubMedBioTech PrimerWikipedia

FDA Issues Proposal to Streamline Registration for Advanced Distributed Manufacturers

Distributed manufacturing establishments operate a hub-and-spoke model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Regulations require each manufacturing unit in the network to register separately. The post FDA Issues Proposal to Streamline Registration for Advanced Distributed Manufacturers appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Distributed manufacturing establishments operate a hub-and-spoke model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Regulations require each manufacturing unit in the network to register separately.
TL;DR: The post FDA Issues Proposal to Streamline Registration for Advanced Distributed Manufacturers appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Cellares and Sonoma Biotherapeutics Agree to Automate Engineered Treg Cell Therapy Manufacturing

Cellares plans to translate the manufacturing of SonomaBio’s SBT-77-7101 onto its Cell Shuttle and automate in-process and release testing through the Cell Q quality control system. The post Cellares and Sonoma Biotherapeutics Agree to Automate Engineered Treg Cell Therapy Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Cellares and Sonoma Biotherapeutics Agree to Automate Engineered Treg Cell Therapy Manufacturing. Cellares plans to translate the manufacturing of SonomaBio’s SBT-77-7101 onto its Cell Shuttle and automate in-process and release testing through the Cell Q quality control system.
TL;DR: The post Cellares and Sonoma Biotherapeutics Agree to Automate Engineered Treg Cell Therapy Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Draig nets $65M to advance depression drug aimed at rebuilding synapses

Draig Therapeutics has secured $65 million in an oversubscribed Series B raise to advance a pipeline of neuropsychiatry drugs, including its lead depression program designed to modulate the AMPA receptor. The ...

More: Draig Ther&shy;a&shy;peu&shy;tics has se&shy;cured $65 mil&shy;lion in an over&shy;sub&shy;scribed Se&shy;ries B raise to ad&shy;vance a pipeline of neu&shy;ropsy&shy;chi&shy;a&shy;try drugs, in&shy;clud&shy;ing its … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Draig Therapeutics has secured $65 million in an oversubscribed Series B raise to advance a pipeline of neuropsychiatry drugs, including its lead depression program designed to modulate the AMPA receptor.
Read original at Endpoints
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Genetic medicine startup Lyora launches with programs from Editas, Biogen

Lyora Therapeutics will try to revive several early-stage genetic eye disease programs previously held by Editas Medicine and Biogen. The biotech was co-founded by Luk Vandenberghe and Eric Pierce, both from Harvard Medical School and ...

More: Genetic medicine startup Lyora launches with programs from Editas, Biogen. Lyora Therapeutics will try to revive several early-stage genetic eye disease programs previously held by Editas Medicine and Biogen. The biotech was co-founded by Luk Vandenberghe and Eric Pierce, both from Harvard Medical School and ...
TL;DR: Lyora Therapeutics will try to revive several early-stage genetic eye disease programs previously held by Editas Medicine and Biogen.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

AstraZeneca to take rights to Dizal's lung cancer pill Zegfrovy

AstraZeneca is set to pay Dizal Pharmaceutical, which it part-owns, $600 million upfront for worldwide development and sales rights to the lung cancer drug Zegfrovy. The UK pharma said Tuesday that ...

More: AstraZeneca is set to pay Dizal Pharmaceutical, which it part-owns, $600 million upfront for worldwide development and sales rights to the lung cancer drug Zegfrovy. The UK pharma said Tuesday that ...
TL;DR: AstraZeneca is set to pay Dizal Pharmaceutical, which it part-owns, $600 million upfront for worldwide development and sales rights to the lung cancer drug Zegfrovy.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

In latest deal, Innovent seeds Spero's future beyond GSK-owned antibiotic

After partnering with four of the largest pharmaceutical companies over the past 18 months, Innovent Biologics is turning to a smaller partner for its next bet. An autoimmune drug candidate from the Suzhou, China-based biopharma ...

More: In latest deal, Innovent seeds Spero's future beyond GSK-owned antibiotic. After partnering with four of the largest pharmaceutical companies over the past 18 months, Innovent Biologics is turning to a smaller partner for its next bet. An autoimmune drug candidate from the Suzhou, China-based biopharma ...
TL;DR: After partnering with four of the largest pharmaceutical companies over the past 18 months, Innovent Biologics is turning to a smaller partner for its next bet.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Former Akero team announces new I&I company, Avere, with China drug

Everything around China biotech really does seem to be speeding up. On Tuesday, the former executive team behind Akero Therapeutics unveiled a new company, a pipeline drug from China and a reverse merger to go ...

More: Former Akero team announces new I&I company, Avere, with China drug. Everything around China biotech really does seem to be speeding up. On Tuesday, the former executive team behind Akero Therapeutics unveiled a new company, a pipeline drug from China and a reverse merger to go ...
TL;DR: Everything around China biotech really does seem to be speeding up.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Avere goes public via NextCure reverse merger, secures Hansoh IL-23 drug with $2.3B deal

Avere Therapeutics has burst onto the scene by securing a public listing via a reverse merger with NextCure, while stocking a pipeline with an IL-23 drug from Hansoh Pharmaceutical.

More: The combined company, which will list on the Nasdaq under the ticker “AVRX,” will be led by Avere's CEO Andrew Cheng, M.D., Ph.D. The Avere team was introduced to NextCure by wealth management firm Wedbush Securities, Cheng told Fierce, adding that the brittle bone disease biotech was an ideal partner because of its Nasdaq listing and “full support for our go-forward vision of…
TL;DR: Avere Therapeutics has burst onto the scene by securing a public listing via a reverse merger with NextCure, while stocking a pipeline with an IL-23 drug from Hansoh Pharmaceutical.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Spero pivots to I&I with $1.1B deal for Innovent antibody, sells slice of Utebzi royalties for $105M

Spero Therapeutics is pivoting to immune and inflammation indications through a license agreement for a CD40L antibody with Innovent Biologics in a deal worth up to $1.1 billion.

More: Innovent has previously evaluated SP001, formerly known as IBI355, in a pair of phase 1 trials involving healthy volunteers as well as a phase 1b study of patients with Sjögren’s disease, an autoimmune disease in which the patient’s immune system attacks the tear and salivary glands, leading to dry eyes and mouth.
TL;DR: Spero Therapeutics is pivoting to immune and inflammation indications through a license agreement for a CD40L antibody with Innovent Biologics in a deal worth up to $1.1 billion.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Genome-Scale CRISPRi Atlas Maps Gene Function Across Human iPSCs

A new genome-scale atlas is offering an unprecedented look at how individual genes shape the transcriptional landscape of human induced pluripotent stem cells (iPSCs).

More: Genome-Scale CRISPRi Atlas Maps Gene Function Across Human iPSCs. Published in Nature Biotechnology , the resource catalogs the effects of perturbing 11,692 expressed genes across more than 2.5 million single cells, creating a reference framework for understanding how pluripotent identity is maintained and regulated.
TL;DR: A new genome-scale atlas is offering an unprecedented look at how individual genes shape the transcriptional landscape of human induced pluripotent stem cells (iPSCs).
Read original at Genengnews
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Analytical Challenges for Antibody-Drug Conjugate (ADC) Manufacturing

This collection of articles and expert perspectives explores the critical challenges shaping ADC development today, from analytical strategy and impurity control to linker technology innovations and evolving regulatory standards. It also examines the collaborative expertise needed to bring these transformative therapies to patients. The post Analytical Challenges for Antibody-Drug Conjugate (ADC) Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .

More: This collection of articles and expert perspectives explores the critical challenges shaping ADC development today, from analytical strategy and impurity control to linker technology innovations and evolving regulatory standards. It also examines the collaborative expertise needed to bring these transformative therapies to patients.
TL;DR: The post Analytical Challenges for Antibody-Drug Conjugate (ADC) Manufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

New Lung Model Reveals RSV Immune Response, Points to Better Treatments

Researchers used pediatric airway cells, blood vessel cells, and neutrophils to build an in vitro model of infant lungs that allowed them to investigate why respiratory syncytial virus makes infants sicker than adults, and to test new treatments. The post New Lung Model Reveals RSV Immune Response, Points to Better Treatments appeared first on GEN - Genetic Engineering and Biotechnology News .

More: New Lung Model Reveals RSV Immune Response, Points to Better Treatments. Researchers used pediatric airway cells, blood vessel cells, and neutrophils to build an in vitro model of infant lungs that allowed them to investigate why respiratory syncytial virus makes infants sicker than adults, and to test new treatments.
TL;DR: The post New Lung Model Reveals RSV Immune Response, Points to Better Treatments appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

FDA finalizes guidance on psychedelics, plans broader hearing

The FDA has finalized clinical guidance for psychedelic drug developers and has scheduled a public hearing on future therapeutic use, adding regulatory momentum to a class on the precipice of approval. The

More: The FDA has fi&shy;nal&shy;ized clin&shy;i&shy;cal guid&shy;ance for psy&shy;che&shy;del&shy;ic drug de&shy;vel&shy;op&shy;ers and has sched&shy;uled a pub&shy;lic hear&shy;ing on fu&shy;ture ther&shy;a&shy;peu&shy;tic use, adding reg&shy;u&shy;la&shy;to&shy;ry mo&shy;men&shy;tum to a … Get free access to a limited number of articles, plus choose newsletters to get straight to…
TL;DR: The FDA has finalized clinical guidance for psychedelic drug developers and has scheduled a public hearing on future therapeutic use, adding regulatory momentum to a class on the precipice of approval.
Read original at Endpoints
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Mung Bean Pan-Genome Study Maps Key Genes for Yield, Nutrition, and Pest Resistance

Researchers have created the world's first graph-based mung bean pan-genome, revealing genetic variations linked to yield, nutrition, and pest resistance, and providing breeders with powerful tools to accelerate crop improvement and strengthen food security. The post Mung Bean Pan-Genome Study Maps Key Genes for Yield, Nutrition, and Pest Resistance appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Mung Bean Pan-Genome Study Maps Key Genes for Yield, Nutrition, and Pest Resistance. Researchers have created the world's first graph-based mung bean pan-genome, revealing genetic variations linked to yield, nutrition, and pest resistance, and providing breeders with powerful tools to accelerate crop improvement and strengthen food security.
TL;DR: The post Mung Bean Pan-Genome Study Maps Key Genes for Yield, Nutrition, and Pest Resistance appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

FDA proposes rule to simplify drugmakers' factory registrations

The FDA is proposing a rule to change how factories are registered with the agency if they are making products for the US market, as part of a continuing effort to try to speed up ...

More: The FDA is propos&shy;ing a rule to change how fac&shy;to&shy;ries are reg&shy;is&shy;tered with the agency if they are mak&shy;ing prod&shy;ucts for the US mar&shy;ket, as … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA is proposing a rule to change how factories are registered with the agency if they are making products for the US market, as part of a continuing effort to try to speed up ...
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Health tech funding rises to $7.4B in the first half of 2026

Digital health startups raised $7.4 billion in venture funding during the first half of 2026, up $1 billion from the first half of 2025, according to research and venture firm Rock Health. Megarounds of $100 ...

More: Dig&shy;i&shy;tal health star&shy;tups raised $7.4 bil&shy;lion in ven&shy;ture fund&shy;ing dur&shy;ing the first half of 2026, up $1 bil&shy;lion from the first half of 2025, ac&shy;cord&shy;ing … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Digital health startups raised $7.4 billion in venture funding during the first half of 2026, up $1 billion from the first half of 2025, according to research and venture firm Rock Health.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Tris Pharma's CRL for narcolepsy drug; Agenus abandons Phase 3 CRC trial

Plus, news about Insilico, Ipsen, Q32 Bio, GSK’s Jemperli, Drug Farm and Padcev. ❌ FDA rejects Tris Pharma’s narcolepsy drug: Its rejection letter said that “additional information will be necessary” to ...

More: Tris Pharma's CRL for narcolepsy drug; Agenus abandons Phase 3 CRC trial. Plus, news about Insilico, Ipsen, Q32 Bio, GSK’s Jemperli, Drug Farm and Padcev. ❌ FDA rejects Tris Pharma’s narcolepsy drug: Its rejection letter said that “additional information will be necessary” to ...
TL;DR: Plus, news about Insilico, Ipsen, Q32 Bio, GSK’s Jemperli, Drug Farm and Padcev.
Read original at Endpoints
Further reading: PubMedGenome.govBioTech PrimerWikipedia

FDA releases 14 new drug rejection letters after 3-month pause in transparency policy

The FDA has published 14 new rejection letters for drug applications, mere days after confirming to Fierce that a policy of releasing the documents had been paused in April.

TL;DR: The FDA has published 14 new rejection letters for drug applications, mere days after confirming to Fierce that a policy of releasing the documents had been paused in April.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Q32’s stock jumps 60% on latest phase 2 alopecia data for potential rival to JAK inhibitors

The latest phase 2 readout for Q32 Bio’s alopecia hopeful received a warm reception from investors, supporting the biotech’s case that the drug could offer a more durable alternative to JAK inhibitors.

TL;DR: The latest phase 2 readout for Q32 Bio’s alopecia hopeful received a warm reception from investors, supporting the biotech’s case that the drug could offer a more durable alternative to JAK inhibitors.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Immune Evasion Uncovered by Virome-Wide Ubiquitin Ligase Discovery

Viruses hijack cells’ garbage-disposal systems to evade immune attack. The study proposes to speed basic discoveries in virology, and inform the development of new vaccines and treatments to protect against emerging pathogens.  The post Immune Evasion Uncovered by Virome-Wide Ubiquitin Ligase Discovery appeared first on GEN - Genetic Engineering and Biotechnology News .

More:   The study applies  ORFeome , a tool that broadens the scale by which researchers study viral proteins. Previous viral ORF libraries from other groups focused on individual viruses or virus families that contained 100 or 200 sequences each.
TL;DR: Viruses hijack cells’ garbage-disposal systems to evade immune attack. The study proposes to speed basic discoveries in virology, and inform the development of new vaccines and treatments to protect against emerging pathogens.  The post Immune Evasion Uncovered by Virome-Wide Ubiquitin Ligase Discovery appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Genetic Map Opens Door to Development of New Therapies to Reverse Bone Loss

The international team of scientists identified hundreds of previously unknown genes that govern bone health and revealed cells surrounding blood vessels as one of the drivers of bone repair. The post Genetic Map Opens Door to Development of New Therapies to Reverse Bone Loss appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Genetic Map Opens Door to Development of New Therapies to Reverse Bone Loss. The international team of scientists identified hundreds of previously unknown genes that govern bone health and revealed cells surrounding blood vessels as one of the drivers of bone repair.
TL;DR: The post Genetic Map Opens Door to Development of New Therapies to Reverse Bone Loss appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Agenus scraps phase 3 colorectal study after 3 months to narrow focus to colon cancer

Agenus has scrapped a phase 3 study of its combo therapy in colorectal cancer after just three months in order to go all-in on colon cancer.

TL;DR: Agenus has scrapped a phase 3 study of its combo therapy in colorectal cancer after just three months in order to go all-in on colon cancer.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

Apnimed dreams of IPO to fund launch of sleep apnea pill on FDA's desk

Apnimed is having sweet dreams of an IPO that could fund the planned commercial launch of an obstructive sleep apnea therapy that is currently awaiting an FDA approval decision.

TL;DR: Apnimed is having sweet dreams of an IPO that could fund the planned commercial launch of an obstructive sleep apnea therapy that is currently awaiting an FDA approval decision.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

StockWatch: Insilico Projects Profit, Revenue Leaps as AI-Developed Lead Candidate Moves to Phase III

Insilico Medicine, an AI-based drug developer whose profile within biopharma has risen with its recent collaborations with industry giants, has offered investors an upbeat revenue and profit forecast for the first half of 2026, driven by its series of partnerships and a wide-ranging pipeline whose first program has reached late-stage development this past week. The post StockWatch: Insilico Projects Profit, Revenue Leaps as AI-Developed Lead Candidate Moves to Phase III appeared first on GEN - Genetic Engineering and Biotechnology News .

More: StockWatch: Insilico Projects Profit, Revenue Leaps as AI-Developed Lead Candidate Moves to Phase III. Insilico Medicine, an AI-based drug developer whose profile within biopharma has risen with its recent collaborations with industry giants, has offered investors an upbeat revenue and profit forecast for the first half of 2026, driven by its series of partnerships and a wide-…
TL;DR: The post StockWatch: Insilico Projects Profit, Revenue Leaps as AI-Developed Lead Candidate Moves to Phase III appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

‘How did they get there first?’ Biotechs forced to learn new patent tricks to protect pipelines

For a biotech, your intellectual property is your most prized asset. But a new era of increased global competition means that strong patents, longer stealth periods and even some misdirection can be required to ensure drug developers retain an edge.

More: ‘How did they get there first?’ Biotechs forced to learn new patent tricks to protect pipelines. For a biotech, your intellectual property is your most prized asset. But a new era of increased global competition means that strong patents, longer stealth periods and even some misdirection can be required to ensure drug developers retain an edge.
TL;DR: For a biotech, your intellectual property is your most prized asset.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

IHealthScreen nabs FDA nod for AI-backed dx to spot mild diabetic retinopathy

IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.

TL;DR: IHealthScreen hauled in FDA 510(k) clearance for its AI-powered diagnostic that detects mild diabetic retinopathy in diabetic adults who have gone undiagnosed with the condition.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Deals, deals, deals; Biohaven takes on Eli Lilly; and more

Welcome back to Endpoints Weekly! Don’t miss Ryan Cross’ deep dive into the paranoia caused by competition with China. Ryan writes that US biotech companies are holding their cards close to the ...

More: Deals, deals, deals; Biohaven takes on Eli Lilly; and more. Welcome back to Endpoints Weekly! Don’t miss Ryan Cross’ deep dive into the paranoia caused by competition with China.
TL;DR: Ryan writes that US biotech companies are holding their cards close to the ...
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Fierce Biotech Fundraising Tracker '26: MindRank rakes in $52M to advance phase 3-stage oral GLP-1

The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs.

More: Fierce Biotech Fundraising Tracker '26: MindRank rakes in $52M to advance phase 3-stage oral GLP-1. The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs.
TL;DR: The Fierce Biotech Fundraising Tracker records venture capital rounds of $50 million or more secured by biotechs.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Apnimed files for IPO as FDA reviews its sleep apnea drug

Apnimed is finally going forward with an IPO attempt after years of flirting with the milestone. The Cambridge, MA-based biotech revealed its Nasdaq plans on Friday night, following a strong six ...

More: Apnimed files for IPO as FDA reviews its sleep apnea drug. Apnimed is finally going forward with an IPO attempt after years of flirting with the milestone. The Cambridge, MA-based biotech revealed its Nasdaq plans on Friday night, following a strong six ...
TL;DR: Apnimed is finally going forward with an IPO attempt after years of flirting with the milestone.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

FDA returns to releasing pharma rejection letters with 14 new CRLs

The FDA on Friday posted 14 new rejection letters to pharma companies online, days after HHS confirmed to Endpoints News that the agency had paused new CRL releases because of a pharma-backed ...

More: The FDA on Fri&shy;day post&shy;ed 14 new re&shy;jec&shy;tion let&shy;ters to phar&shy;ma com&shy;pa&shy;nies on&shy;line, days af&shy;ter HHS con&shy;firmed to End&shy;points News that the … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA on Friday posted 14 new rejection letters to pharma companies online, days after HHS confirmed to Endpoints News that the agency had paused new CRL releases because of a pharma-backed ...
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

FDA rejects Hengrui-Elevar liver cancer drug combo for third time

For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat the most common form of liver ...

More: For the third time in about two years, the FDA has cit&shy;ed man&shy;u&shy;fac&shy;tur&shy;ing de&shy;fi&shy;cien&shy;cies in re&shy;ject&shy;ing a drug com&shy;bi&shy;na&shy;tion from Jiang&shy;su Hen&shy;grui Phar&shy;ma&shy;ceu&shy;ti&shy;cals and El&shy;e&shy;var … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat the most common form of liver ...
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

FDA adds 100+ new CDER employees in a quarter for first time since late 2024

The FDA's drug center hired more new employees than it lost in a quarter for the first time since the Trump administration gutted the agency's ranks in April 2025. The FDA's

More: The FDA’s drug cen&shy;ter hired more new em&shy;ploy&shy;ees than it lost in a quar&shy;ter for the first time since the Trump ad&shy;min&shy;is&shy;tra&shy;tion gut&shy;ted the agency’s … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA's drug center hired more new employees than it lost in a quarter for the first time since the Trump administration gutted the agency's ranks in April 2025.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Macrophage Membrane-Derived Nanoparticles Shows Potential Against Candida Infections

By coating biodegradable nanoparticles with macrophage membranes, scientists developed a targeted antifungal delivery platform that increased drug accumulation at infection sites and improved treatment efficacy in preclinical studies. The post Macrophage Membrane-Derived Nanoparticles Shows Potential Against <i>Candida</i> Infections appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Macrophage Membrane-Derived Nanoparticles Shows Potential Against Candida Infections. By coating biodegradable nanoparticles with macrophage membranes, scientists developed a targeted antifungal delivery platform that increased drug accumulation at infection sites and improved treatment efficacy in preclinical studies.
TL;DR: The post Macrophage Membrane-Derived Nanoparticles Shows Potential Against <i>Candida</i> Infections appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

US biotechs turn secretive as they fear competition from rising Chinese industry

Janine Sengstack believes she may have found the next big breakthrough in diabetes and obesity. Her company, Junevity, has searched through hundreds of genes to discover ones that, when repressed, can turn ...

More: US biotechs turn secretive as they fear competition from rising Chinese industry. Janine Sengstack believes she may have found the next big breakthrough in diabetes and obesity. Her company, Junevity, has searched through hundreds of genes to discover ones that, when repressed, can turn ...
TL;DR: Janine Sengstack believes she may have found the next big breakthrough in diabetes and obesity.
Read original at Endpoints
Further reading: Genome.govNature BiotechBioTech PrimerWikipedia

Hansoh meets Phase 3 SCLC goal; FDA approves Sanofi on-body injector

Plus, news about Huntington's, Fate Therapeutics and Bausch + Lomb. 🇨🇳 Hansoh touts Phase 3 success for GSK-partnered ADC: The program, called risvutatug rezetecan or Ris-Rez, met its primary endpoint of overall ...

More: Hansoh meets Phase 3 SCLC goal; FDA approves Sanofi on-body injector. Plus, news about Huntington's, Fate Therapeutics and Bausch + Lomb. 🇨🇳 Hansoh touts Phase 3 success for GSK-partnered ADC: The program, called risvutatug rezetecan or Ris-Rez, met its primary endpoint of overall ...
TL;DR: Plus, news about Huntington's, Fate Therapeutics and Bausch + Lomb.
Read original at Endpoints
Further reading: Genome.govNature BiotechBioTech PrimerWikipedia

GSK sees phase 3 win for Hansoh-partnered ADC in China as validating its ‘priority asset’

Hansoh Pharmaceutical’s pair of much-hyped ADCs continue to justify partner GSK’s decision to make them priority programs.

More: GSK sees phase 3 win for Hansoh-partnered ADC in China as validating its ‘priority asset’. Hansoh Pharmaceutical’s pair of much-hyped ADCs continue to justify partner GSK’s decision to make them priority programs.
TL;DR: Hansoh Pharmaceutical’s pair of much-hyped ADCs continue to justify partner GSK’s decision to make them priority programs.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

The data that led Cellular Intelligence to pick up Novo's Parkinson's stem cell therapy

MONTREAL — After Novo Nordisk closed its cell therapy unit, Cellular Intelligence contracted neurologist and drug developer Nuno Mendonça to conduct due diligence on the Danish pharma’s Parkinson’s cell therapy program. Mendonça said, “He'll do it ...

More: MON&shy;TRE&shy;AL — Af&shy;ter No&shy;vo Nordisk closed its cell ther&shy;a&shy;py unit, Cel&shy;lu&shy;lar In&shy;tel&shy;li&shy;gence con&shy;tract&shy;ed neu&shy;rol&shy;o&shy;gist and drug de&shy;vel&shy;op&shy;er Nuno Men&shy;donça to con&shy;duct due dili&shy;gence on the Dan&shy;ish … Get free access to a limited number of articles, plus choose newsletters to get strai…
TL;DR: MONTREAL — After Novo Nordisk closed its cell therapy unit, Cellular Intelligence contracted neurologist and drug developer Nuno Mendonça to conduct due diligence on the Danish pharma’s Parkinson’s cell therapy program.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Pfizer appoints obesity discovery head; AI startup Xaira makes leadership adjustments

→ Danna Breen has been promoted to head of obesity discovery at Pfizer, according to a LinkedIn post. Breen succeeds Kendra Bence and gets this opportunity after nearly 14 years with ...

More: Pfizer appoints obesity discovery head; AI startup Xaira makes leadership adjustments. → Danna Breen has been promoted to head of obesity discovery at Pfizer, according to a LinkedIn post. Breen succeeds Kendra Bence and gets this opportunity after nearly 14 years with ...
TL;DR: → Danna Breen has been promoted to head of obesity discovery at Pfizer, according to a LinkedIn post.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Bausch + Lomb gives up on glaucoma eye drop hopeful after phase 2 fail

Bausch + Lomb has abandoned its next great hope in glaucoma after the eye drops flunked a phase 2 study.

TL;DR: Bausch + Lomb has abandoned its next great hope in glaucoma after the eye drops flunked a phase 2 study.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

ARPA-H awards up to $160M to scientists developing custom genetic medicines

The Advanced Research Projects Agency for Health has awarded a new tranche of funds for companies and institutions developing personalized genetic medicines, with the recipient list dominated by high-profile players in the buzzy field.

TL;DR: The Advanced Research Projects Agency for Health has awarded a new tranche of funds for companies and institutions developing personalized genetic medicines, with the recipient list dominated by high-profile players in the buzzy field.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Epigenomic Analysis Uncovers New AML Subgroups and Drug Sensitivities

New chromatin‑based analysis of 1,563 AML samples reveals 16 epigenomic subgroups that improve prognostic accuracy and highlight unexpected drug sensitivities. The post Epigenomic Analysis Uncovers New AML Subgroups and Drug Sensitivities appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Epigenomic Analysis Uncovers New AML Subgroups and Drug Sensitivities. New chromatin‑based analysis of 1,563 AML samples reveals 16 epigenomic subgroups that improve prognostic accuracy and highlight unexpected drug sensitivities. The post Epigenomic Analysis Uncovers New AML Subgroups and Drug Sensitivities appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Epigenomic Analysis Uncovers New AML Subgroups and Drug Sensitivities appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Stem Cell Therapy Shows Promise in First Human Parkinson’s Disease Trial

One year findings from Phase I/II clinical study support the feasibility of transplanting stem-cell derived dopamine progenitor cells into the brain of Parkinson’s disease patients. The post Stem Cell Therapy Shows Promise in First Human Parkinson’s Disease Trial appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Stem Cell Therapy Shows Promise in First Human Parkinson’s Disease Trial. One year findings from Phase I/II clinical study support the feasibility of transplanting stem-cell derived dopamine progenitor cells into the brain of Parkinson’s disease patients.
TL;DR: The post Stem Cell Therapy Shows Promise in First Human Parkinson’s Disease Trial appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

ARPA-H bookmarks $160M for custom gene editing treatments. Is it enough?

After an infant last year was saved from a deadly disease thanks to a bespoke gene editing therapy that fixed an incredibly rare mutation in his DNA, the US government is hoping ...

More: Af&shy;ter an in&shy;fant last year was saved from a dead&shy;ly dis&shy;ease thanks to a be&shy;spoke gene edit&shy;ing ther&shy;a&shy;py that fixed an in&shy;cred&shy;i&shy;bly … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: After an infant last year was saved from a deadly disease thanks to a bespoke gene editing therapy that fixed an incredibly rare mutation in his DNA, the US government is hoping ...
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Crohn’s Disease Phage Therapy Neutralizes Inflammatory E. coli in Mouse Model

Researchers developed a supportive bacteriophage therapy for Crohn’s disease that in a mouse model neutralized a type of E. coli bacteria that drives inflammation in the gut, and improved responses to low doses of a conventional corticosteroid. The post Crohn’s Disease Phage Therapy Neutralizes Inflammatory <i>E. coli</i> in Mouse Model appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Crohn’s Disease Phage Therapy Neutralizes Inflammatory E. Researchers developed a supportive bacteriophage therapy for Crohn’s disease that in a mouse model neutralized a type of E. The post Crohn’s Disease Phage Therapy Neutralizes Inflammatory <i>E.
TL;DR: coli</i> in Mouse Model appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Engineered AAVs Harness Glymphatic System to Reach Brain Targets in Mice

By delivering engineered adeno-associated viruses through the brain's fluid transport network to target glial cells, scientists demonstrated a strategy that could bypass the blood-brain barrier and enable future brain-directed gene therapies. The post Engineered AAVs Harness Glymphatic System to Reach Brain Targets in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Engineered AAVs Harness Glymphatic System to Reach Brain Targets in Mice. By delivering engineered adeno-associated viruses through the brain's fluid transport network to target glial cells, scientists demonstrated a strategy that could bypass the blood-brain barrier and enable future brain-directed gene therapies.
TL;DR: The post Engineered AAVs Harness Glymphatic System to Reach Brain Targets in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

HHS advances plan to pay out Covid-19 vaccine injury claims

A newly proposed HHS rule would establish a compensation mechanism for people who claim they were injured by Covid-19 vaccines, as a key panel that oversees broader vaccine injury payments remains in limbo. The money ...

More: A new&shy;ly pro&shy;posed HHS rule would es&shy;tab&shy;lish a com&shy;pen&shy;sa&shy;tion mech&shy;a&shy;nism for peo&shy;ple who claim they were in&shy;jured by Covid-19 vac&shy;cines, as a key pan&shy;el that … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: A newly proposed HHS rule would establish a compensation mechanism for people who claim they were injured by Covid-19 vaccines, as a key panel that oversees broader vaccine injury payments remains in limbo.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Roche ends work on tominersen after decade of trials, as well as early-stage Huntington’s asset

After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen. The decision comes after tominersen did no better than placebo in a Phase 2 ...

More: Roche ends work on tominersen after decade of trials, as well as early-stage Huntington’s asset. After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen. The decision comes after tominersen did no better than placebo in a Phase 2 ...
TL;DR: After more than a decade of work and plenty of ups and downs, Roche has dropped its Huntington’s disease drug tominersen.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Roche ends 2 Huntington’s disease programs, including Ionis-partnered tominersen

Roche has halted development on two of its Huntington’s disease prospects, marking another blow for a patient community that has long awaited new medicines.

TL;DR: Roche has halted development on two of its Huntington’s disease prospects, marking another blow for a patient community that has long awaited new medicines.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

UK price watchdog recommends against Amgen's Lumakras in lung cancer

The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institute for Health and Care Excellence ...

More: UK price watchdog recommends against Amgen's Lumakras in lung cancer. The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients. In draft guidance released on Thursday, the National Institute for Health and Care Excellence ...
TL;DR: The UK’s drug pricing watchdog said government reimbursement of Amgen’s lung cancer drug Lumakras should be cut off for new patients.
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

FDA criticizes Lundbeck for now-deleted webpages on migraine treatment

The FDA has chastised Lundbeck Seattle Biopharmaceuticals for two promotional webpages, neither of which is still online, that made allegedly inflated claims regarding the efficacy of its migraine drug. In an

More: The FDA has chas&shy;tised Lund&shy;beck Seat&shy;tle Bio&shy;phar&shy;ma&shy;ceu&shy;ti&shy;cals for two pro&shy;mo&shy;tion&shy;al web&shy;pages, nei&shy;ther of which is still on&shy;line, that made al&shy;leged&shy;ly in&shy;flat&shy;ed claims re&shy;gard&shy;ing the ef&shy;fi&shy;ca&shy;cy … Get free access to a limited number of articles, plus choose newsletters to get s…
TL;DR: The FDA has chastised Lundbeck Seattle Biopharmaceuticals for two promotional webpages, neither of which is still online, that made allegedly inflated claims regarding the efficacy of its migraine drug.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

FDA quietly stops releasing CRLs

The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information. The pause follows a law firm in April

More: The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information. The pause follows a law firm in April
TL;DR: The FDA has paused its public release of pharma rejection letters as the agency seeks to avoid litigation around releasing the often sensitive information.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

The biggest health tech stories of 2026 — so far

We’re more than halfway through 2026, and it’s been an eventful year. Here are the five biggest developments we noticed in the first six months. Major AI companies are coming for healthcare.

More: The biggest health tech stories of 2026 — so far. Here are the five biggest developments we noticed in the first six months. Major AI companies are coming for healthcare.
TL;DR: We’re more than halfway through 2026, and it’s been an eventful year.
Read original at Endpoints
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Ipsen succeeds in migraine trials; Tarsus buys iRenix for $75M upfront

Plus news on Alchemab, Scipher and Forte. 💉 Ipsen’s Dysport aces Phase 3 migraine trials: The biotech’s injectable neurotoxin met the primary endpoint of reducing monthly migraine days in two ...

More: Ipsen succeeds in migraine trials; Tarsus buys iRenix for $75M upfront. Plus news on Alchemab, Scipher and Forte. 💉 Ipsen’s Dysport aces Phase 3 migraine trials: The biotech’s injectable neurotoxin met the primary endpoint of reducing monthly migraine days in two ...
TL;DR: Plus news on Alchemab, Scipher and Forte.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

STAT+: Prime wins Beam arbitration, clearing path to clinic

AstraZeneca, Ionis report major trial failure, White House pushes for American drug manufacturing, and more biotech news from The Readout

More: A father fights to create and then save his daughter’s gene therapy, the White House nears a decision on an FDA chief, and the Trump administration pushes drugmakers to reshore generics manufacturing.
TL;DR: AstraZeneca, Ionis report major trial failure, White House pushes for American drug manufacturing, and more biotech news from The Readout
Read original at Statnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Eli Lilly dominates first-half biotech acquisitions, with no sign of slowing down

Riding on its trillion-dollar heft and successes in treating obesity, Eli Lilly has now become a force in one area where it hasn’t historically been the main player: M&A. The Indianapolis-based drug ...

More: Rid&shy;ing on its tril&shy;lion-dol&shy;lar heft and suc&shy;cess&shy;es in treat&shy;ing obe&shy;si&shy;ty, Eli Lil&shy;ly has now be&shy;come a force in one area where it … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Riding on its trillion-dollar heft and successes in treating obesity, Eli Lilly has now become a force in one area where it hasn’t historically been the main player: M&A.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Ag Genomics Begins to Bear Fruit

Genomics tools—applied to agriculture—create commercially desirable traits in a fraction of the time required by standard breeding programs. The post Ag Genomics Begins to Bear Fruit appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Ag Genomics Begins to Bear Fruit. Genomics tools—applied to agriculture—create commercially desirable traits in a fraction of the time required by standard breeding programs. The post Ag Genomics Begins to Bear Fruit appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Ag Genomics Begins to Bear Fruit appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Catalent to divest UK site; Rottendorf, Evonik announce manufacturing builds

Plus, news about RoslinCT, Novo Nordisk and more. 🇬🇧 Catalent to sell UK site to Codis: The CDMO is set to take Catalent’s oral solid dose factory in Nottingham, with ...

More: Catalent to divest UK site; Rottendorf, Evonik announce manufacturing builds. Plus, news about RoslinCT, Novo Nordisk and more. 🇬🇧 Catalent to sell UK site to Codis: The CDMO is set to take Catalent’s oral solid dose factory in Nottingham, with ...
TL;DR: Plus, news about RoslinCT, Novo Nordisk and more.
Read original at Endpoints
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Top 10 Best-Selling Drugs 2026

Total aggregate value of the drugs generating the highest sales in 2025 jumped 21.5% vs. 2024, and more than doubled from a decade ago. The post Top 10 Best-Selling Drugs 2026 appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Total aggregate value of the drugs generating the highest sales in 2025 jumped 21.5% vs. 2024, and more than doubled from a decade ago. The post Top 10 Best-Selling Drugs 2026 appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Top 10 Best-Selling Drugs 2026 appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Fate’s off-the-shelf CAR-T therapy shows early promise in treatment-resistant autoimmune disease

“We were not expecting to see clinical responses so early,” Vaneet Sandhu, M.D., rheumatologist and vice president of clinical development at Fate Therapeutics, told Fierce.

More: Fate’s off-the-shelf CAR-T therapy shows early promise in treatment-resistant autoimmune disease. “We were not expecting to see clinical responses so early,” Vaneet Sandhu, M.D., rheumatologist and vice president of clinical development at Fate Therapeutics, told Fierce.
TL;DR: “We were not expecting to see clinical responses so early,” Vaneet Sandhu, M.D., rheumatologist and vice president of clinical development at Fate Therapeutics, told Fierce.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Virtual Cells Go Multiscale to Predict Complex Biology

As the diversity of virtual cell models targets new dimensions of complex biology, every approach takes another step closer toward clinical impact. The post Virtual Cells Go Multiscale to Predict Complex Biology appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Virtual Cells Go Multiscale to Predict Complex Biology. As the diversity of virtual cell models targets new dimensions of complex biology, every approach takes another step closer toward clinical impact. The post Virtual Cells Go Multiscale to Predict Complex Biology appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Virtual Cells Go Multiscale to Predict Complex Biology appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Why biotech revenue projections ‘won’t look as sunny’ once Trump tax bill hits Medicaid enrollment

Insurance coverage losses caused by the Trump administration's tax and spend law could make it harder for biotechs to secure funding and recruit patients for trials, experts have told Fierce.

TL;DR: Insurance coverage losses caused by the Trump administration's tax and spend law could make it harder for biotechs to secure funding and recruit patients for trials, experts have told Fierce.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Advanced Cell Sorting Balances Precision, Scale, and Simplicity

Next-generation instruments improve rare-cell detection, sterility control, biosafety, and throughput for translational applications. The post Advanced Cell Sorting Balances Precision, Scale, and Simplicity appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Advanced Cell Sorting Balances Precision, Scale, and Simplicity. Next-generation instruments improve rare-cell detection, sterility control, biosafety, and throughput for translational applications. The post Advanced Cell Sorting Balances Precision, Scale, and Simplicity appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Advanced Cell Sorting Balances Precision, Scale, and Simplicity appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Texas Biomed Enters Into a CRADA with U.S. Dept. of War to Help Protect Against Biological Threats

The CRADA framework is intended to ensure that critical resources for biological threats, whether from naturally emerging diseases or engineered risks, are ready and available on demand, rather than episodically. The post Texas Biomed Enters Into a CRADA with U.S. Dept. of War to Help Protect Against Biological Threats appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Texas Biomed Enters Into a CRADA with U.S. The post Texas Biomed Enters Into a CRADA with U.S. of War to Help Protect Against Biological Threats appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: of War to Help Protect Against Biological Threats appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Who’s going to run the FDA? 

RFK Jr.'s list of Covid vaccine injuries, a father's quest to cure his daughter, and more health news from Morning Rounds

More: Damian covers the global drug industry and contributes to STAT’s industry-leading events. Matt Wilsey has committed a decade of tireless labor and about $70 million to find a medicine for his daughter’s ultra-rare genetic condition. His next challenge — winning over a skeptical Food and Drug Administration — will reverberate throughout an entire field of medicine.
TL;DR: RFK Jr.'s list of Covid vaccine injuries, a father's quest to cure his daughter, and more health news from Morning Rounds
Read original at Statnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

GSK walks away from Alector pact as immuno-neurology bet fizzles

After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments. GSK’s exit effectively ...

More: Af&shy;ter two high-pro&shy;file tri&shy;al fail&shy;ures over the past year, GSK is break&shy;ing off a deal that fea&shy;tures $700 mil&shy;lion up&shy;front that it … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: After two high-profile trial failures over the past year, GSK is breaking off a deal that features $700 million upfront that it signed with Alector for neurodegenerative disease treatments.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

GSK cuts losses on $700M upfront Alzheimer’s collab with Alector following 2 clinical failures

GSK has walked away from a $2.2 billion biobucks neurodegenerative disease pact with Alector that has seen both “next generation” drugs involved flunk clinical trials.

TL;DR: GSK has walked away from a $2.2 billion biobucks neurodegenerative disease pact with Alector that has seen both “next generation” drugs involved flunk clinical trials.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

AstraZeneca sinks on unexpected heart drug trial failure

AstraZeneca’s shares dropped in early trading Thursday after a heart disease treatment it is developing with Ionis Pharmaceuticals unexpectedly failed in a late-stage trial. The UK company had aimed to show that its antisense drug ...

More: AstraZeneca sinks on unexpected heart drug trial failure. AstraZeneca’s shares dropped in early trading Thursday after a heart disease treatment it is developing with Ionis Pharmaceuticals unexpectedly failed in a late-stage trial. The UK company had aimed to show that its antisense drug ...
TL;DR: AstraZeneca’s shares dropped in early trading Thursday after a heart disease treatment it is developing with Ionis Pharmaceuticals unexpectedly failed in a late-stage trial.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Epitope Editing Strategy Could Enable Less Toxic Stem Cell Transplants

Researchers developed an epitope editing strategy to make donated stem cells invisible to pre-transplant antibody therapy, offering up a new approach that could make antibodies a less toxic alternative to chemotherapy for selectively clearing the patient’s existing stem cells from the bone marrow. The post Epitope Editing Strategy Could Enable Less Toxic Stem Cell Transplants appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Epitope Editing Strategy Could Enable Less Toxic Stem Cell Transplants. Researchers developed an epitope editing strategy to make donated stem cells invisible to pre-transplant antibody therapy, offering up a new approach that could make antibodies a less toxic alternative to chemotherapy for selectively clearing the patient’s existing stem cells from the bone marrow.
TL;DR: The post Epitope Editing Strategy Could Enable Less Toxic Stem Cell Transplants appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Fujifilm Selected with Six Others in FDA PreCheck Pilot Manufacturing Program

Fujifilm’s Holly Springs facility is one of North America's largest end-to-end cell culture biopharmaceutical manufacturing facilities and represents a key node in the company’s growing global manufacturing network. The post Fujifilm Selected with Six Others in FDA PreCheck Pilot Manufacturing Program appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Fujifilm Selected with Six Others in FDA PreCheck Pilot Manufacturing Program. Fujifilm’s Holly Springs facility is one of North America's largest end-to-end cell culture biopharmaceutical manufacturing facilities and represents a key node in the company’s growing global manufacturing network.
TL;DR: The post Fujifilm Selected with Six Others in FDA PreCheck Pilot Manufacturing Program appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Prime Medicine wins spat with Beam Therapeutics over AATD candidate

Prime Medicine is headed for the clinic after winning a dispute with Beam Therapeutics, another gene editing biotech with roots in the same lab. Arbitrators determined that a 2019 contract between the companies doesn't preclude ...

More: Prime Medicine wins spat with Beam Therapeutics over AATD candidate. Prime Medicine is headed for the clinic after winning a dispute with Beam Therapeutics, another gene editing biotech with roots in the same lab. Arbitrators determined that a 2019 contract between the companies doesn't preclude ...
TL;DR: Prime Medicine is headed for the clinic after winning a dispute with Beam Therapeutics, another gene editing biotech with roots in the same lab.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

FDA halts release of new drug rejection letters while working to formalize policy

The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an unnamed pharma company in April.

TL;DR: The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has learned, following a citizen’s petition from an unnamed pharma company in April.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

HHS lays groundwork for new FDA rule on releasing the CRLs

The Trump administration is pushing the FDA to cement the details behind its proactive public release of rejection letters sent to pharma companies. The rulemaking would clarify a policy that initially

More: HHS lays groundwork for new FDA rule on releasing the CRLs. The Trump administration is pushing the FDA to cement the details behind its proactive public release of rejection letters sent to pharma companies. The rulemaking would clarify a policy that initially
TL;DR: The Trump administration is pushing the FDA to cement the details behind its proactive public release of rejection letters sent to pharma companies.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Interface Mismatches Remain Key Barrier to Continuous Bioprocessing

Fully-continuous, automated bioprocessing is achievable only when processes are tightly integrated and engineered to eliminate volume mismatches between steps and digitally managed to ensure system-wide visibility and interventions. The post Interface Mismatches Remain Key Barrier to Continuous Bioprocessing appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Interface Mismatches Remain Key Barrier to Continuous Bioprocessing. Fully-continuous, automated bioprocessing is achievable only when processes are tightly integrated and engineered to eliminate volume mismatches between steps and digitally managed to ensure system-wide visibility and interventions.
TL;DR: The post Interface Mismatches Remain Key Barrier to Continuous Bioprocessing appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Local PBMC Isolation Enables Four-Hour Processing in San Diego

OrganaBio’s new San Diego cell processing site expands access to fast PBMC isolation and cryopreservation, thus improving quality, consistency, and supply chain surety for these vital CGT starting materials. The post Local PBMC Isolation Enables Four-Hour Processing in San Diego appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Local PBMC Isolation Enables Four-Hour Processing in San Diego. OrganaBio’s new San Diego cell processing site expands access to fast PBMC isolation and cryopreservation, thus improving quality, consistency, and supply chain surety for these vital CGT starting materials.
TL;DR: The post Local PBMC Isolation Enables Four-Hour Processing in San Diego appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Plant Expression Platforms May Be Better Option for Biopharma in the Global South

Mammalian cell-based biopharmaceutical manufacturing systems are complex, expensive, and, say the authors of a new study, not suited to producing medicines in resource-constrained environments. Plant-based protein expression platforms are a promising low-cost, more sustainable alternative. The post Plant Expression Platforms May Be Better Option for Biopharma in the Global South appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Mammalian cell-based biopharmaceutical manufacturing systems are complex, expensive, and, say the authors of a new study, not suited to producing medicines in resource-constrained environments. Plant-based protein expression platforms are a promising low-cost, more sustainable alternative.
TL;DR: The post Plant Expression Platforms May Be Better Option for Biopharma in the Global South appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Perfusion Technologies Gain Momentum in Biomanufacturing

As biologics developers face mounting pressure to increase output while controlling costs, perfusion-based manufacturing attracts renewed attention. Advances in media, automation, and AI-driven process control are helping overcome barriers to adoption and accelerating commercial deployment. The post Perfusion Technologies Gain Momentum in Biomanufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .

More: As biologics developers face mounting pressure to increase output while controlling costs, perfusion-based manufacturing attracts renewed attention. Advances in media, automation, and AI-driven process control are helping overcome barriers to adoption and accelerating commercial deployment.
TL;DR: The post Perfusion Technologies Gain Momentum in Biomanufacturing appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Oligonucleotide Therapeutic Industry Readies Itself to Move to the Next Phase

Synthetic oligonucleotide therapeutics are now validated for treating a wider range of diseases and, as companies move to larger-scale development, they should become familiar with the Chemistry, Man…

More: Oligonucleotide Therapeutic Industry Readies Itself to Move to the Next Phase. “But to achieve their potential, you need the right development strategy at the right time—you don’t want to apply late commercial staging to early development.” According to Cai, synthetic oligonucleotide therapeutics have seen significant development over the last decade.
TL;DR: Synthetic oligonucleotide therapeutics are now validated for treating a wider range of diseases and, as companies move to larger-scale development, they should become familiar with the Chemistry, Manufacturing, and Control (CMC) aspects of their workflow.
Read original at Genengnews
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Prime wins patent fight with Beam to continue work on AATD gene editing therapy

Prime Medicine has come out ahead in its patent dispute with fellow gene editing biotech Beam Therapeutics, after a panel of adjudicators ruled the company did not violate its agreement with Beam and can continue developing its lead asset for alpha-1 antitrypsin deficiency.

TL;DR: Prime Medicine has come out ahead in its patent dispute with fellow gene editing biotech Beam Therapeutics, after a panel of adjudicators ruled the company did not violate its agreement with Beam and can continue developing its lead asset for alpha-1 antitrypsin deficiency.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Novartis cuts New Jersey jobs; OTR, LG Chem explore China cancer drugs

Plus news about Seres, Biocytogen, Whitehawk, Boehringer Ingelheim, Prime Vector and MindRank. ⚠️ Novartis reduces New Jersey headcount: A WARN notice for the state notes that 322 employees in East Hanover ...

More: Novartis cuts New Jersey jobs; OTR, LG Chem explore China cancer drugs. Plus news about Seres, Biocytogen, Whitehawk, Boehringer Ingelheim, Prime Vector and MindRank. ⚠️ Novartis reduces New Jersey headcount: A WARN notice for the state notes that 322 employees in East Hanover ...
TL;DR: Plus news about Seres, Biocytogen, Whitehawk, Boehringer Ingelheim, Prime Vector and MindRank.
Read original at Endpoints
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Biohaven looks to take on Lilly in the muscle-sparing obesity space

They say that the way to make money in a gold rush is to open a shop selling picks and shovels. By the same token, perhaps companies can profit from the GLP-1 boom by developing ...

More: Biohaven looks to take on Lilly in the muscle-sparing obesity space. They say that the way to make money in a gold rush is to open a shop selling picks and shovels. By the same token, perhaps companies can profit from the GLP-1 boom by developing ...
TL;DR: They say that the way to make money in a gold rush is to open a shop selling picks and shovels.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Astrocytes Preserve Memory Persistence Through Ankyrin-2 Protein in Mice

How certain memories persist over time for learning and cognitive function remains unclear. A new study suggests that astrocytes play a critical role in long-term memory through the regulatory protein ankyrin-2 (Ank2).  The post Astrocytes Preserve Memory Persistence Through Ankyrin-2 Protein in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .

More:   Removing Ank2 function led to significantly impaired memory in mice after after two weeks.   Astrocytes lacking Ank2 formed significantly less physical contacts with nearby engram neurons, the specialized neurons for memory storage.
TL;DR: How certain memories persist over time for learning and cognitive function remains unclear. A new study suggests that astrocytes play a critical role in long-term memory through the regulatory protein ankyrin-2 (Ank2).  The post Astrocytes Preserve Memory Persistence Through Ankyrin-2 Protein in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Satellos’ ‘intriguing’ Duchenne data raise hopes ahead of key readout

Satellos Bioscience has shared evidence that its Duchenne muscular dystrophy drug candidate is active in adults, leading analysts to predict the molecule “could re-imagine the ... therapeutic landscape” if the biotech replicates the data in children.

More: Satellos’ ‘intriguing’ Duchenne data raise hopes ahead of key readout. Satellos Bioscience has shared evidence that its Duchenne muscular dystrophy drug candidate is active in adults, leading analysts to predict the molecule “could re-imagine the ... therapeutic landscape” if the biotech replicates the data in children.
TL;DR: Satellos Bioscience has shared evidence that its Duchenne muscular dystrophy drug candidate is active in adults, leading analysts to predict the molecule “could re-imagine the ...
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Scipher picks up Chemomab’s rheumatoid arthritis drug, Nasdaq listing in all-stock merger

Precision immunology company Scipher Medicine will absorb Chemomab Therapeutics after having identified the Israeli biotech’s rheumatoid arthritis drug as the ideal fit for its own expertise.

TL;DR: Precision immunology company Scipher Medicine will absorb Chemomab Therapeutics after having identified the Israeli biotech’s rheumatoid arthritis drug as the ideal fit for its own expertise.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Leo Cancer Care secures $65M series D to advance upright radiotherapy system

Medical technology company Leo Cancer Care closed a $65 million series D financing round to scale its radiotherapy solution that uses groundbreaking upright treatment technology.

TL;DR: Medical technology company Leo Cancer Care closed a $65 million series D financing round to scale its radiotherapy solution that uses groundbreaking upright treatment technology.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships

Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday. One will see the Hong Kong biotech license an investigational PDE3/4 inhibitor to AstraZeneca for $200 ...

More: Sino Biopharm hooks AstraZeneca, GSK for separate respiratory partnerships. Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday. One will see the Hong Kong biotech license an investigational PDE3/4 inhibitor to AstraZeneca for $200 ...
TL;DR: Sino Biopharmaceutical announced drug development and sales pacts with two UK pharma companies on Wednesday.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Satellos gives early look at Duchenne pill in adults ahead of key data in children

Satellos Bioscience is building its case for a Duchenne muscular dystrophy pill with data in adult patients ahead of a potentially pivotal readout in children later this year. The Canadian biotech’s Phase 2 study in ...

More: Satellos gives early look at Duchenne pill in adults ahead of key data in children. Satellos Bioscience is building its case for a Duchenne muscular dystrophy pill with data in adult patients ahead of a potentially pivotal readout in children later this year. The Canadian biotech’s Phase 2 study in ...
TL;DR: The Canadian biotech’s Phase 2 study in ...
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Opinion: The AI licensure debate is missing the point of licensure

“AI will reshape medicine. The physicians who answer for the outcome must lead the way it enters patient care," write Afnan R. Tariq and Ami Bhatt.

More: Opinion: The AI licensure debate is missing the point of licensure. The physicians who answer for the outcome must lead the way it enters patient care," write Afnan R. Tariq and Ami Bhatt.
TL;DR: “AI will reshape medicine.
Read original at Statnews
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Opinion: STAT+: What’s the right role for AI in dementia care?

Karlawish is a professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania’s Perelman School of Medicine, co-director of the Penn Memory Center, and executiv…

More: Karlawish is a professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania’s Perelman School of Medicine, co-director of the Penn Memory Center, and executive producer of the “Age of Aging“ podcast. After Doug met Jane, he felt good.
TL;DR: Three tricky questions about using AI in dementia care.
Read original at Statnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

AstraZeneca pens $2.1B Sino deal for challenger to Merck’s COPD drug Ohtuvayre

AstraZeneca is paying Sino Biopharmaceutical $200 million upfront for ex-China rights to a late-phase challenger to Merck & Co.’s chronic obstructive pulmonary disease drug Ohtuvayre.

TL;DR: AstraZeneca is paying Sino Biopharmaceutical $200 million upfront for ex-China rights to a late-phase challenger to Merck & Co.’s chronic obstructive pulmonary disease drug Ohtuvayre.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Novartis to Acquire Myricx Bio for Up to $1.5B, Adding Cancer-Fighting ADC Payload Platform

Myricx Bio specializes in developing ADCs that use N-myristoyltransferase inhibitor (NMTi) payloads, an approach designed to deliver a differentiated cancer-killing payload directly to tumor cells. Myricx says its ADC approach holds the potential to address limitations of TOPO-1 inhibitors, tubulin inhibitors, and other commonly used ADC payload classes—ranging from toxicity to healthy cells, to tumor resistance, to dose-limiting adverse events. The post Novartis to Acquire Myricx Bio for Up to $1.5B, Adding Cancer-Fighting ADC Payload Platform appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Myricx Bio specializes in developing ADCs that use N-myristoyltransferase inhibitor (NMTi) payloads, an approach designed to deliver a differentiated cancer-killing payload directly to tumor cells.
TL;DR: The post Novartis to Acquire Myricx Bio for Up to $1.5B, Adding Cancer-Fighting ADC Payload Platform appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Germline‑Targeting HIV Vaccine Generates Broadly Neutralizing Antibodies in Primates

Rhesus macaques received a priming immunogen designed to activate naive B cells, followed by a sequence of booster shots that guided those cells through the necessary maturation steps. The post Germline‑Targeting HIV Vaccine Generates Broadly Neutralizing Antibodies in Primates appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Germline‑Targeting HIV Vaccine Generates Broadly Neutralizing Antibodies in Primates. Rhesus macaques received a priming immunogen designed to activate naive B cells, followed by a sequence of booster shots that guided those cells through the necessary maturation steps.
TL;DR: The post Germline‑Targeting HIV Vaccine Generates Broadly Neutralizing Antibodies in Primates appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Vertex Eyes Expansion Beyond Cystic Fibrosis with Planned $10B Crinetics Buyout

Based in San Diego, Crinetics focuses on discovering, developing, and commercializing therapeutics for endocrine diseases. The company’s first marketed drug Palsonify ® (paltusotine), an oral SST2 agonist, was approved by the FDA in September as the first and to date only once-daily oral therapy for adults with acromegaly. The post Vertex Eyes Expansion Beyond Cystic Fibrosis with Planned $10B Crinetics Buyout appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Based in San Diego, Crinetics focuses on discovering, developing, and commercializing therapeutics for endocrine diseases. The company’s first marketed drug Palsonify ® (paltusotine), an oral SST2 agonist, was approved by the FDA in September as the first and to date only once-daily oral therapy for adults with acromegaly.
TL;DR: The post Vertex Eyes Expansion Beyond Cystic Fibrosis with Planned $10B Crinetics Buyout appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

AI Reveals Hidden Brain Lesions in Multiple Sclerosis MRI

Researchers combined AI with multiple image processing methods to reliably measure on existing multiple sclerosis MRI scans cortical lesions strongly implicated in disability and cognitive, which would previously have remained undetected. The post AI Reveals Hidden Brain Lesions in Multiple Sclerosis MRI appeared first on GEN - Genetic Engineering and Biotechnology News .

More: AI Reveals Hidden Brain Lesions in Multiple Sclerosis MRI. Researchers combined AI with multiple image processing methods to reliably measure on existing multiple sclerosis MRI scans cortical lesions strongly implicated in disability and cognitive, which would previously have remained undetected.
TL;DR: The post AI Reveals Hidden Brain Lesions in Multiple Sclerosis MRI appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Vertex's Crinetics deal points to big ambitions for cystic fibrosis leader

Vertex Pharmaceuticals' $10 billion acquisition of an endocrinology startup represents the company’s clearest and boldest step toward the upper echelon of the biopharma industry. Long a biotech success in cystic fibrosis, Vertex has been angling ...

More: Vertex's Crinetics deal points to big ambitions for cystic fibrosis leader. Vertex Pharmaceuticals' $10 billion acquisition of an endocrinology startup represents the company’s clearest and boldest step toward the upper echelon of the biopharma industry. Long a biotech success in cystic fibrosis, Vertex has been angling ...
TL;DR: Vertex Pharmaceuticals' $10 billion acquisition of an endocrinology startup represents the company’s clearest and boldest step toward the upper echelon of the biopharma industry.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Tampa General kicks off legal fight over Lilly's 340B restrictions

Tampa General Hospital sued Eli Lilly for halting its 340B discounts, kicking off a broader fight over whether pharmaceutical companies can condition drug discounts on new claims data requirements. In a lawsuit filed Thursday, Tampa ...

More: Tam&shy;pa Gen&shy;er&shy;al Hos&shy;pi&shy;tal sued Eli Lil&shy;ly for halt&shy;ing its 340B dis&shy;counts, kick&shy;ing off a broad&shy;er fight over whether phar&shy;ma&shy;ceu&shy;ti&shy;cal com&shy;pa&shy;nies can con&shy;di&shy;tion drug dis&shy;counts on … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Tampa General Hospital sued Eli Lilly for halting its 340B discounts, kicking off a broader fight over whether pharmaceutical companies can condition drug discounts on new claims data requirements.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

The Quest for Large-Scale DNA

As genome editing therapies move through clinical trials to regulatory approval, scientists continue the quest for the holy grail of large-scale DNA editing.. The post The Quest for Large-Scale DNA appeared first on GEN - Genetic Engineering and Biotechnology News .

More: The Quest for Large-Scale DNA. As genome editing therapies move through clinical trials to regulatory approval, scientists continue the quest for the holy grail of large-scale DNA editing.. The post The Quest for Large-Scale DNA appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post The Quest for Large-Scale DNA appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Vera's IgAN approval kicks off competition with Otsuka

Vera Therapeutics’ fusion protein atacicept got an accelerated approval on Tuesday for a chronic autoimmune disease that damages the kidneys. The drug will be marketed as Trutakna for immunoglobulin A nephropathy ...

More: Vera's IgAN approval kicks off competition with Otsuka. Vera Therapeutics’ fusion protein atacicept got an accelerated approval on Tuesday for a chronic autoimmune disease that damages the kidneys. The drug will be marketed as Trutakna for immunoglobulin A nephropathy ...
TL;DR: Vera Therapeutics’ fusion protein atacicept got an accelerated approval on Tuesday for a chronic autoimmune disease that damages the kidneys.
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Biotech and Biomed Engineering Grad and Certificate Programs to Debut at Auburn

Biomedical engineering focuses on developing technologies and systems that improve how diseases and injuries are understood, diagnosed, monitored, and treated. The post Biotech and Biomed Engineering Grad and Certificate Programs to Debut at Auburn appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Biotech and Biomed Engineering Grad and Certificate Programs to Debut at Auburn. Biomedical engineering focuses on developing technologies and systems that improve how diseases and injuries are understood, diagnosed, monitored, and treated.
TL;DR: The post Biotech and Biomed Engineering Grad and Certificate Programs to Debut at Auburn appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

MeiraGTx scores $400M from Oberland Capital to help get 2 gene therapies to commercialization

As MeiraGTx lines up the pieces for a commercial push, the company has new funding to work with.

More: MeiraGTx scores $400M from Oberland Capital to help get 2 gene therapies to commercialization. As MeiraGTx lines up the pieces for a commercial push, the company has new funding to work with.
TL;DR: As MeiraGTx lines up the pieces for a commercial push, the company has new funding to work with.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Beckman Coulter grows Alzheimer’s dx portfolio with CE mark for new assay

Diagnostics specialist Beckman Coulter expanded its portfolio of Alzheimer’s disease diagnostics by earning a CE mark in Europe for its Access p-Tau217 assay.

TL;DR: Diagnostics specialist Beckman Coulter expanded its portfolio of Alzheimer’s disease diagnostics by earning a CE mark in Europe for its Access p-Tau217 assay.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Bioprocessing at Full Throttle

Intensified strategies are reshaping biologics manufacturing by boosting speed, flexibility, and productivity without expanding facilities or footprints. The post Bioprocessing at Full Throttle appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Bioprocessing at Full Throttle. Intensified strategies are reshaping biologics manufacturing by boosting speed, flexibility, and productivity without expanding facilities or footprints. The post Bioprocessing at Full Throttle appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Bioprocessing at Full Throttle appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Compass Pathways touts durability data for psilocybin drug in depression ahead of year-end filing

Compass Pathways said Tuesday that patients in the second of its two pivotal psilocybin trials maintained their response to treatment for at least six months, keeping the company on track to complete its NDA filing ...

More: Com&shy;pass Path&shy;ways said Tues&shy;day that pa&shy;tients in the sec&shy;ond of its two piv&shy;otal psilo&shy;cy&shy;bin tri&shy;als main&shy;tained their re&shy;sponse to treat&shy;ment for at least six months … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Compass Pathways said Tuesday that patients in the second of its two pivotal psilocybin trials maintained their response to treatment for at least six months, keeping the company on track to complete its NDA filing ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Hengrui, Kailera's GLP-1 pill posts encouraging efficacy but high side effect rates in late-stage China trials

The GLP-1 pill being developed by Hengrui Pharma and Kailera Therapeutics posted decent results in two late-stage China-based trials — one in obesity and the other in diabetes. But the safety profile of the daily pill ...

More: The GLP-1 pill being developed by Hengrui Pharma and Kailera Therapeutics posted decent results in two late-stage China-based trials — one in obesity and the other in diabetes. But the safety profile of the daily pill ...
TL;DR: The GLP-1 pill being developed by Hengrui Pharma and Kailera Therapeutics posted decent results in two late-stage China-based trials — one in obesity and the other in diabetes.
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Novartis, Vertex and Ipsen extend pharma M&A spree from 2026's first half

Biopharma's M&A engine is revved up and shows no signs of cooling off. Four companies have announced acquisitions in the first six days of July, forging deals that could pay out as much as $12.6 ...

More: Novartis, Vertex and Ipsen extend pharma M&A spree from 2026's first half. Biopharma's M&A engine is revved up and shows no signs of cooling off. Four companies have announced acquisitions in the first six days of July, forging deals that could pay out as much as $12.6 ...
TL;DR: Four companies have announced acquisitions in the first six days of July, forging deals that could pay out as much as $12.6 ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

AI Tackles Tuberculosis, Identifies Drugs that Penetrate Bacteria Membrane

Researchers have developed a new AI approach to select chemical compounds that can penetrate the bacterial membrane to treat tuberculosis, one of the world’s deadliest single-agent caused infections. The post AI Tackles Tuberculosis, Identifies Drugs that Penetrate Bacteria Membrane appeared first on GEN - Genetic Engineering and Biotechnology News .

More: AI Tackles Tuberculosis, Identifies Drugs that Penetrate Bacteria Membrane. Researchers have developed a new AI approach to select chemical compounds that can penetrate the bacterial membrane to treat tuberculosis, one of the world’s deadliest single-agent caused infections.
TL;DR: The post AI Tackles Tuberculosis, Identifies Drugs that Penetrate Bacteria Membrane appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

MeiraGTx strikes royalty deal; Fore's 2023 Series D continues

Plus, news about Kalohexis, Teva and Agios: 👑 MeiraGTx makes royalty deal with Oberland Capital: The gene therapy maker will get an initial $135 million via a $10 million equity investment ...

More: 👑 MeiraGTx makes roy&shy;al&shy;ty deal with Ober&shy;land Cap&shy;i&shy;tal: The gene ther&shy;a&shy;py mak&shy;er will get … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Plus, news about Kalohexis, Teva and Agios: 👑 MeiraGTx makes royalty deal with Oberland Capital: The gene therapy maker will get an initial $135 million via a $10 million equity investment ...
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Whitehawk swoops in for five ADCs via development deal with China's Biocytogen

Biocytogen and Whitehawk Therapeutics are joining forces to develop bispecific antibody-drug conjugates using Biocytogen's discovery platform.

More: Whitehawk swoops in for five ADCs via development deal with China's Biocytogen. Biocytogen and Whitehawk Therapeutics are joining forces to develop bispecific antibody-drug conjugates using Biocytogen's discovery platform.
TL;DR: Biocytogen and Whitehawk Therapeutics are joining forces to develop bispecific antibody-drug conjugates using Biocytogen's discovery platform.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

KLK1 Expands Possibilities to Restore Vascular Health

By restoring the body’s ability to produce KLK1, therapies are emerging for preeclampsia moms and for acute ischemic stroke who missed the tPA window. The post KLK1 Expands Possibilities to Restore Vascular Health appeared first on GEN - Genetic Engineering and Biotechnology News .

More: KLK1 Expands Possibilities to Restore Vascular Health. By restoring the body’s ability to produce KLK1, therapies are emerging for preeclampsia moms and for acute ischemic stroke who missed the tPA window. The post KLK1 Expands Possibilities to Restore Vascular Health appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post KLK1 Expands Possibilities to Restore Vascular Health appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

A New Approach to Supporting Quality of Biologics

The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experience in setting public standards […] The post A New Approach to Supporting Quality of Biologics appeared first on GEN - Genetic Engineering and Biotechnology News .

More: A New Approach to Supporting Quality of Biologics. The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines.
TL;DR: Building on decades of experience in setting public standards […] The post A New Approach to Supporting Quality of Biologics appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

A New Development Playbook for PROTACs

In this Thought Leader article from our July issue, Shanghao Li, PhD, explores why translation will define the next wave of success. The post A New Development Playbook for PROTACs appeared first on GEN - Genetic Engineering and Biotechnology News .

More: A New Development Playbook for PROTACs. In this Thought Leader article from our July issue, Shanghao Li, PhD, explores why translation will define the next wave of success. The post A New Development Playbook for PROTACs appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post A New Development Playbook for PROTACs appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Endevica spinout Kalohexis submits confidential IPO filing to develop obesity challenger to GLP-1s

Clinical-stage Kalohexis is readying a public listing to support its obesity and cancer cachexia treatments.

More: Endevica spinout Kalohexis submits confidential IPO filing to develop obesity challenger to GLP-1s. Clinical-stage Kalohexis is readying a public listing to support its obesity and cancer cachexia treatments.
TL;DR: Clinical-stage Kalohexis is readying a public listing to support its obesity and cancer cachexia treatments.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Conquering Medicare's ACCESS program

There was so much excitement when CMS announced the ACCESS program. Finally, a way for digital health companies to make their mark on Medicare! A program that pays only if patients get better! But that ...

More: Conquering Medicare's ACCESS program. Finally, a way for digital health companies to make their mark on Medicare! A program that pays only if patients get better!
TL;DR: There was so much excitement when CMS announced the ACCESS program.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Boehringer bags PVT’s viral vector platform for cancer vaccine R&D

Boehringer Ingelheim has landed an exclusive license to Prime Vector Technologies’ viral vector platform for developing next-generation cancer vaccines.

TL;DR: Boehringer Ingelheim has landed an exclusive license to Prime Vector Technologies’ viral vector platform for developing next-generation cancer vaccines.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

How digital health companies are planning to conquer CMS ACCESS

A new Medicare experiment to manage seniors’ chronic diseases will pay some digital health companies only about as much in a year as they might earn for a couple of patient visits from commercial insurers. ...

More: A new Medicare ex&shy;per&shy;i&shy;ment to man&shy;age se&shy;niors’ chron&shy;ic dis&shy;eases will pay some dig&shy;i&shy;tal health com&shy;pa&shy;nies on&shy;ly about as much in a year as they might … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: A new Medicare experiment to manage seniors’ chronic diseases will pay some digital health companies only about as much in a year as they might earn for a couple of patient visits from commercial insurers.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Kailera’s oral GLP-1 asset sees 11% weight loss, hits goals in Chinese phase 3 obesity and diabetes trials

Phase 3 trials of Kailera Therapeutics’ oral GLP-1 prospect have hit their primary endpoints, positioning the biotech’s partner Hengrui Pharma to seek approval in obesity and diabetes in China.

TL;DR: Phase 3 trials of Kailera Therapeutics’ oral GLP-1 prospect have hit their primary endpoints, positioning the biotech’s partner Hengrui Pharma to seek approval in obesity and diabetes in China.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Biomanufacturing in Space to Be Key Topic at ISSCR 2026

Scientists from the Cedars-Sinai Board of Governors Regenerative Medicine Institute, including investigators from the Cedars-Sinai Biomanufacturing Center, say they will share groundbreaking discoveries and discuss new frontiers in research at ISSCR 2026. The post Biomanufacturing in Space to Be Key Topic at ISSCR 2026 appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Biomanufacturing in Space to Be Key Topic at ISSCR 2026. Scientists from the Cedars-Sinai Board of Governors Regenerative Medicine Institute, including investigators from the Cedars-Sinai Biomanufacturing Center, say they will share groundbreaking discoveries and discuss new frontiers in research at ISSCR 2026.
TL;DR: The post Biomanufacturing in Space to Be Key Topic at ISSCR 2026 appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B

Vertex Pharmaceuticals has struck a $10 billion deal—its largest ever—to acquire endocrine disease specialist Crinetics Pharmaceuticals. The transaction's two focuses, Palsonify and atumelnant, have combined peak sales potential of more than $5 billion, Vertex said.

More: Vertex, in its largest-ever deal, acquires endocrine disease specialist Crinetics for $10B. Vertex Pharmaceuticals has struck a $10 billion deal—its largest ever—to acquire endocrine disease specialist Crinetics Pharmaceuticals. The transaction's two focuses, Palsonify and atumelnant, have combined peak sales potential of more than $5 billion, Vertex said.
TL;DR: Vertex Pharmaceuticals has struck a $10 billion deal—its largest ever—to acquire endocrine disease specialist Crinetics Pharmaceuticals.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

French gene therapy biotech gets €33M to follow Krystal's blueprint

A small French-US biotech has gathered more funds to see if it can follow in the footsteps of Krystal Biotech in the HSV-based gene therapy field, but in a different therapeutic area. Cyllene Therapeutics raised ...

More: A small French-US biotech has gath&shy;ered more funds to see if it can fol&shy;low in the foot&shy;steps of Krys&shy;tal Biotech in the HSV-based gene ther&shy;a&shy;py … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: A small French-US biotech has gathered more funds to see if it can follow in the footsteps of Krystal Biotech in the HSV-based gene therapy field, but in a different therapeutic area.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

New sa‑mRNA and LNP Platform to Support Korea’s Hantavirus Vaccine Initiative

Building on promising preclinical findings, researchers in South Korea are developing a hantavirus vaccine using self-amplifying mRNA technology, aiming to establish a domestically developed platform for rapid responses to future infectious disease outbreaks. The post New sa‑mRNA and LNP Platform to Support Korea’s Hantavirus Vaccine Initiative appeared first on GEN - Genetic Engineering and Biotechnology News .

More: New sa‑mRNA and LNP Platform to Support Korea’s Hantavirus Vaccine Initiative. Building on promising preclinical findings, researchers in South Korea are developing a hantavirus vaccine using self-amplifying mRNA technology, aiming to establish a domestically developed platform for rapid responses to future infectious disease outbreaks.
TL;DR: The post New sa‑mRNA and LNP Platform to Support Korea’s Hantavirus Vaccine Initiative appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Vertex makes $10B deal for commercial endocrinology biotech Crinetics

Vertex Pharmaceuticals is making the largest acquisition in its history, beefing up its commercial portfolio with a $10 billion takeover of Crinetics Pharmaceuticals. The Boston drugmaker said Monday afternoon it will ...

More: Vertex makes $10B deal for commercial endocrinology biotech Crinetics. Vertex Pharmaceuticals is making the largest acquisition in its history, beefing up its commercial portfolio with a $10 billion takeover of Crinetics Pharmaceuticals. The Boston drugmaker said Monday afternoon it will ...
TL;DR: Vertex Pharmaceuticals is making the largest acquisition in its history, beefing up its commercial portfolio with a $10 billion takeover of Crinetics Pharmaceuticals.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Unlocking Microbiome Function with Anaerobic Workflows and Metabolic Phenotyping

This eBook explores how researchers can move beyond correlation and towards mechanism in microbiome research—from preserving physiologically relevant microbial communities to directly measuring microbial function through phenotyping. The post Unlocking Microbiome Function with Anaerobic Workflows and Metabolic Phenotyping appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Unlocking Microbiome Function with Anaerobic Workflows and Metabolic Phenotyping. This eBook explores how researchers can move beyond correlation and towards mechanism in microbiome research—from preserving physiologically relevant microbial communities to directly measuring microbial function through phenotyping.
TL;DR: The post Unlocking Microbiome Function with Anaerobic Workflows and Metabolic Phenotyping appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

FDA approves 23 new drugs in first half, overcoming staff-cut concerns

There's an answer emerging on the multibillion-dollar question of whether the Trump administration's gutting of FDA staff in April 2025 would slow down drug approvals: So far, so good. In the

More: There’s an an&shy;swer emerg&shy;ing on the multi&shy;bil&shy;lion-dol&shy;lar ques&shy;tion of whether the Trump ad&shy;min&shy;is&shy;tra&shy;tion’s gut&shy;ting of FDA staff in April 2025 would slow down drug ap&shy;provals: … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: There's an answer emerging on the multibillion-dollar question of whether the Trump administration's gutting of FDA staff in April 2025 would slow down drug approvals: So far, so good.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

New CDER appointment elevates longtime GLP-1 reviewer

Acting FDA CDER director Michael Davis has promoted a longtime FDA staffer as an acting deputy director at the drug center. Lisa Yanoff, an agency veteran with expertise in metabolic drug reviews, is taking over ...

More: New CDER appointment elevates longtime GLP-1 reviewer. Acting FDA CDER director Michael Davis has promoted a longtime FDA staffer as an acting deputy director at the drug center. Lisa Yanoff, an agency veteran with expertise in metabolic drug reviews, is taking over ...
TL;DR: Acting FDA CDER director Michael Davis has promoted a longtime FDA staffer as an acting deputy director at the drug center.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Chimeric Allergen Receptor Treg Cells Suppress Allergic Asthma in Mice

Researchers developed regulatory T cells armed with chimeric allergen receptors—CAlleR Tregs—which in tests reduced or preventing asthma symptoms in mice sensitized to a birch tree pollen allergen, and suggest that their approach could eventually be used to treat a wide variety of allergies in humans. The post Chimeric Allergen Receptor Treg Cells Suppress Allergic Asthma in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Chimeric Allergen Receptor Treg Cells Suppress Allergic Asthma in Mice. Researchers developed regulatory T cells armed with chimeric allergen receptors—CAlleR Tregs—which in tests reduced or preventing asthma symptoms in mice sensitized to a birch tree pollen allergen, and suggest that their approach could eventually be used to treat a wide variety of allergies in humans.
TL;DR: The post Chimeric Allergen Receptor Treg Cells Suppress Allergic Asthma in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Pharma Races to Scale AI as Billions Flow into Drug Discovery

Investors unpack what it takes to succeed in an increasingly crowded AI biology ecosystem. The post Pharma Races to Scale AI as Billions Flow into Drug Discovery appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Pharma Races to Scale AI as Billions Flow into Drug Discovery. Investors unpack what it takes to succeed in an increasingly crowded AI biology ecosystem. The post Pharma Races to Scale AI as Billions Flow into Drug Discovery appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Pharma Races to Scale AI as Billions Flow into Drug Discovery appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Bristol Myers details Krazati confirmatory study failure in colorectal cancer

While Americans geared up for the July 4 holiday, Bristol Myers Squibb laid out how a confirmatory trial for its drug Krazati failed in colorectal cancer. Patients taking Krazati plus another drug, the EGFR inhibitor ...

More: While Americans geared up for the July 4 holiday, Bristol Myers Squibb laid out how a confirmatory trial for its drug Krazati failed in colorectal cancer. Patients taking Krazati plus another drug, the EGFR inhibitor ...
TL;DR: While Americans geared up for the July 4 holiday, Bristol Myers Squibb laid out how a confirmatory trial for its drug Krazati failed in colorectal cancer.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Roche aims to bolster breast cancer pipeline with early-stage Astex deal

Monday’s deal between Otsuka’s subsidiary Astex and Roche’s subsidiary Genentech is of interest not because it is big money — the upfront fee is just $25 million — but because of what it says about Roche’s cancer ...

More: Mon&shy;day’s deal be&shy;tween Ot&shy;su&shy;ka’s sub&shy;sidiary As&shy;tex and Roche’s sub&shy;sidiary Genen&shy;tech is of in&shy;ter&shy;est not be&shy;cause it is big mon&shy;ey — the up&shy;front fee is just $25 … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Monday’s deal between Otsuka’s subsidiary Astex and Roche’s subsidiary Genentech is of interest not because it is big money — the upfront fee is just $25 million — but because of what it says about Roche’s cancer ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Apogee details path to $10.9B AbbVie deal; UK starts drug pricing pilot

Plus news about Brii Biosciences. 💰 How AbbVie got Apogee: The Chicago-area drug giant snagged Apogee Therapeutics for $10.9 billion last month after years of talking with the biotech. AbbVie held discussions ...

More: Apogee details path to $10.9B AbbVie deal; UK starts drug pricing pilot. 💰 How AbbVie got Apogee: The Chicago-area drug giant snagged Apogee Therapeutics for $10.9 billion last month after years of talking with the biotech. AbbVie held discussions ...
TL;DR: Plus news about Brii Biosciences.
Read original at Endpoints
Further reading: PubMedGenome.govBioTech PrimerWikipedia

ALS Drug Extends Survival in Mice, Targets TDP-43 Low-Complexity Domain

A new therapeutic target shields nerve cells from the damage of ALS. A novel drug candidate extended median survival by approximately a week, protected nerve cells and reduced muscle weakness in mice. The post ALS Drug Extends Survival in Mice, Targets TDP-43 Low-Complexity Domain appeared first on GEN - Genetic Engineering and Biotechnology News .

More: A new therapeutic target shields nerve cells from the damage of ALS. A novel drug candidate extended median survival by approximately a week, protected nerve cells and reduced muscle weakness in mice. The post ALS Drug Extends Survival in Mice, Targets TDP-43 Low-Complexity Domain appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post ALS Drug Extends Survival in Mice, Targets TDP-43 Low-Complexity Domain appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Four major biotech updates to catch up on

Happy post-fourth. Hope you had a nice extended weekend, and hi from San Francisco!  Today, we’re reading about Medicare proposing staggering cuts to 340B payments, Republicans moving to preserve div…

More: Anthropic CEO Dario Amodei is tempering his own bold predictions about AI transforming biotechnology, STAT’s Matt Herper writes. While, sure, AI could eventually compress decades of scientific progress into years, biology’s inherent complexity and glacial timelines mean that future remains years away.
TL;DR: Anthropic CEO talks drug discovery, Medicare proposes steep 340B drug payment cuts, and more biotech news
Read original at Statnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Salk Institute’s president on NIH cuts, ‘all in’ on AI, and the Year of the Brain

SAN DIEGO — From the president’s office at the Salk Institute, Gerald Joyce has a quintessential California view of hang gliders soaring over the Pacific Ocean. It’s been a little more turbulent for US research centers ...

More: Salk Institute’s president on NIH cuts, ‘all in’ on AI, and the Year of the Brain. SAN DIEGO — From the president’s office at the Salk Institute, Gerald Joyce has a quintessential California view of hang gliders soaring over the Pacific Ocean. It’s been a little more turbulent for US research centers ...
TL;DR: SAN DIEGO — From the president’s office at the Salk Institute, Gerald Joyce has a quintessential California view of hang gliders soaring over the Pacific Ocean.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Scribe notes down IPO ambition to fund lipid-lowering genetic meds through clinical trials

Scribe Therapeutics is the latest biotech to prepare a public listing, as the company looks to propel its lipid-lowering medicines through clinical trials.

TL;DR: Scribe Therapeutics is the latest biotech to prepare a public listing, as the company looks to propel its lipid-lowering medicines through clinical trials.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Caris Life Sciences launches cancer blood test ‘Caris Detect’

Caris Life Sciences has launched a new oncology blood test designed alongside AI modelling to pick up cancer at earlier stages.

TL;DR: Caris Life Sciences has launched a new oncology blood test designed alongside AI modelling to pick up cancer at earlier stages.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

Exact Imaging boosts U.S. commercial team for next-gen prostate cancer testing tech

Exact Imaging is looking to broaden uptake of its high-resolution micro-ultrasound system for prostate cancer screening and is boosting its commercial team to help.

TL;DR: Exact Imaging is looking to broaden uptake of its high-resolution micro-ultrasound system for prostate cancer screening and is boosting its commercial team to help.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Novartis commits $1.1B upfront to take Myricx Bio and its next-gen ADC platform

Novartis said Monday it will be spending $1.1 billion upfront to buy Myricx Bio, which has an ADC payload platform that could offer an edge over current approaches. The Swiss drugmaker will get Myricx’s NMT ...

More: Novartis said Monday it will be spending $1.1 billion upfront to buy Myricx Bio, which has an ADC payload platform that could offer an edge over current approaches. The Swiss drugmaker will get Myricx’s NMT ...
TL;DR: Novartis said Monday it will be spending $1.1 billion upfront to buy Myricx Bio, which has an ADC payload platform that could offer an edge over current approaches.
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Genentech lays off 103 alongside gRED rethink, pens $490M breast cancer collab

A month after Genentech confirmed the restructuring of its early development group, the Roche subsidiary has now disclosed that this has formed part of a round of 103 layoffs.

TL;DR: A month after Genentech confirmed the restructuring of its early development group, the Roche subsidiary has now disclosed that this has formed part of a round of 103 layoffs.
Read original at Fiercebiotech
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Novartis to pay $1.1B upfront for UK biotech Myricx to expand the pharma's ADC pipeline

Novartis is pushing deeper into antibody-drug conjugate development, paying $1.1 billion upfront to buy Myricx Bio for a pipeline based on a novel payload.

TL;DR: Novartis is pushing deeper into antibody-drug conjugate development, paying $1.1 billion upfront to buy Myricx Bio for a pipeline based on a novel payload.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

StockWatch: New UC Data Sparks Smoother Sailing for Abivax

Less than a month after its stock roller-coastered on safety signals associated with its late-stage ulcerative colitis (UC) drug candidate obefazimod, shares of Abivax (Euronext Paris and Nasdaq: ABVX) enjoyed smoother sailing this past week—namely a 63% surge in Europe and a 50% leap in the United States over four trading days, following more positive data that appeared to reassure investors. The post StockWatch: New UC Data Sparks Smoother Sailing for Abivax appeared first on GEN - Genetic Engineering and Biotechnology News .

More: StockWatch: New UC Data Sparks Smoother Sailing for Abivax. Less than a month after its stock roller-coastered on safety signals associated with its late-stage ulcerative colitis (UC) drug candidate obefazimod, shares of Abivax (Euronext Paris and Nasdaq: ABVX) enjoyed smoother sailing this past week—namely a 63% surge in Europe and a 50% leap in the United States over four tr…
TL;DR: The post StockWatch: New UC Data Sparks Smoother Sailing for Abivax appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Anthropic launches Claude Science; House China panel probes trial sites; and more

Happy Fourth of July! We’ve got a handful of stories worth checking out before the backyard barbecue begins. But first: a reminder to submit your nominations for this year’s Women in Biopharma ...

More: Anthropic launches Claude Science; House China panel probes trial sites; and more. Happy Fourth of July! We’ve got a handful of stories worth checking out before the backyard barbecue begins.
TL;DR: But first: a reminder to submit your nominations for this year’s Women in Biopharma ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

United Therapeutics pays $140M for thymic cell therapy startup

United Therapeutics has paid $140 million to buy Thymmune Therapeutics for preclinical regenerative cell therapies focused on the thymus.

TL;DR: United Therapeutics has paid $140 million to buy Thymmune Therapeutics for preclinical regenerative cell therapies focused on the thymus.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

AstraZeneca pens $1.7B kidney drug discovery pact with go-to Chinese partner CSPC

AstraZeneca has added another piece to its sprawling interface with CSPC Pharmaceutical, paying the Chinese biotech $30 million upfront to jointly discover and develop two kidney disease drug candidates.

TL;DR: AstraZeneca has added another piece to its sprawling interface with CSPC Pharmaceutical, paying the Chinese biotech $30 million upfront to jointly discover and develop two kidney disease drug candidates.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

When clinical AI gets real

We’re heading toward a future in which certain parts of medical care are delivered without any humans involved. Cadence, which raised a $100 million Series C last week, is betting that it can make managing ...

More: When clinical AI gets real. We’re heading toward a future in which certain parts of medical care are delivered without any humans involved. Cadence, which raised a $100 million Series C last week, is betting that it can make managing ...
TL;DR: We’re heading toward a future in which certain parts of medical care are delivered without any humans involved.
Read original at Endpoints
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Scribe Therapeutics files for IPO in test of appetite for early-stage biotechs

Scribe Therapeutics filed for a Nasdaq IPO late Thursday. The move marks a pivotal moment for the biotech and the gene-editing field. The novel CRISPR enzyme developer was created nine years ...

More: Scribe Therapeutics files for IPO in test of appetite for early-stage biotechs. The move marks a pivotal moment for the biotech and the gene-editing field. The novel CRISPR enzyme developer was created nine years ...
TL;DR: Scribe Therapeutics filed for a Nasdaq IPO late Thursday.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Synthetic Organizers Aid Creation of Reproducible Kidney Organoids from Stem Cells

Using techniques including spatial transcriptomics, researchers identified a developmental axis that helps organize developing kidney nephrons, and engineered Wnt-secreting “synthetic organizer” cells to recreate aspects of this developmental environment in organoids created from stem cells. The post Synthetic Organizers Aid Creation of Reproducible Kidney Organoids from Stem Cells appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Synthetic Organizers Aid Creation of Reproducible Kidney Organoids from Stem Cells. Using techniques including spatial transcriptomics, researchers identified a developmental axis that helps organize developing kidney nephrons, and engineered Wnt-secreting “synthetic organizer” cells to recreate aspects of this developmental environment in organoids created from stem cells.
TL;DR: The post Synthetic Organizers Aid Creation of Reproducible Kidney Organoids from Stem Cells appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Elixirgen Builds Rare Disease Pipeline Around Telomere Biology Disorders and DMD

Elixirgen's lead program is an ex vivo autologous therapy based on proprietary tech that targets telomere biology disorders, rare genetic diseases characterized by short telomeres and telomerase mutations. The post Elixirgen Builds Rare Disease Pipeline Around Telomere Biology Disorders and DMD appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Elixirgen Builds Rare Disease Pipeline Around Telomere Biology Disorders and DMD. Elixirgen's lead program is an ex vivo autologous therapy based on proprietary tech that targets telomere biology disorders, rare genetic diseases characterized by short telomeres and telomerase mutations.
TL;DR: The post Elixirgen Builds Rare Disease Pipeline Around Telomere Biology Disorders and DMD appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Sandoz launches direct-to-consumer platform with growth disorder drug

Sandoz unveiled a direct-to-consumer platform, starting off with a single medication for now as the generic drugmaker adopts a system that several brand-name manufacturers are using to cut out-of-pocket costs for some patients. The Novartis ...

More: San&shy;doz un&shy;veiled a di&shy;rect-to-con&shy;sumer plat&shy;form, start&shy;ing off with a sin&shy;gle med&shy;ica&shy;tion for now as the gener&shy;ic drug&shy;mak&shy;er adopts a sys&shy;tem that sev&shy;er&shy;al brand-name man&shy;u&shy;fac&shy;tur&shy;ers are … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Sandoz unveiled a direct-to-consumer platform, starting off with a single medication for now as the generic drugmaker adopts a system that several brand-name manufacturers are using to cut out-of-pocket costs for some patients.
Read original at Endpoints
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Merck and Insilico Make Deals, Claude Science’s Debut, Vaccines for Neglected Diseases

In this episode of GEN 's Touching Base , editors talk about the multi-billion-dollar Merck KGaA Bio-Techne acquisition and Insilico–SK collaboration, AI antibiotic design with Claude Science, and progress in vaccines against schistosomiasis, Nipah, and Hendra viruses. The post Merck and Insilico Make Deals, Claude Science’s Debut, Vaccines for Neglected Diseases appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Merck and Insilico Make Deals, Claude Science’s Debut, Vaccines for Neglected Diseases. In this episode of GEN 's Touching Base , editors talk about the multi-billion-dollar Merck KGaA Bio-Techne acquisition and Insilico–SK collaboration, AI antibiotic design with Claude Science, and progress in vaccines against schistosomiasis, Nipah, and Hendra viruses.
TL;DR: The post Merck and Insilico Make Deals, Claude Science’s Debut, Vaccines for Neglected Diseases appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

ASMS 2026: Solving Proteomics’ Next Bottleneck

At the 74 th ASMS Conference, the obvious story was hardware. But after several days at the conference, it became clear that the field is beginning to look past the instrument toward the future of proteomics. The post ASMS 2026: Solving Proteomics’ Next Bottleneck appeared first on GEN - Genetic Engineering and Biotechnology News .

More: At the 74 th ASMS Conference, the obvious story was hardware. But after several days at the conference, it became clear that the field is beginning to look past the instrument toward the future of proteomics. The post ASMS 2026: Solving Proteomics’ Next Bottleneck appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post ASMS 2026: Solving Proteomics’ Next Bottleneck appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Revolution Medicines shares promising data around KRAS drug combination

Revolution Medicines on Thursday gave a first look at the early-stage data that led it to plan a Phase 3 trial combining two KRAS drugs in pancreatic cancer. One of the two drugs is a ...

More: Rev&shy;o&shy;lu&shy;tion Med&shy;i&shy;cines on Thurs&shy;day gave a first look at the ear&shy;ly-stage da&shy;ta that led it to plan a Phase 3 tri&shy;al com&shy;bin&shy;ing two KRAS drugs … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Revolution Medicines on Thursday gave a first look at the early-stage data that led it to plan a Phase 3 trial combining two KRAS drugs in pancreatic cancer.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Otsuka reports long-term kidney data key to Voyxact's bid for full approval

Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabilized kidney function ...

More: Otsuka reports long-term kidney data key to Voyxact's bid for full approval. Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabilized kidney function ...
TL;DR: Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

IPF biotech Celea gets $180M to follow paths of PureTech's Karuna, Seaport

With major backing from new investors, Celea Therapeutics hopes to follow in the footsteps of its siblings Seaport Therapeutics and Karuna Therapeutics. Celea has corralled $180 million to see if

More: IPF biotech Celea gets $180M to follow paths of PureTech's Karuna, Seaport. With major backing from new investors, Celea Therapeutics hopes to follow in the footsteps of its siblings Seaport Therapeutics and Karuna Therapeutics. Celea has corralled $180 million to see if
TL;DR: With major backing from new investors, Celea Therapeutics hopes to follow in the footsteps of its siblings Seaport Therapeutics and Karuna Therapeutics.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Vertex's sickle cell therapy approved for kids; United Therapeutics buys startup

🧬 Vertex’s sickle cell gene therapy approved for kids: Casgevy may now be used to treat either sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia patients as young as ...

More: 🧬 Ver&shy;tex’s sick&shy;le cell gene ther&shy;a&shy;py ap&shy;proved for kids : Cas&shy;gevy may now be used to treat ei&shy;ther sick&shy;le cell dis&shy;ease with … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: 🧬 Vertex’s sickle cell gene therapy approved for kids: Casgevy may now be used to treat either sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia patients as young as ...
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M

Plus more from Lonza, Icosagen and others. 🟥 Galderma’s CRL: Galderma has received a complete response letter from the FDA for its relabotulinumtoxinA, a drug being reviewed as a neuromodulator to ...

More: Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M. Plus more from Lonza, Icosagen and others. 🟥 Galderma’s CRL: Galderma has received a complete response letter from the FDA for its relabotulinumtoxinA, a drug being reviewed as a neuromodulator to ...
TL;DR: 🟥 Galderma’s CRL: Galderma has received a complete response letter from the FDA for its relabotulinumtoxinA, a drug being reviewed as a neuromodulator to ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Peptistar Began Operation of the Asahi Kasei FO-MD System at Manufacturing Scale

FO utilizes an osmotic pressure difference across a membrane to remove water from liquids, achieving highly concentrated API solutions under mild conditions. MD leverages a vapor pressure difference across a membrane. The post Peptistar Began Operation of the Asahi Kasei FO-MD System at Manufacturing Scale appeared first on GEN - Genetic Engineering and Biotechnology News .

More: FO utilizes an osmotic pressure difference across a membrane to remove water from liquids, achieving highly concentrated API solutions under mild conditions. MD leverages a vapor pressure difference across a membrane. The post Peptistar Began Operation of the Asahi Kasei FO-MD System at Manufacturing Scale appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Peptistar Began Operation of the Asahi Kasei FO-MD System at Manufacturing Scale appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Fosun pays $32M to join Lilly and Novartis in fiercely competitive psoriasis market

A Fosun Pharma subsidiary has paid Junshi Biosciences 215 million yuan ($32 million) for Chinese rights to a near-approval autoimmune disease drug candidate.

TL;DR: A Fosun Pharma subsidiary has paid Junshi Biosciences 215 million yuan ($32 million) for Chinese rights to a near-approval autoimmune disease drug candidate.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Roche orchestrates phase 3 KRAS lung cancer win over Amgen, BMS

Roche’s investigational KRAS G12C inhibitor has beaten Amgen’s Lumakras and Bristol Myers Squibb’s Krazati in a phase 3 trial, furthering its ambitions to establish divarasib as a new standard of care.

TL;DR: Roche’s investigational KRAS G12C inhibitor has beaten Amgen’s Lumakras and Bristol Myers Squibb’s Krazati in a phase 3 trial, furthering its ambitions to establish divarasib as a new standard of care.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Roche’s lung cancer pill beats rivals in head-to-head Phase 3 study 

Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit over these medicines is ...

More: Roche’s lung cancer pill beats rivals in head-to-head Phase 3 study . Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial. Full data haven't yet emerged, but if the drug's survival benefit over these medicines is ...
TL;DR: Roche’s lung cancer drug candidate divarasib has beaten marketed drugs from Amgen and Bristol Myers Squibb in a head-to-head trial.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Ex-iTeos CEO starts fresh at GSK neuro partner; Genentech loses yet another key scientist

→ Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments. Balice-Gordon will slide over to ...

More: Ex-iTeos CEO starts fresh at GSK neuro partner; Genentech loses yet another key scientist. → Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments. Balice-Gordon will slide over to ...
TL;DR: → Michel Detheux has succeeded Rita Balice-Gordon as CEO of Danish neuro biotech Muna Therapeutics, which is partnering with GSK on Alzheimer’s treatments.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

BrightGene looks to the West as obesity shot nears China approval

Armed with impressive Phase 3 data, BrightGene is taking its obesity shot to Chinese regulators. It expects trial data in the West to be even stronger, but its search for a partner for ex-China territories ...

More: BrightGene looks to the West as obesity shot nears China approval. Armed with impressive Phase 3 data, BrightGene is taking its obesity shot to Chinese regulators. It expects trial data in the West to be even stronger, but its search for a partner for ex-China territories ...
TL;DR: Armed with impressive Phase 3 data, BrightGene is taking its obesity shot to Chinese regulators.
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Insilico keeps partnership sprint apace in $600M biobucks collab with Takeda

Insilico Medicine has signed a deal worth up to $600 million with Japanese Big Pharma Takeda to collaborate on discovery of assets across Takeda’s therapeutic areas of interest.

TL;DR: Insilico Medicine has signed a deal worth up to $600 million with Japanese Big Pharma Takeda to collaborate on discovery of assets across Takeda’s therapeutic areas of interest.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

First 3D Structure of Malaria’s “Moving Junction” Solves Infection Mystery

Scientists visualized how the malaria parasite gains entry into RBCs through the ring-shaped moving junction, finding that the structure actively remodels the host cell’s membrane, and also confirming that binders to the moving junction can block the parasite’s ability to invade host cells. The post First 3D Structure of Malaria’s “Moving Junction” Solves Infection Mystery appeared first on GEN - Genetic Engineering and Biotechnology News .

More: First 3D Structure of Malaria’s “Moving Junction” Solves Infection Mystery. Scientists visualized how the malaria parasite gains entry into RBCs through the ring-shaped moving junction, finding that the structure actively remodels the host cell’s membrane, and also confirming that binders to the moving junction can block the parasite’s ability to invade host cells.
TL;DR: The post First 3D Structure of Malaria’s “Moving Junction” Solves Infection Mystery appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

In Huntington’s Mouse, Optogenetic Activation of VIP Neurons Restores Brain Function

Researchers identified VIP inhibitory neurons in Huntington’s disease and used optogenetics to restore motor neuron activity in mice, revealing a promising brain circuit target for future therapies. The post In Huntington’s Mouse, Optogenetic Activation of VIP Neurons Restores Brain Function appeared first on GEN - Genetic Engineering and Biotechnology News .

More: In Huntington’s Mouse, Optogenetic Activation of VIP Neurons Restores Brain Function. Researchers identified VIP inhibitory neurons in Huntington’s disease and used optogenetics to restore motor neuron activity in mice, revealing a promising brain circuit target for future therapies.
TL;DR: The post In Huntington’s Mouse, Optogenetic Activation of VIP Neurons Restores Brain Function appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Biological Order Emerges from Tissue Boundaries, Drives Embryo Development

The edges of biological tissues create boundaries that help cells position in a magnet-like manner, giving order to developing embryos. The post Biological Order Emerges from Tissue Boundaries, Drives Embryo Development appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Biological Order Emerges from Tissue Boundaries, Drives Embryo Development. The edges of biological tissues create boundaries that help cells position in a magnet-like manner, giving order to developing embryos. The post Biological Order Emerges from Tissue Boundaries, Drives Embryo Development appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Biological Order Emerges from Tissue Boundaries, Drives Embryo Development appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Merck scraps a Phase 2 Alzheimer's asset from partner Neuphoria

Merck has axed a Phase 2 trial testing an experimental Alzheimer’s medicine, Endpoints News has learned. The company terminated a mid-stage test of the oral drug candidate MK-1167, a Merck spokesperson ...

More: Merck scraps a Phase 2 Alzheimer's asset from partner Neuphoria. Merck has axed a Phase 2 trial testing an experimental Alzheimer’s medicine, Endpoints News has learned. The company terminated a mid-stage test of the oral drug candidate MK-1167, a Merck spokesperson ...
TL;DR: Merck has axed a Phase 2 trial testing an experimental Alzheimer’s medicine, Endpoints News has learned.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

FDA warns Genzyme's Irish site over quality questions

An FDA warning letter sent late last month to Genzyme's Ireland-based manufacturing site, now owned by Sanofi, raises significant quality- and data-related issues. On data integrity, the warning letter dated June ...

More: An FDA warning letter sent late last month to Genzyme's Ireland-based manufacturing site, now owned by Sanofi, raises significant quality- and data-related issues. On data integrity, the warning letter dated June ...
TL;DR: An FDA warning letter sent late last month to Genzyme's Ireland-based manufacturing site, now owned by Sanofi, raises significant quality- and data-related issues.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Merck halts ph. 2 Alzheimer’s trial after Neuphoria small molecule underwhelms

Merck & Co. has nixed the phase 2 study of a potential Alzheimer’s disease medicine after the drug underwhelmed in an interim analysis, marking another blow for the pharma’s struggling partner Neuphoria Therapeutics.

TL;DR: has nixed the phase 2 study of a potential Alzheimer’s disease medicine after the drug underwhelmed in an interim analysis, marking another blow for the pharma’s struggling partner Neuphoria Therapeutics.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Zimmer Biomet buys non-drug pain relief system from Pacira for up to $140M

Pacira BioSciences offloaded its cold-therapy pain relief device to medtech orthopedics specialist Zimmer Biomet in a deal valued at up to $140 million.

TL;DR: Pacira BioSciences offloaded its cold-therapy pain relief device to medtech orthopedics specialist Zimmer Biomet in a deal valued at up to $140 million.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Digitize or Fall Behind

Autolomous CEO Alexander Seyf warns that bioprocessing’s biggest obstacle is not science but data. He argues that digitization, collaboration, and sharing lessons from failed experiments are essential to accelerating innovation in cell and gene therapy. The post Digitize or Fall Behind appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Autolomous CEO Alexander Seyf warns that bioprocessing’s biggest obstacle is not science but data. He argues that digitization, collaboration, and sharing lessons from failed experiments are essential to accelerating innovation in cell and gene therapy. The post Digitize or Fall Behind appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Digitize or Fall Behind appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Standardizing Personalized CRISPR Gene-Editing Therapies

Successfully treating Baby KJ with a personalized CRISPR gene-editing therapy is spurring the industry to investigate how to develop standardized manufacturing platforms as well as how individualized gene-editing products will be regulated. The post Standardizing Personalized CRISPR Gene-Editing Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Standardizing Personalized CRISPR Gene-Editing Therapies. Successfully treating Baby KJ with a personalized CRISPR gene-editing therapy is spurring the industry to investigate how to develop standardized manufacturing platforms as well as how individualized gene-editing products will be regulated.
TL;DR: The post Standardizing Personalized CRISPR Gene-Editing Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Blueprint to Fill the Manufacturing Talent Gap

Manus’ new biomanufacturing apprentice program is designed as a blueprint to share with the industry, delivering in-depth, hands-on training and industry-ready work skills in only six months. The post Blueprint to Fill the Manufacturing Talent Gap appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Blueprint to Fill the Manufacturing Talent Gap. Manus’ new biomanufacturing apprentice program is designed as a blueprint to share with the industry, delivering in-depth, hands-on training and industry-ready work skills in only six months. The post Blueprint to Fill the Manufacturing Talent Gap appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Blueprint to Fill the Manufacturing Talent Gap appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Trait Combining Key to More Effective Vector Production Hosts

Currently available cell lines used to make viral vectors for gene therapy production have significant shortcomings, according to new analysis, which suggests efforts to develop alternatives should focus on engineering potential hosts and fine-tuning cultures. The post Trait Combining Key to More Effective Vector Production Hosts appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Trait Combining Key to More Effective Vector Production Hosts. Currently available cell lines used to make viral vectors for gene therapy production have significant shortcomings, according to new analysis, which suggests efforts to develop alternatives should focus on engineering potential hosts and fine-tuning cultures.
TL;DR: The post Trait Combining Key to More Effective Vector Production Hosts appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

FDA approves Orca Bio’s cell therapy to improve transplant outcomes

The FDA gave the go-ahead to Orca Bio’s T cell therapy that would reduce transplant-related complications for blood cancer patients. The therapy will be branded as Tregzi, an homage to the regulatory T cells, or ...

More: FDA approves Orca Bio’s cell therapy to improve transplant outcomes. The FDA gave the go-ahead to Orca Bio’s T cell therapy that would reduce transplant-related complications for blood cancer patients. The therapy will be branded as Tregzi, an homage to the regulatory T cells, or ...
TL;DR: The FDA gave the go-ahead to Orca Bio’s T cell therapy that would reduce transplant-related complications for blood cancer patients.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

BridgeBio adds $1B as it prepares three more drug launches

BridgeBio Pharma has reloaded with about $1 billion in a preferred equity deal to bolster its reserves ahead of three potential drug launches over the next year. The California biotech, which for years has found ...

More: BridgeBio Pharma has reloaded with about $1 billion in a preferred equity deal to bolster its reserves ahead of three potential drug launches over the next year. The California biotech, which for years has found ...
TL;DR: BridgeBio Pharma has reloaded with about $1 billion in a preferred equity deal to bolster its reserves ahead of three potential drug launches over the next year.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Biotechs ‘in better position to avoid workforce reductions’ as layoffs continue to ease in Q2’26

A sharp reduction in layoffs continued in the second quarter, extending a trend that started last fall.

More: Biotechs ‘in better position to avoid workforce reductions’ as layoffs continue to ease in Q2’26. A sharp reduction in layoffs continued in the second quarter, extending a trend that started last fall.
TL;DR: A sharp reduction in layoffs continued in the second quarter, extending a trend that started last fall.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

92Bio revives a T cell engager it had transferred to Amgen

embargo for wednesday; time tbd; see Kyle A small California startup is reviving an experimental T cell engager that its scientists originally developed but had handed off to Amgen years ago. After repeatedly saying it ...

More: A small Cal&shy;i&shy;for&shy;nia start&shy;up is re&shy;viv&shy;ing an ex&shy;per&shy;i&shy;men&shy;tal T cell en&shy;gager that its sci&shy;en&shy;tists orig&shy;i&shy;nal&shy;ly de&shy;vel&shy;oped but had hand&shy;ed off to Am&shy;gen years ago. Af&shy;ter … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: embargo for wednesday; time tbd; see Kyle A small California startup is reviving an experimental T cell engager that its scientists originally developed but had handed off to Amgen years ago.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Angitia ends Phase 3 in disc disease; Abivax raises $800M on colitis data

🩻 Angitia Biopharmaceuticals drops Phase 3: The US and China biotech terminated a late-stage trial of AGA111 in patients with degenerative disc disease who had a lumbar interbody fusion, according to an

More: 🩻 An&shy;gi&shy;tia Bio&shy;phar&shy;ma&shy;ceu&shy;ti&shy;cals drops Phase 3: The US and Chi&shy;na biotech ter&shy;mi&shy;nat&shy;ed a late-stage tri&shy;al of AGA111 in pa&shy;tients with de&shy;gen&shy;er&shy;a&shy;tive disc dis&shy;ease who had … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: 🩻 Angitia Biopharmaceuticals drops Phase 3: The US and China biotech terminated a late-stage trial of AGA111 in patients with degenerative disc disease who had a lumbar interbody fusion, according to an
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Ipsen gets the Memo, penning €700M deal to buy rare disease biotech for clinical-stage asset

Ipsen is on a roll this week, scooping up its second biotech in three days in order to firm up its pipeline with promising clinical-stage candidates.

TL;DR: Ipsen is on a roll this week, scooping up its second biotech in three days in order to firm up its pipeline with promising clinical-stage candidates.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Ipsen to scoop up Memo Therapeutics and its kidney infection drug

Ipsen is on an M&A roll. The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...

More: Ipsen is on an M&A roll. The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...
TL;DR: The French drugmaker announced its second deal of the week, saying it would buy Memo Therapeutics and its drug candidate called potravitug for a viral ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

A June flourish lifts biotech megaround tally in first half of 2026

Forty private biotech companies disclosed funding rounds of $100 million or more in the first half of 2026, according to an Endpoints News tally. That's more than the same period of 2025 ...

More: Forty private biotech companies disclosed funding rounds of $100 million or more in the first half of 2026, according to an Endpoints News tally. That's more than the same period of 2025 ...
TL;DR: Forty private biotech companies disclosed funding rounds of $100 million or more in the first half of 2026, according to an Endpoints News tally.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Backed by top-tier VCs, stealthy biotech bags AlzeCure Alzheimer’s asset in $2.2B deal

QuantumCell has licensed AlzeCure Pharma’s Alzheimer’s disease platform and lead asset for $12 million upfront, bagging a potentially symptom-relieving drug candidate that is on the cusp of phase 2.

TL;DR: QuantumCell has licensed AlzeCure Pharma’s Alzheimer’s disease platform and lead asset for $12 million upfront, bagging a potentially symptom-relieving drug candidate that is on the cusp of phase 2.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Cytiva Completes Doubling of Utah Site’s Liquid Media Production Capacity

In a wide-ranging interview, Pierre-Alain Ruffieux, Cytiva’s group executive, bioprocess, discusses completion of the doubling of the company’s liquid media production capacity in Logan, UT, Cytiva's approach to artificial intelligence, the FDA’s Advanced Manufacturing Technology (AMT) designation granted for Cytiva’s Elevecta™ transient cell line for adeno-associated virus (AAV) manufacturing, an expanded collaboration with Chinese CDMO Chime Biologics, and the "tailwind" wrought by reshoring of biopharma manufacturing in the United States and Europe. The post Cytiva Completes Doubling of Utah Site’s Liquid Media Production Capacity appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Cytiva Completes Doubling of Utah Site’s Liquid Media Production Capacity. In a wide-ranging interview, Pierre-Alain Ruffieux, Cytiva’s group executive, bioprocess, discusses completion of the doubling of the company’s liquid media production capacity in Logan, UT, Cytiva's approach to artificial intelligence, the FDA’s Advanced Manufacturing Technology (AMT) designation grant…
TL;DR: The post Cytiva Completes Doubling of Utah Site’s Liquid Media Production Capacity appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Can We Outrun Cancer's Evolution? Why BrYet Is Targeting Cancer-Specific Phenotypes

Genetic instability makes metastatic cancer largely incurable. BrYet aims to work around it with a new approach targeting cancer-specific phenotypes.

More: Can We Outrun Cancer's Evolution? Why BrYet Is Targeting Cancer-Specific Phenotypes. BrYet aims to work around it with a new approach targeting cancer-specific phenotypes.
TL;DR: Genetic instability makes metastatic cancer largely incurable.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Bain-backed bone specialist Angitia drops lead spinal fusion candidate

Coming on the heels of a $130 million fundraising round just four months ago, bone-focused Angitia Biopharmaceuticals has pivoted away from its lead asset to structure its pipeline around two earlier-stage drug candidates.

TL;DR: Coming on the heels of a $130 million fundraising round just four months ago, bone-focused Angitia Biopharmaceuticals has pivoted away from its lead asset to structure its pipeline around two earlier-stage drug candidates.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Claude Science is Here, Antibiotics Designed by Text Prompt Among Applications

Anthropic has released Claude Science, an AI workbench for scientists that consolidates fragmented research tools into a single reasoning layer. Basecamp Research’s antibiotic design and vaccine prediction AI models are now available through the platform. The post Claude Science is Here, Antibiotics Designed by Text Prompt Among Applications appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Anthropic has released Claude Science, an AI workbench for scientists that consolidates fragmented research tools into a single reasoning layer. Basecamp Research’s antibiotic design and vaccine prediction AI models are now available through the platform.
TL;DR: The post Claude Science is Here, Antibiotics Designed by Text Prompt Among Applications appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

iPSC-Derived Retinal Endothelial Cells Offer Platform for Studying Diseases

Biomedical engineers at Duke University have for the first time used induced pluripotent stem cells (iPSCs) to grow specialized blood vessel cells critical to retinal health.

More: iPSC-Derived Retinal Endothelial Cells Offer Platform for Studying Diseases. When injected into mouse models of retinal disease, these “retinal endothelial cells” (iRECs) integrated into the damaged tissue to regenerate blood vessels and restore retinal function.
TL;DR: Biomedical engineers at Duke University have for the first time used induced pluripotent stem cells (iPSCs) to grow specialized blood vessel cells critical to retinal health.
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

FDA reviewers oppose allowing seven peptides for compounding

Ahead of an FDA advisory committee meeting to discuss lifting restrictions on seven popular peptides, agency reviewers have recommended against including the peptides on a list of bulk drug substances that can be used for ...

More: Ahead of an FDA ad&shy;vi&shy;so&shy;ry com&shy;mit&shy;tee meet&shy;ing to dis&shy;cuss lift&shy;ing re&shy;stric&shy;tions on sev&shy;en pop&shy;u&shy;lar pep&shy;tides, agency re&shy;view&shy;ers have rec&shy;om&shy;mend&shy;ed against in&shy;clud&shy;ing the pep&shy;tides on a … Get free access to a limited number of articles, plus choose newsletters to get straight to you…
TL;DR: Ahead of an FDA advisory committee meeting to discuss lifting restrictions on seven popular peptides, agency reviewers have recommended against including the peptides on a list of bulk drug substances that can be used for ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Anthropic debuts Claude Science, an AI product for bioscience

Anthropic upended software programming with the runaway success of the coding agent Claude Code. For its next act, the AI lab is turning its attention to biopharma. On Tuesday, Anthropic announced Claude Science, a new ...

More: Anthropic debuts Claude Science, an AI product for bioscience. For its next act, the AI lab is turning its attention to biopharma. On Tuesday, Anthropic announced Claude Science, a new ...
TL;DR: Anthropic upended software programming with the runaway success of the coding agent Claude Code.
Read original at Endpoints
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Eli Lilly, Fujifilm among seven selected for FDA’s PreCheck pilot

The FDA has chosen the first seven companies to participate in its pilot PreCheck program, a group that includes large drugmakers Eli Lilly and Regeneron and manufacturers Cellares and Fujifilm. Kriya Therapeutics, Amneal Pharmaceuticals and ...

More: The FDA has cho&shy;sen the first sev&shy;en com&shy;pa&shy;nies to par&shy;tic&shy;i&shy;pate in its pi&shy;lot PreCheck pro&shy;gram, a group that in&shy;cludes large drug&shy;mak&shy;ers Eli Lil&shy;ly and Re&shy;gen&shy;eron … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA has chosen the first seven companies to participate in its pilot PreCheck program, a group that includes large drugmakers Eli Lilly and Regeneron and manufacturers Cellares and Fujifilm.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

AbbVie and Genmab's latest win brings Epkinly closer to label expansion

AbbVie and Genmab’s bispecific antibody Epkinly succeeded in combination with a widely used cancer drug, bringing it one step closer to a potential label expansion in diffuse large B-cell lymphoma. In the US, Epkinly and ...

More: Ab&shy;b&shy;Vie and Gen&shy;mab’s bis&shy;pe&shy;cif&shy;ic an&shy;ti&shy;body Ep&shy;kin&shy;ly suc&shy;ceed&shy;ed in com&shy;bi&shy;na&shy;tion with a wide&shy;ly used can&shy;cer drug, bring&shy;ing it one step clos&shy;er to a po&shy;ten&shy;tial la&shy;bel ex&shy;pan&shy;sion … Get free access to a limited number of articles, plus choose newsletters to get straight to y…
TL;DR: AbbVie and Genmab’s bispecific antibody Epkinly succeeded in combination with a widely used cancer drug, bringing it one step closer to a potential label expansion in diffuse large B-cell lymphoma.
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Abivax aims to set cancer concerns with ulcerative colitis drug to rest

Late on Monday, Abivax released new trial data on its ulcerative colitis candidate, showing that cancer cases in a Phase 3 trial were within the expected range for these patients. The company says it is ...

More: Late on Mon&shy;day, Abi&shy;vax re&shy;leased new tri&shy;al da&shy;ta on its ul&shy;cer&shy;a&shy;tive col&shy;i&shy;tis can&shy;di&shy;date, show&shy;ing that can&shy;cer cas&shy;es in a Phase 3 tri&shy;al were with&shy;in the … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Late on Monday, Abivax released new trial data on its ulcerative colitis candidate, showing that cancer cases in a Phase 3 trial were within the expected range for these patients.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Health AI caution crosses into confidence

How people in health tech feel about AI in healthcare has changed drastically from just a year ago. Each year, health tech venture firm Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan Mangini survey ...

More: Health AI caution crosses into confidence. How people in health tech feel about AI in healthcare has changed drastically from just a year ago. Each year, health tech venture firm Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan Mangini survey ...
TL;DR: How people in health tech feel about AI in healthcare has changed drastically from just a year ago.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

FDA's acting director of cell and gene therapies to leave position

Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the FDA, he told Endpoints News on Tuesday. Kumar said he ...

More: Vi&shy;jay Ku&shy;mar is leav&shy;ing his role as act&shy;ing di&shy;rec&shy;tor of CBER’s Of&shy;fice of Ther&shy;a&shy;peu&shy;tic Prod&shy;ucts and will soon con&shy;sid&shy;er op&shy;tions both in&shy;side and out&shy;side the … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the FDA, he told Endpoints News on Tuesday.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO

Plus news about Deerfield, InflaRx, Praxis, Nuvectis, Pyxis Oncology, Vistagen, Arcutis Biotherapeutics and Nxera. 🔎 FDA to decide on future of Sarepta exon skipping drugs by end of February: The FDA’s decision date will be ...

More: Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO. Plus news about Deerfield, InflaRx, Praxis, Nuvectis, Pyxis Oncology, Vistagen, Arcutis Biotherapeutics and Nxera. 🔎 FDA to decide on future of Sarepta exon skipping drugs by end of February: The FDA’s decision date will be ...
TL;DR: 🔎 FDA to decide on future of Sarepta exon skipping drugs by end of February: The FDA’s decision date will be ...
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

FDA gene therapy regulator Vijay Kumar steps down from leadership role

Vijay Kumar, the acting head of the FDA office that oversees new gene therapies, is stepping down from his role after a year in the job.

TL;DR: Vijay Kumar, the acting head of the FDA office that oversees new gene therapies, is stepping down from his role after a year in the job.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Vistagen fails another phase 3 social anxiety trial but spies path to market

Vistagen’s social anxiety disorder drug candidate has flunked another phase 3 trial. But, with a post hoc subpopulation analysis linking fasedienol to a nominally statistically significant improvement, the biotech plans to talk to the FDA about a path to approval built around a single future phase 3 study and confirmatory evidence from its broader PALISADE program.

More: Vistagen fails another phase 3 social anxiety trial but spies path to market. Vistagen’s social anxiety disorder drug candidate has flunked another phase 3 trial. But, with a post hoc subpopulation analysis linking fasedienol to a nominally statistically significant improvement, the biotech plans to talk to the FDA about a path to approval built around a single future phase 3…
TL;DR: Vistagen’s social anxiety disorder drug candidate has flunked another phase 3 trial.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

China approved the world’s first solid tumor CAR-T therapy. When will the US follow?

CAR-T cell therapy has flourished since it was first used in 2010, leading to eight approved medicines for different blood cancers. But adapting the powerful technique, which involves engineering a patient’s own T cells to fight cancer, to solid tumors has proven a vexing challenge.

More: China approved the world’s first solid tumor CAR-T therapy. CAR-T cell therapy has flourished since it was first used in 2010, leading to eight approved medicines for different blood cancers. But adapting the powerful technique, which involves engineering a patient’s own T cells to fight cancer, to solid tumors has proven a vexing challenge.
TL;DR: CAR-T cell therapy has flourished since it was first used in 2010, leading to eight approved medicines for different blood cancers.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

How mental health chatbots are trained on therapy sessions

As people increasingly turn to AI for everyday tasks, companionship and emotional assurance, virtual mental health companies once wary of AI are racing to build out their own chatbots to stay competitive ...

More: As peo&shy;ple in&shy;creas&shy;ing&shy;ly turn to AI for every&shy;day tasks, com&shy;pan&shy;ion&shy;ship and emo&shy;tion&shy;al as&shy;sur&shy;ance, vir&shy;tu&shy;al men&shy;tal health com&shy;pa&shy;nies once wary of AI are rac&shy;ing to Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: As people increasingly turn to AI for everyday tasks, companionship and emotional assurance, virtual mental health companies once wary of AI are racing to build out their own chatbots to stay competitive ...
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Unicycive gets second CRL for kidney drug as manufacturing woes continue

Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug oxylanthanum carbonate (OLC) was being reviewed as ...

More: Unicycive gets second CRL for kidney drug as manufacturing woes continue. Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug oxylanthanum carbonate (OLC) was being reviewed as ...
TL;DR: Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

New Agentic Capabilities for Tasks Across the Complete Research Workflow

Officials at Elsevier say the company is expanding LeapSpace, a research-grade AI workspace, with new agentic capabilities that help “researchers carry out an even greater range of tasks within their complex workflow to drive better outcomes with confidence.” The post New Agentic Capabilities for Tasks Across the Complete Research Workflow appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Officials at Elsevier say the company is expanding LeapSpace, a research-grade AI workspace, with new agentic capabilities that help “researchers carry out an even greater range of tasks within their complex workflow to drive better outcomes with confidence.
TL;DR: Officials at Elsevier say the company is expanding LeapSpace, a research-grade AI workspace, with new agentic capabilities that help “researchers carry out an even greater range of tasks within their complex workflow to drive better outcomes with confidence.” The post New Agentic Capabilities for Tasks Across the Complete Research Workflow appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Deerfield’s Boulevard Bio pens $1.6B deal for trispecific TCE from China’s Metis TechBio

U.S.-based Boulevard Bio is paying $20 million upfront to China’s Metis TechBio for the global rights to a trispecific T-cell engager for autoimmune diseases.

TL;DR: U.S.-based Boulevard Bio is paying $20 million upfront to China’s Metis TechBio for the global rights to a trispecific T-cell engager for autoimmune diseases.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Sanofi’s Lumizyme successor passes Phase 3 test in babies with Pompe disease

Sanofi said its enzyme replacement therapy succeeded in a registrational trial in a severe form of Pompe disease, paving the way for a key label expansion in the US. The French pharma is looking to ...

More: Sanofi’s Lumizyme successor passes Phase 3 test in babies with Pompe disease. Sanofi said its enzyme replacement therapy succeeded in a registrational trial in a severe form of Pompe disease, paving the way for a key label expansion in the US. The French pharma is looking to ...
TL;DR: Sanofi said its enzyme replacement therapy succeeded in a registrational trial in a severe form of Pompe disease, paving the way for a key label expansion in the US.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

BeOne’s Brukinsa succeeds in frontline mantle cell lymphoma study

BeOne Medicines said its BTK inhibitor Brukinsa cut the risk of disease progression or death by 43% compared to chemoimmunotherapy when used as a first option for mantle cell lymphoma patients. The Phase 3 study ...

More: BeOne Med&shy;i&shy;cines said its BTK in&shy;hibitor Brukin&shy;sa cut the risk of dis&shy;ease pro&shy;gres&shy;sion or death by 43% com&shy;pared to chemoim&shy;munother&shy;a&shy;py when used as a first … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: BeOne Medicines said its BTK inhibitor Brukinsa cut the risk of disease progression or death by 43% compared to chemoimmunotherapy when used as a first option for mantle cell lymphoma patients.
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

House China panel probes Bristol Myers, Pfizer on use of trial sites

A congressional committee has opened an inquiry into Bristol Myers Squibb and Pfizer's use of clinical trial sites in China, including facilities that the committee's chairman said are affiliated with the Chinese military or that ...

More: A con&shy;gres&shy;sion&shy;al com&shy;mit&shy;tee has opened an in&shy;quiry in&shy;to Bris&shy;tol My&shy;ers Squibb and Pfiz&shy;er’s use of clin&shy;i&shy;cal tri&shy;al sites in Chi&shy;na, in&shy;clud&shy;ing fa&shy;cil&shy;i&shy;ties that the com&shy;mit&shy;tee’s … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: A congressional committee has opened an inquiry into Bristol Myers Squibb and Pfizer's use of clinical trial sites in China, including facilities that the committee's chairman said are affiliated with the Chinese military or that ...
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Praxis faces FDA decision delay as analysts point finger at agency layoffs

The FDA has delayed a decision on the approval of Praxis Precision Medicine’s rare epilepsy prospect by three months. TD Cowen analysts said they “strongly believe FDA bandwidth constraints from last year’s agency downsizing likely contributed to the delay.”

More: Praxis faces FDA decision delay as analysts point finger at agency layoffs. The FDA has delayed a decision on the approval of Praxis Precision Medicine’s rare epilepsy prospect by three months. TD Cowen analysts said they “strongly believe FDA bandwidth constraints from last year’s agency downsizing likely contributed to the delay.”
TL;DR: The FDA has delayed a decision on the approval of Praxis Precision Medicine’s rare epilepsy prospect by three months.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Opinion: Florida is the first state to require EKGs for high school athletes. It’s a mistake

“There are better ways for schools to protect student athletes,” writes Katherine Hofmann.

More: Opinion: Florida is the first state to require EKGs for high school athletes. It’s a mistake. “There are better ways for schools to protect student athletes,” writes Katherine Hofmann.
TL;DR: “There are better ways for schools to protect student athletes,” writes Katherine Hofmann.
Read original at Statnews
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Two Proteins with Opposing Functions Found to Support Healthy Skin Maintenance

Researchers identified two ubiquitin-like proteins, NEDD8 and SUMO2, that play opposing roles in healthy skin maintenance, and could form the basis of new strategies for treating skin conditions and potentially slowing cancer. The post Two Proteins with Opposing Functions Found to Support Healthy Skin Maintenance appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Two Proteins with Opposing Functions Found to Support Healthy Skin Maintenance. Researchers identified two ubiquitin-like proteins, NEDD8 and SUMO2, that play opposing roles in healthy skin maintenance, and could form the basis of new strategies for treating skin conditions and potentially slowing cancer.
TL;DR: The post Two Proteins with Opposing Functions Found to Support Healthy Skin Maintenance appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Schistosomiasis Vaccine Shows Strong Immune Memory in Early Clinical Trials

The experimental SchistoShield vaccine, against schistosomiasis, triggered strong B-cell and T-cell immune memory in early U.S. and African clinical trials, marking a promising step toward preventing and treating the parasitic infection. The post Schistosomiasis Vaccine Shows Strong Immune Memory in Early Clinical Trials appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Schistosomiasis Vaccine Shows Strong Immune Memory in Early Clinical Trials. The experimental SchistoShield vaccine, against schistosomiasis, triggered strong B-cell and T-cell immune memory in early U.S. and African clinical trials, marking a promising step toward preventing and treating the parasitic infection.
TL;DR: The post Schistosomiasis Vaccine Shows Strong Immune Memory in Early Clinical Trials appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Iron Accumulation Drives Neurodegeneration via Chronic Stress Pathway

Iron accumulation is a key target in the effort to predict, prevent, and treat neurodegenerative diseases. A new stress pathway is a promising therapeutic route for boosting neuron resilience. The post Iron Accumulation Drives Neurodegeneration via Chronic Stress Pathway appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Iron Accumulation Drives Neurodegeneration via Chronic Stress Pathway. Iron accumulation is a key target in the effort to predict, prevent, and treat neurodegenerative diseases. A new stress pathway is a promising therapeutic route for boosting neuron resilience.
TL;DR: The post Iron Accumulation Drives Neurodegeneration via Chronic Stress Pathway appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Shilpa Commissions Integrated ADC Drug Substance GMP Manufacturing Facility

The manufacturing of highly potent compounds has been a core pillar of Shilpa’s identity, and this ADC drug substance facility adds a new sophisticated dimension to the Shilpa group’s capabilities. The post Shilpa Commissions Integrated ADC Drug Substance GMP Manufacturing Facility appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Shilpa Commissions Integrated ADC Drug Substance GMP Manufacturing Facility. The manufacturing of highly potent compounds has been a core pillar of Shilpa’s identity, and this ADC drug substance facility adds a new sophisticated dimension to the Shilpa group’s capabilities.
TL;DR: The post Shilpa Commissions Integrated ADC Drug Substance GMP Manufacturing Facility appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

CCRM Ireland Would Be Established to Hasten Translation of Advanced Therapies Into Patient Treatments

The partnership will explore how to advance the design and clinical translation and delivery of personalized immune cell therapies, while also leveraging Ireland’s biopharmaceutical manufacturing skills. The post CCRM Ireland Would Be Established to Hasten Translation of Advanced Therapies Into Patient Treatments appeared first on GEN - Genetic Engineering and Biotechnology News .

More: CCRM Ireland Would Be Established to Hasten Translation of Advanced Therapies Into Patient Treatments. The partnership will explore how to advance the design and clinical translation and delivery of personalized immune cell therapies, while also leveraging Ireland’s biopharmaceutical manufacturing skills.
TL;DR: The post CCRM Ireland Would Be Established to Hasten Translation of Advanced Therapies Into Patient Treatments appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

BioCryst ends internal discovery programs, will close Alabama research facility

BioCryst Pharmaceuticals is winding down its own drug discovery work, saying that it plans to look for future drug programs externally. The company announced a plan to discontinue its internal discovery ...

More: BioCryst ends internal discovery programs, will close Alabama research facility. BioCryst Pharmaceuticals is winding down its own drug discovery work, saying that it plans to look for future drug programs externally. The company announced a plan to discontinue its internal discovery ...
TL;DR: BioCryst Pharmaceuticals is winding down its own drug discovery work, saying that it plans to look for future drug programs externally.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Evommune's lead drug fails in chronic hives, stock sinks

Evommune's shares {$EVMN} fell more than 30% on Monday morning after the biotech reported its first major trial readout since going public last year. In chronic spontaneous urticaria, a skin condition where patients spontaneously break ...

More: Evommune's lead drug fails in chronic hives, stock sinks. Evommune's shares {$EVMN} fell more than 30% on Monday morning after the biotech reported its first major trial readout since going public last year. In chronic spontaneous urticaria, a skin condition where patients spontaneously break ...
TL;DR: Evommune's shares {$EVMN} fell more than 30% on Monday morning after the biotech reported its first major trial readout since going public last year.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Biotech SPAC deal gets it to Nasdaq; AstraZeneca Phase 3 win in bone disease

Plus news about Alebund Pharmaceuticals, Regenxbio and Neuphoria Therapeutics. 💸 A SPAC!: Talawar Therapeutics will land on the Nasdaq via a combination with blank-check company JATT II Acquisition Corp {$JATT}. The

More: Biotech SPAC deal gets it to Nasdaq; AstraZeneca Phase 3 win in bone disease. Plus news about Alebund Pharmaceuticals, Regenxbio and Neuphoria Therapeutics. 💸 A SPAC!: Talawar Therapeutics will land on the Nasdaq via a combination with blank-check company JATT II Acquisition Corp {$JATT}.
TL;DR: Plus news about Alebund Pharmaceuticals, Regenxbio and Neuphoria Therapeutics.
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

FDA rejects Sobi’s gout drug over manufacturing issues, sparing Amgen blockbuster

Jun 29, 2026 11:04am Sobi gout FDA Complete Response Letter Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA.

More: Jun 29, 2026 11:04am Sobi gout FDA Complete Response Letter Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA. The FDA has issued a complete response letter to Sobi’s application for NASP as a treatment for uncontrolled gout, the Swedish company announced Friday.
TL;DR: Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

BioCryst ends internal discovery programs, closes Alabama facility in pivot to cost-saving partnerships

After scrapping development on its diabetic macular edema treatment avoralstat last month, BioCryst has announced it is shuttering all internal discovery programs to focus on external innovation and partnerships.

More: Jun 29, 2026 10:30am BioCryst Pharmaceuticals layoffs rare diseases hereditary angioedema After scrapping development of its diabetic macular edema treatment avoralstat last month, BioCryst Pharmaceuticals is shuttering all internal discovery programs to focus on external innovation and partnerships.
TL;DR: After scrapping development on its diabetic macular edema treatment avoralstat last month, BioCryst has announced it is shuttering all internal discovery programs to focus on external innovation and partnerships.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Evommune’s phase 2b trial flops, ending challenge to Novartis in hives

A phase 2b trial of Evommune’s EVO756 has missed its primary endpoint, wiping out a would-be rival to Novartis for the chronic spontaneous urticaria market.

More: The trial compared EVO756, an oral MRGPRX2 antagonist, to placebo in adults with moderate-to-severe forms of the skin condition CSU. In September 2025, the Swiss drugmaker  won FDA approval for the BTK inhibitor Rhapsido in CSU, a condition characterized by hives. The biotech plans to start dosing patients in a phase 2b migraine prevention trial imminently.
TL;DR: A phase 2b trial of Evommune’s EVO756 has missed its primary endpoint, wiping out a would-be rival to Novartis for the chronic spontaneous urticaria market.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Post-Hoc: China deals are pharma’s new tax inversions 

About a decade ago, when I had just started covering pharma, one of the biggest stories was tax inversions. For those who don’t remember, tax inversions were a form of M&A in which a US ...

More: Post-Hoc: China deals are pharma’s new tax inversions . About a decade ago, when I had just started covering pharma, one of the biggest stories was tax inversions. For those who don’t remember, tax inversions were a form of M&A in which a US ...
TL;DR: About a decade ago, when I had just started covering pharma, one of the biggest stories was tax inversions.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

United Therapeutics nabs FDA approval for donor-lung assessment device

Jun 29, 2026 9:27am United Therapeutics FDA transplant Devices United Therapeutics has been given a premarket approval (PMA) from the FDA for its LungFX device.

More: Jun 29, 2026 9:27am United Therapeutics FDA transplant Devices United Therapeutics has been given a premarket approval (PMA) from the FDA for its LungFX device. The product can now be used in centralized ex vivo lung perfusion (EVLP). This allows lungs that have been donated for transplant to be looked at and assessed outside the body before being transplanted.
TL;DR: United Therapeutics has been given a premarket approval from the FDA for its LungFX device.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

Roche launches Axelios 1, its eagerly awaited gene sequencing rival to Illumina

Roche may have failed to buy out Illumina back in 2012, but now it’s trying to take up some of the gene sequencing specialist’s market share with its own next-gen platform.

More: Jun 29, 2026 9:03am Roche gene sequencing Diagnostics MedTech Roche may have failed to buy out Illumina back in 2012, but now it’s trying to take up some of the gene sequencing specialist’s market share with its own next-gen platform.
TL;DR: Roche may have failed to buy out Illumina back in 2012, but now it’s trying to take up some of the gene sequencing specialist’s market share with its own next-gen platform.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Tecan Integrates Agentic AI Into Its Introspect Lab Analytics Platform

Agentic AI will allow laboratories to move beyond traditional monitoring and reactive troubleshooting toward proactive actions that help prevent issues before they impact performance, quality, or scientific outcomes. The post Tecan Integrates Agentic AI Into Its Introspect Lab Analytics Platform appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Tecan Integrates Agentic AI Into Its Introspect Lab Analytics Platform. Agentic AI will allow laboratories to move beyond traditional monitoring and reactive troubleshooting toward proactive actions that help prevent issues before they impact performance, quality, or scientific outcomes.
TL;DR: The post Tecan Integrates Agentic AI Into Its Introspect Lab Analytics Platform appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Production problems hamper Lantheus bid for FDA approval of radiopharma dx kit

The FDA dealt Lantheus’ bid to garner approval of its radiodiopharmaceutical diagnostic kit a setback due to manufacturing issues at a third-party facility.

More: Jun 29, 2026 8:31am FDA response letter Lantheus radiopharmaceuticals diagnostics The FDA dealt Lantheus’ bid to garner approval of its radiodiopharmaceutical diagnostic kit a setback due to manufacturing issues at a third-party facility.
TL;DR: The FDA dealt Lantheus’ bid to garner approval of its radiodiopharmaceutical diagnostic kit a setback due to manufacturing issues at a third-party facility.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Cash-strapped Alopexx reignites plans to go public via $30M IPO to fund infectious disease programs

Alopexx has resuscitated its plans for a public listing as the biotech seeks urgently needed funds to advance a pipeline that includes an infectious disease antibody that was once the focus of a $375 million deal with Sanofi.

More: The aim is to list the common stock on the NYSE American exchange under the ticker “ALPX.” The biotech is developing two candidates, both of which target poly N-acetyl glucosamine (PNAG). The company has earmarked $6 million for a proof-of-concept study of a PNAG vaccine dubbed AV0328, which has previously completed a phase 1 trial.
TL;DR: Alopexx has resuscitated its plans for a public listing as the biotech seeks urgently needed funds to advance a pipeline that includes an infectious disease antibody that was once the focus of a $375 million deal with Sanofi.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Ipsen pens $1.7B deal to acquire Kartos for potential Jakafi add-on therapy for myelofibrosis

Ipsen is paying $450 million upfront to buy U.S.-based Kartos Therapeutics for a phase 3-stage blood cancer drug designed to improve Jakafi treatment.

More: The drug is aimed at restoring the function of p53, a critical tumor suppressor in myelofibrosis.  The p53 protein is already well known for its ability to protect against cancer by preventing DNA-damaged cells from replicating. Last year, PMV Pharmaceuticals  reported a 43% response rate in a mid-phase ovarian cancer trial for its p53 reactivator rezatapopt.
TL;DR: Ipsen is paying $450 million upfront to buy U.S.-based Kartos Therapeutics for a phase 3-stage blood cancer drug designed to improve Jakafi treatment.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Ipsen to buy blood cancer company Kartos Therapeutics for $450M upfront

Ipsen is earmarking up to $1.75 billion to take Kartos Therapeutics and its MDM2 protein-targeting drug candidate that it in-licensed from Amgen back in 2016. Ipsen will pay $450 million upfront ...

More: Ipsen is earmarking up to $1.75 billion to take Kartos Therapeutics and its MDM2 protein-targeting drug candidate that it in-licensed from Amgen back in 2016. Ipsen will pay $450 million upfront ...
TL;DR: Ipsen is earmarking up to $1.75 billion to take Kartos Therapeutics and its MDM2 protein-targeting drug candidate that it in-licensed from Amgen back in 2016.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Zymeworks to acquire troubled biotech Theravance in $929M deal

Zymeworks is set to put Theravance Biopharma out of its misery, announcing on Monday that it will buy the biotech for $929 million upfront in cash. In March, Theravance said it was shutting down its ...

More: Zymeworks is set to put Theravance Biopharma out of its misery, announcing on Monday that it will buy the biotech for $929 million upfront in cash. In March, Theravance said it was shutting down its ...
TL;DR: Zymeworks is set to put Theravance Biopharma out of its misery, announcing on Monday that it will buy the biotech for $929 million upfront in cash.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Sobi receives CRL for gout combination drug over manufacturing 

The FDA has issued Sobi, also known as Swedish Orphan Biovitrum, a complete response letter for its combination gout treatment over production concerns and issues with its third-party manufacturing sites. The agency has requested additional ...

More: The FDA has is&shy;sued So&shy;bi, al&shy;so known as Swedish Or&shy;phan Biovit&shy;rum, a com&shy;plete re&shy;sponse let&shy;ter for its com&shy;bi&shy;na&shy;tion gout treat&shy;ment over pro&shy;duc&shy;tion con&shy;cerns and is&shy;sues … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA has issued Sobi, also known as Swedish Orphan Biovitrum, a complete response letter for its combination gout treatment over production concerns and issues with its third-party manufacturing sites.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

AstraZeneca unveils phase 3 bone disease data behind $5B forecast for Strensiq successor

AstraZeneca has shared the data behind previously disclosed phase 3 rare disease wins, fleshing out the case for a Strensiq successor tipped to generate blockbuster sales. The company has yet to share data from a third trial that missed its primary endpoint.

More: AstraZeneca unveils phase 3 bone disease data behind $5B forecast for Strensiq successor. AstraZeneca has shared the data behind previously disclosed phase 3 rare disease wins, fleshing out the case for a Strensiq successor tipped to generate blockbuster sales. The company has yet to share data from a third trial that missed its primary endpoint.
TL;DR: AstraZeneca has shared the data behind previously disclosed phase 3 rare disease wins, fleshing out the case for a Strensiq successor tipped to generate blockbuster sales.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Insilico, SK Launch Up-to-$2.5B Neuroimmune AI Drug Collaboration

Insilico agreed to apply its Pharma.AI platform, which addresses target validation, generative chemistry, and molecule optimization, along with its preclinical drug discovery expertise to discover, design, and optimize candidates for neuroimmune indications against targets that will originate with SK. SK will contribute its development and clinical capabilities in neuroimmune disorders, steering the late-stage development and commercialization of all resulting programs. The post Insilico, SK Launch Up-to-$2.5B Neuroimmune AI Drug Collaboration appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Insilico agreed to apply its Pharma.AI platform, which addresses target validation, generative chemistry, and molecule optimization, along with its preclinical drug discovery expertise to discover, design, and optimize candidates for neuroimmune indications against targets that will originate with SK.
TL;DR: The post Insilico, SK Launch Up-to-$2.5B Neuroimmune AI Drug Collaboration appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

FDA approves Viridian eye drug, stoking competition with Amgen's Tepezza

The FDA approved Viridian Therapeutics' thyroid eye disease drug veligrotug, kicking off a competition with Amgen’s blockbuster Tepezza. Viridian’s drug, to be marketed as Lumvoa, will be priced “in line with” Tepezza, CEO Steve Mahoney ...

More: FDA approves Viridian eye drug, stoking competition with Amgen's Tepezza. The FDA approved Viridian Therapeutics' thyroid eye disease drug veligrotug, kicking off a competition with Amgen’s blockbuster Tepezza. Viridian’s drug, to be marketed as Lumvoa, will be priced “in line with” Tepezza, CEO Steve Mahoney ...
TL;DR: The FDA approved Viridian Therapeutics' thyroid eye disease drug veligrotug, kicking off a competition with Amgen’s blockbuster Tepezza.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Backed by $165M, Bionyra Pharma Launches to Advance Inflammatory Disease Biologics

The company, which emerged from stealth this week, is using the funds to develop and test three therapeutic assets that it licensed from external partners as well as to progress some additional preclinical assets. The post Backed by $165M, Bionyra Pharma Launches to Advance Inflammatory Disease Biologics appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Backed by $165M, Bionyra Pharma Launches to Advance Inflammatory Disease Biologics. The company, which emerged from stealth this week, is using the funds to develop and test three therapeutic assets that it licensed from external partners as well as to progress some additional preclinical assets.
TL;DR: The post Backed by $165M, Bionyra Pharma Launches to Advance Inflammatory Disease Biologics appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

FDA advisory panels are back, with new meetings for Replimune, Capricor

Under new leadership, FDA officials have said they’ll place renewed emphasis on advisory meetings for contested product applications. Two new announcements suggest they’re making good on that. Replimune and

More: FDA advisory panels are back, with new meetings for Replimune, Capricor. Under new leadership, FDA officials have said they’ll place renewed emphasis on advisory meetings for contested product applications. Two new announcements suggest they’re making good on that.
TL;DR: Under new leadership, FDA officials have said they’ll place renewed emphasis on advisory meetings for contested product applications.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Genome Editing at the Turning Point—Bringing CRISPR to Clinical Reality

This GEN Live show will bring together a panel of leading experts to break down the latest advances, innovations, and challenges shaping genome editing. The post Genome Editing at the Turning Point—Bringing CRISPR to Clinical Reality appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Genome Editing at the Turning Point—Bringing CRISPR to Clinical Reality. This GEN Live show will bring together a panel of leading experts to break down the latest advances, innovations, and challenges shaping genome editing. The post Genome Editing at the Turning Point—Bringing CRISPR to Clinical Reality appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Genome Editing at the Turning Point—Bringing CRISPR to Clinical Reality appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechBioTech PrimerWikipedia

Intravesical CAR T-Cell Therapy Reduces Bladder Cancer Growth in Preclinical Model

Researchers identified the protein MUC16 as a clinically relevant target for bladder cancer, and engineered MUC16-targeting CAR T cells that, when delivered into the bladder via a catheter, controlled bladder tumors in mice. The post Intravesical CAR T-Cell Therapy Reduces Bladder Cancer Growth in Preclinical Model appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Intravesical CAR T-Cell Therapy Reduces Bladder Cancer Growth in Preclinical Model. Researchers identified the protein MUC16 as a clinically relevant target for bladder cancer, and engineered MUC16-targeting CAR T cells that, when delivered into the bladder via a catheter, controlled bladder tumors in mice.
TL;DR: The post Intravesical CAR T-Cell Therapy Reduces Bladder Cancer Growth in Preclinical Model appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Akeso pushes back on ASCO questioning of lung cancer drug

Akeso leadership is pushing back on some of the questions about its next-generation cancer drug raised earlier this month at the annual American Society of Clinical Oncology meeting. In an exclusive interview with Endpoints News ...

More: Akeso leadership is pushing back on some of the questions about its next-generation cancer drug raised earlier this month at the annual American Society of Clinical Oncology meeting. In an exclusive interview with Endpoints News ...
TL;DR: Akeso leadership is pushing back on some of the questions about its next-generation cancer drug raised earlier this month at the annual American Society of Clinical Oncology meeting.
Read original at Endpoints
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Nipah and Hendra Viruses: Antibody Cocktail Provides Complete Protection in Hamster Model

Researchers developed the first human antibody cocktail to completely protect against the lethal Nipah and Hendra virus infection in preclinical models, advancing a promising dual-target strategy for future outbreaks. The post Nipah and Hendra Viruses: Antibody Cocktail Provides Complete Protection in Hamster Model appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Nipah and Hendra Viruses: Antibody Cocktail Provides Complete Protection in Hamster Model. Researchers developed the first human antibody cocktail to completely protect against the lethal Nipah and Hendra virus infection in preclinical models, advancing a promising dual-target strategy for future outbreaks.
TL;DR: The post Nipah and Hendra Viruses: Antibody Cocktail Provides Complete Protection in Hamster Model appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

EU probes Sanofi for alleged smear campaign against rival flu vaccine

The European Commission said it has started an investigation into whether Sanofi flouted competition rules while marketing its enhanced flu vaccine for over 60s, known as Efluelda. The French pharma company may have used “misleading ...

More: The European Commission said it has started an investigation into whether Sanofi flouted competition rules while marketing its enhanced flu vaccine for over 60s, known as Efluelda. The French pharma company may have used “misleading ...
TL;DR: The European Commission said it has started an investigation into whether Sanofi flouted competition rules while marketing its enhanced flu vaccine for over 60s, known as Efluelda.
Read original at Endpoints
Further reading: Genome.govBioRxivGenetic Engineering BasicsWikipedia

Epicrispr gene silencer is 1st drug to boost muscle in form of muscular dystrophy, biotech says

Epicrispr Biotechnologies has used its gene silencing tech to boost muscle mass in three patients with facioscapulohumeral muscular dystrophy, a clinical first for the debilitating disease with no approved treatments.

More: In an ongoing phase 1/2 study , the Bay Area biotech has so far dosed nine patients across two dose cohorts. For three patients given the lower dose, the company’s epigenetic editor, EPI-321, lead to an average increase in lean muscle of about 0.8 pounds, Epicrispr announced today.
TL;DR: Epicrispr Biotechnologies has used its gene silencing tech to boost muscle mass in three patients with facioscapulohumeral muscular dystrophy, a clinical first for the debilitating disease with no approved treatments.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Lycia raises $75M for food allergy and Graves’ disease

Bay Area biotech Lycia Therapeutics is refueling with $75 million for its protein degradation platform co-founded by Nobel laureate Carolyn Bertozzi. The company snagged the Series D from large investors such as Janus Henderson, Balyasny ...

More: Lycia raises $75M for food allergy and Graves’ disease. Bay Area biotech Lycia Therapeutics is refueling with $75 million for its protein degradation platform co-founded by Nobel laureate Carolyn Bertozzi. The company snagged the Series D from large investors such as Janus Henderson, Balyasny ...
TL;DR: Bay Area biotech Lycia Therapeutics is refueling with $75 million for its protein degradation platform co-founded by Nobel laureate Carolyn Bertozzi.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Biogen ends Apellis research programs, cuts ‘small number’ of roles after $5.6B buyout

Biogen isn’t wasting any time integrating its multibillion-dollar purchase of Apellis, revealing plans to part ways with some of the biotech’s staffers and halt work on most of its research programs.

More: Jun 26, 2026 9:56am Biogen Apellis Pharmaceuticals Biotech Biogen isn’t wasting any time integrating its multibillion-dollar purchase of Apellis, revealing plans to part ways with some of the biotech’s staffers and halt work on most of its research programs about one month after closing the deal.
TL;DR: Biogen isn’t wasting any time integrating its multibillion-dollar purchase of Apellis, revealing plans to part ways with some of the biotech’s staffers and halt work on most of its research programs.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

EU regulators recommend revoking the marketing authorization for Amgen’s Tavneos

The European Medicines Agency has proposed revoking the marketing authorization for Amgen’s controversial rare disease drug Tavneos citing “incorrect and misleading” clinical data. The future of Amgen’s Tavneos has been in turmoil after being linked ...

More: The European Medicines Agency has proposed revoking the marketing authorization for Amgen’s controversial rare disease drug Tavneos citing “incorrect and misleading” clinical data. The future of Amgen’s Tavneos has been in turmoil after being linked ...
TL;DR: The European Medicines Agency has proposed revoking the marketing authorization for Amgen’s controversial rare disease drug Tavneos citing “incorrect and misleading” clinical data.
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Moderna enters in vivo CAR-T, granting autoimmune asset ‘007’ license to kill pathogenic cells

Moderna has unveiled its first in vivo CAR-T program. Building on other groups’ ex vivo CAR-T data, the company plans to start clinical development of an off-the-shelf autoimmune disease prospect, dubbed “007,” next year.

More: Moderna enters in vivo CAR-T, granting autoimmune asset ‘007’ license to kill pathogenic cells. Moderna has unveiled its first in vivo CAR-T program. Building on other groups’ ex vivo CAR-T data, the company plans to start clinical development of an off-the-shelf autoimmune disease prospect, dubbed “007,” next year.
TL;DR: Moderna has unveiled its first in vivo CAR-T program.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Circio’s circVec and Tcelltech’s nanoSMAR Technologies Combined to Generate Nextgen In vivo CAR-T and TCR-T Cells

Circio and Tcelltech will combine Circio's circVec circular RNA expression technology with Tcelltech's non-viral, high-cargo capacity nanoSMAR vector platform and evaluate the combination in engineered T cells through staged research. The post Circio’s circVec and Tcelltech’s nanoSMAR Technologies Combined to Generate Nextgen <i>In vivo</i> CAR-T and TCR-T Cells appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Circio’s circVec and Tcelltech’s nanoSMAR Technologies Combined to Generate Nextgen In vivo CAR-T and TCR-T Cells. Circio and Tcelltech will combine Circio's circVec circular RNA expression technology with Tcelltech's non-viral, high-cargo capacity nanoSMAR vector platform and evaluate the combination in engineered T cells through staged research.
TL;DR: The post Circio’s circVec and Tcelltech’s nanoSMAR Technologies Combined to Generate Nextgen <i>In vivo</i> CAR-T and TCR-T Cells appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

How Epicrispr is using 'digital twins' to study a muscle disease therapy

Epicrispr Biotechnologies on Friday shared an early cut of data from its study of an epigenetic editing therapy for a genetic disease that leads to progressive weakening of the skeletal muscles. The Bay Area biotech’s ...

More: Epi&shy;crispr Biotech&shy;nolo&shy;gies on Fri&shy;day shared an ear&shy;ly cut of da&shy;ta from its study of an epi&shy;ge&shy;net&shy;ic edit&shy;ing ther&shy;a&shy;py for a ge&shy;net&shy;ic dis&shy;ease that leads to … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Epicrispr Biotechnologies on Friday shared an early cut of data from its study of an epigenetic editing therapy for a genetic disease that leads to progressive weakening of the skeletal muscles.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

How iBio aims to stand out in obesity by targeting ‘both sides of the equation’ for antibody discovery

Upon finally reaching the clinic, iBio feels vindicated about the artificial intelligence-powered discovery platform it picked up in 2022.

More: How iBio aims to stand out in obesity by targeting ‘both sides of the equation’ for antibody discovery. Upon finally reaching the clinic, iBio feels vindicated about the artificial intelligence-powered discovery platform it picked up in 2022.
TL;DR: Upon finally reaching the clinic, iBio feels vindicated about the artificial intelligence-powered discovery platform it picked up in 2022.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Puerto Rico makes its case as a biotech manufacturing hub

Puerto Rico is building on its pharma manufacturing legacy to attract advanced therapy developers seeking scale, regulatory alignment and speed.

TL;DR: Puerto Rico is building on its pharma manufacturing legacy to attract advanced therapy developers seeking scale, regulatory alignment and speed.
Read original at Fiercebiotech
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

After buying Apellis for $5.6B, Biogen is cutting most of its pipeline work

Biogen has paused or canceled investment in the “majority” of research programs that came with its $5.6 billion acquisition of Apellis Pharmaceuticals and laid off “a small number” of employees from the biotech, a spokesperson ...

More: Bio&shy;gen has paused or can&shy;celed in&shy;vest&shy;ment in the “ma&shy;jor&shy;i&shy;ty” of re&shy;search pro&shy;grams that came with its $5.6 bil&shy;lion ac&shy;qui&shy;si&shy;tion of Apel&shy;lis Phar&shy;ma&shy;ceu&shy;ti&shy;cals and laid off … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Biogen has paused or canceled investment in the “majority” of research programs that came with its $5.6 billion acquisition of Apellis Pharmaceuticals and laid off “a small number” of employees from the biotech, a spokesperson ...
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

AI Framework Surfaces New CAR T Target with Multi‑Cancer Potential

A human‑in‑the‑loop AI framework rapidly nominates CAR T targets, leading to a GPNMB‑directed CAR T cell with activity across melanoma, leukemia, and colorectal cancer in preclinical studies. The post AI Framework Surfaces New CAR T Target with Multi‑Cancer Potential appeared first on GEN - Genetic Engineering and Biotechnology News .

More: AI Framework Surfaces New CAR T Target with Multi‑Cancer Potential. A human‑in‑the‑loop AI framework rapidly nominates CAR T targets, leading to a GPNMB‑directed CAR T cell with activity across melanoma, leukemia, and colorectal cancer in preclinical studies.
TL;DR: The post AI Framework Surfaces New CAR T Target with Multi‑Cancer Potential appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Antibiotics Trigger Protein Sharing Among Bacteria, Aiding Persister Cells

Using a genetic system in E. coli, researchers discovered how bacteria work as a team to survive antibiotics, with donor cells exporting and sharing vesicle-bound proteins with populations of less active persister cells. The post Antibiotics Trigger Protein Sharing Among Bacteria, Aiding Persister Cells appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Antibiotics Trigger Protein Sharing Among Bacteria, Aiding Persister Cells. coli, researchers discovered how bacteria work as a team to survive antibiotics, with donor cells exporting and sharing vesicle-bound proteins with populations of less active persister cells.
TL;DR: Using a genetic system in E.
Read original at Genengnews
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Merck KGaA to Acquire Bio-Techne for $11.3B, Expanding Life Science Tools Presence

The deal would add Bio-Techne’s multiomics offerings, analytical technologies, and integrated workflow solutions to German Merck’s platforms and services in research, bioprocessing and advanced therapeutics, with the aim of creating a combined company capable of helping customers from discovery and translational research through development, testing and commercial manufacturing. The post Merck KGaA to Acquire Bio-Techne for $11.3B, Expanding Life Science Tools Presence appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Merck KGaA to Acquire Bio-Techne for $11.3B, Expanding Life Science Tools Presence. The deal would add Bio-Techne’s multiomics offerings, analytical technologies, and integrated workflow solutions to German Merck’s platforms and services in research, bioprocessing and advanced therapeutics, with the aim of creating a combined company capable of helping customers from discovery…
TL;DR: The post Merck KGaA to Acquire Bio-Techne for $11.3B, Expanding Life Science Tools Presence appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

BIO 2026: FDA Leadership Confront Workforce Losses, China Competition in Drug Development

The panel, which featured the acting directors of Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, and the acting chief of staff, focused on the FDA’s current priorities and initiatives. The post BIO 2026: FDA Leadership Confront Workforce Losses, China Competition in Drug Development appeared first on GEN - Genetic Engineering and Biotechnology News .

More: BIO 2026: FDA Leadership Confront Workforce Losses, China Competition in Drug Development. The panel, which featured the acting directors of Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research, and the acting chief of staff, focused on the FDA’s current priorities and initiatives.
TL;DR: The post BIO 2026: FDA Leadership Confront Workforce Losses, China Competition in Drug Development appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Recordati licenses Ionis drug; Vaxart's BARDA funding is cut

Plus news about Leyden Labs, Otsuka, Pfizer and Hutchmed. 🤝 Recordati licenses Ionis’ Alexander disease drug: The Italian company will be responsible for regulatory and commercial activities for Ionis’ candidate, known ...

More: Recordati licenses Ionis drug; Vaxart's BARDA funding is cut. Plus news about Leyden Labs, Otsuka, Pfizer and Hutchmed. 🤝 Recordati licenses Ionis’ Alexander disease drug: The Italian company will be responsible for regulatory and commercial activities for Ionis’ candidate, known ...
TL;DR: Plus news about Leyden Labs, Otsuka, Pfizer and Hutchmed.
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Retracted paper on timing of cancer therapy hands ammunition to anti-China lobby

Nature Medicine has retracted a high-profile paper it published in February detailing the results of a China-based trial suggesting that cancer immunotherapy was more effective if given to lung cancer patients ...

More: Na&shy;ture Med&shy;i&shy;cine has re&shy;tract&shy;ed a high-pro&shy;file pa&shy;per it pub&shy;lished in Feb&shy;ru&shy;ary de&shy;tail&shy;ing the re&shy;sults of a Chi&shy;na-based tri&shy;al sug&shy;gest&shy;ing that can&shy;cer … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Nature Medicine has retracted a high-profile paper it published in February detailing the results of a China-based trial suggesting that cancer immunotherapy was more effective if given to lung cancer patients ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Achieve Life Sciences gets a CRL; UPS invests $48M in healthcare logistics

Plus, news about AdvanCell and Jubilant. 🔴 FDA rejects drug for nicotine dependence: Achieve Life Sciences received a complete response letter for cytisinicline due to issues at a third-party manufacturing facility ...

More: Achieve Life Sciences gets a CRL; UPS invests $48M in healthcare logistics. Plus, news about AdvanCell and Jubilant. 🔴 FDA rejects drug for nicotine dependence: Achieve Life Sciences received a complete response letter for cytisinicline due to issues at a third-party manufacturing facility ...
TL;DR: Plus, news about AdvanCell and Jubilant.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Compounder Olympia Pharmaceuticals eyes peptide opportunity

An FDA committee will meet next month to discuss lifting a ban on a number of peptides marketed for wellness. Compounding pharmacies have been gearing up for the moment. One compounder, Olympia Pharmaceuticals, told me ...

More: Compounder Olympia Pharmaceuticals eyes peptide opportunity. Compounding pharmacies have been gearing up for the moment. One compounder, Olympia Pharmaceuticals, told me ...
TL;DR: An FDA committee will meet next month to discuss lifting a ban on a number of peptides marketed for wellness.
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Otsuka posts phase 3b ADHD trial win ahead of looming FDA approval decision

A phase 3b trial of Otsuka’s attention-deficit/hyperactivity disorder prospect has hit its primary endpoint, strengthening the drugmaker’s hand weeks before a potential U.S. launch of the therapy.

More: The study evaluated centanafadine in adults with ADHD and comorbid anxiety. Otsuka filled the evidence gap by enrolling 315 people with ADHD and comorbid anxiety in a phase 3b study. The earlier trials excluded people with anxiety that could confound results or require the use of prohibited drugs.
TL;DR: A phase 3b trial of Otsuka’s attention-deficit/hyperactivity disorder prospect has hit its primary endpoint, strengthening the drugmaker’s hand weeks before a potential U.S.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

BIO 2026: How a gut feeling transformed cancer treatment forever

Dr. Israel Lowy remembers the days when he and his oncology immunotherapy colleagues were assigned tables in the distant east wing of the American Society of Clinical Oncology conference in Chicago. They would watch aficionados walk by, scoffing at these iconoclastic researchers pushing an alternative way to treat cancer.

More: Israel Lowy remembers the days when he and his oncology immunotherapy colleagues were assigned tables in the distant east wing of the American Society of Clinical Oncology conference in Chicago. They would watch aficionados walk by, scoffing at these iconoclastic researchers pushing an alternative way to treat cancer.
TL;DR: Israel Lowy remembers the days when he and his oncology immunotherapy colleagues were assigned tables in the distant east wing of the American Society of Clinical Oncology conference in Chicago.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

With $15M discovery deal, Boehringer becomes latest Big Pharma to buy into Immunai’s AI platform

TechBio outfit Immunai is continuing its parade of Big Pharma partnerships with its third such pact this year, this time with German drugmaker Boehringer Ingelheim.

More: Boehringer is ponying up as much as $15 million to discover new targets on dysfunctional T cells that drive both cancers and autoimmune diseases, Immunai announced today. The team-up will start by harnessing Immunai’s single-cell AI platform to analyze T cells from patients with various cancers and autoimmune diseases, according to the release, in order to build a solid founda…
TL;DR: TechBio outfit Immunai is continuing its parade of Big Pharma partnerships with its third such pact this year, this time with German drugmaker Boehringer Ingelheim.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

InduPro Licenses Lonza’s Linker Payload Technologies and Bioconjugation Platforms

Lonza and InduPro signed the licensing agreement to develop differentiated therapeutic approaches designed to address complex diseases such as cancer, where precision targeting and efficacy remain critically important. The post InduPro Licenses Lonza’s Linker Payload Technologies and Bioconjugation Platforms appeared first on GEN - Genetic Engineering and Biotechnology News .

More: InduPro Licenses Lonza’s Linker Payload Technologies and Bioconjugation Platforms. Lonza and InduPro signed the licensing agreement to develop differentiated therapeutic approaches designed to address complex diseases such as cancer, where precision targeting and efficacy remain critically important.
TL;DR: The post InduPro Licenses Lonza’s Linker Payload Technologies and Bioconjugation Platforms appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

FDA drops blood pressure device enforcement against Whoop

The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the agency’s investigation into its blood pressure tech use.

More: Jun 25, 2026 8:20am Whoop FDA Devices MedTech The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the agency’s investigation into its blood pressure tech use.
TL;DR: The FDA has sent an End of Enforcement notice to consumer wearable device company Whoop, putting a formal end to the agency’s investigation into its blood pressure tech use.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Ionis bags $30M from Recordati for ex-US rights to near-approval rare disease prospect

Ionis Pharmaceuticals has offloaded regional rights to its near-approval rare disease asset zilganersen, pocketing $30 million upfront from Recordati for an ex-U.S. license to the drug candidate.

More: Ionis bags $30M from Recordati for ex-US rights to near-approval rare disease prospect. Ionis Pharmaceuticals has offloaded regional rights to its near-approval rare disease asset zilganersen, pocketing $30 million upfront from Recordati for an ex-U.S. license to the drug candidate.
TL;DR: license to the drug candidate.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Autoimmune disease company Oblenio Bio clinches $62M in Series B

Oblenio Bio has secured $62 million in a Series B raise led by Pfizer Ventures to advance a trispecific T-cell engager (TCE) for autoimmune diseases into a first-in-human study. The oversubscribed fundraise marks yet another ...

More: Oblenio Bio has secured $62 million in a Series B raise led by Pfizer Ventures to advance a trispecific T-cell engager (TCE) for autoimmune diseases into a first-in-human study. The oversubscribed fundraise marks yet another ...
TL;DR: Oblenio Bio has secured $62 million in a Series B raise led by Pfizer Ventures to advance a trispecific T-cell engager (TCE) for autoimmune diseases into a first-in-human study.
Read original at Endpoints
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Bipartisan bill seeks to allow direct prescribing of methadone for opioid addiction

Methadone for opioid addiction has been available only at specialty clinics. A bipartisan bill would greatly expand access.

More: Bipartisan bill seeks to allow direct prescribing of methadone for opioid addiction. Methadone for opioid addiction has been available only at specialty clinics. A bipartisan bill would greatly expand access.
TL;DR: Methadone for opioid addiction has been available only at specialty clinics.
Read original at Statnews
Further reading: Genome.govBioRxivGenetic Engineering BasicsWikipedia

Drug Targets LDL Receptor Pathway to Control Cholesterol

Researchers uncovered a biological pathway that explains why high-cholesterol diets reduce the body's ability to clear harmful LDL cholesterol from the blood and identified a clinical-stage drug candidate that could potentially target the pathway. The post Drug Targets LDL Receptor Pathway to Control Cholesterol appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Drug Targets LDL Receptor Pathway to Control Cholesterol. Researchers uncovered a biological pathway that explains why high-cholesterol diets reduce the body's ability to clear harmful LDL cholesterol from the blood and identified a clinical-stage drug candidate that could potentially target the pathway.
TL;DR: The post Drug Targets LDL Receptor Pathway to Control Cholesterol appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Spurned by FDA, Passage Bio finds exit through merger with Remix

Passage Bio, the Philadelphia-based gene therapy outfit that launched a strategic review earlier this year after tough feedback from the FDA, has found an exit in an all-stock reverse merger with RNA specialist Remix Therapeutics.

More: Should the merger go through, Passage Bio shareholders will own 7% of the combined company, which will keep the Remix name. Passage launched a strategic review in May after the FDA disapproved of the biotech’s plan for a single-arm trial of its gene therapy candidate for frontotemporal dementia, PBFT02.
TL;DR: Passage Bio, the Philadelphia-based gene therapy outfit that launched a strategic review earlier this year after tough feedback from the FDA, has found an exit in an all-stock reverse merger with RNA specialist Remix Therapeutics.
Read original at Fiercebiotech
Further reading: PubMedBioRxivGenetic Engineering BasicsWikipedia

Ionis wins FDA label expansion to reduce triglycerides, pancreatitis

Ionis landed an FDA approval on Wednesday that will greatly expand its commercial opportunity for Tryngolza. The antisense drug may now be used to treat patients who have severely high levels of fat molecules called ...

More: Ionis wins FDA label expansion to reduce triglycerides, pancreatitis. Ionis landed an FDA approval on Wednesday that will greatly expand its commercial opportunity for Tryngolza. The antisense drug may now be used to treat patients who have severely high levels of fat molecules called ...
TL;DR: Ionis landed an FDA approval on Wednesday that will greatly expand its commercial opportunity for Tryngolza.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

FDA backs Gilead’s Trodelvy for first-line, triple-negative breast cancer

One month after Daiichi Sankyo and AstraZeneca’s drug Datroway received a key breast cancer approval from the FDA, the agency has granted Gilead two approvals for its competing therapy Trodelvy. The FDA's Wednesday

More: One month af&shy;ter Dai&shy;ichi Sankyo and As&shy;traZeneca’s drug Da&shy;troway re&shy;ceived a key breast can&shy;cer ap&shy;proval from the FDA, the agency has grant&shy;ed Gilead two ap&shy;provals … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: One month after Daiichi Sankyo and AstraZeneca’s drug Datroway received a key breast cancer approval from the FDA, the agency has granted Gilead two approvals for its competing therapy Trodelvy.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Remix does reverse merger with Passage Bio for mRNA degrader

A nimble biotech working on small molecule mRNA degraders will take the Nasdaq listing of a once-promising gene therapy biotech co-founded by Jim Wilson. Remix Therapeutics plans to take over Passage Bio's ...

More: Remix does reverse merger with Passage Bio for mRNA degrader. A nimble biotech working on small molecule mRNA degraders will take the Nasdaq listing of a once-promising gene therapy biotech co-founded by Jim Wilson. Remix Therapeutics plans to take over Passage Bio's ...
TL;DR: A nimble biotech working on small molecule mRNA degraders will take the Nasdaq listing of a once-promising gene therapy biotech co-founded by Jim Wilson.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

First-in-Human Stem Cell Therapy Trial for Huntington’s Disease Begins at UCI Health

UCI Health has launched the world’s first human clinical trial using embryonic stem cell-derived neural cells for Huntington’s disease, testing MRI-guided surgical brain delivery to evaluate safety and early therapeutic potential. The post First-in-Human Stem Cell Therapy Trial for Huntington’s Disease Begins at UCI Health appeared first on GEN - Genetic Engineering and Biotechnology News .

More: First-in-Human Stem Cell Therapy Trial for Huntington’s Disease Begins at UCI Health. UCI Health has launched the world’s first human clinical trial using embryonic stem cell-derived neural cells for Huntington’s disease, testing MRI-guided surgical brain delivery to evaluate safety and early therapeutic potential.
TL;DR: The post First-in-Human Stem Cell Therapy Trial for Huntington’s Disease Begins at UCI Health appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

BIO 2026: CEO Calls for U.S. Biotech Urgency and International Competitiveness

John Crowley emphasized industry modernization and solving "man-made problems" to outcompete rivals like China through improved U.S. innovation ecosystems. The post BIO 2026: CEO Calls for U.S. Biotech Urgency and International Competitiveness appeared first on GEN - Genetic Engineering and Biotechnology News .

More: BIO 2026: CEO Calls for U.S. The post BIO 2026: CEO Calls for U.S. Biotech Urgency and International Competitiveness appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: Biotech Urgency and International Competitiveness appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Acting FDA leaders look to rebuild staff, industry trust after tumult

After a year of disruptions and industry consternation, a trio of current FDA leaders tried to turn over a new leaf both in the agency’s relationship with the industry it regulates and the staff that ...

More: Af&shy;ter a year of dis&shy;rup&shy;tions and in&shy;dus&shy;try con&shy;ster&shy;na&shy;tion, a trio of cur&shy;rent FDA lead&shy;ers tried to turn over a new leaf both in the agency’s … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: After a year of disruptions and industry consternation, a trio of current FDA leaders tried to turn over a new leaf both in the agency’s relationship with the industry it regulates and the staff that ...
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Icon names Microsoft tech partner as Q1 results grow analyst confidence

Irish CRO giant Icon this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years. Microsoft’s Copilot and data infrastructure will be implemented enterprise-wide to further scale Icon’s agentic AI platform, Orbis.

More: Icon names Microsoft tech partner as Q1 results grow analyst confidence. Irish CRO giant Icon this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years. Microsoft’s Copilot and data infrastructure will be implemented enterprise-wide to further scale Icon’s agentic AI platform, Orbis.
TL;DR: Irish CRO giant Icon this week made Microsoft its technology partner as the organization advances its plan to increase investment in AI over the next three years.
Read original at Fiercebiotech
Further reading: Genome.govNature BiotechBioTech PrimerWikipedia

Former employee sues and claims BioNTech cut corners in pancreatic cancer trials

A former senior clinical trial manager at BioNTech sued the German company in North Carolina district court on Monday, alleging protocol deviations and other safety concerns in two ongoing pancreatic cancer trials. The employee, a ...

More: A for&shy;mer se&shy;nior clin&shy;i&shy;cal tri&shy;al man&shy;ag&shy;er at BioN&shy;Tech sued the Ger&shy;man com&shy;pa&shy;ny in North Car&shy;oli&shy;na dis&shy;trict court on Mon&shy;day, al&shy;leg&shy;ing pro&shy;to&shy;col de&shy;vi&shy;a&shy;tions and oth&shy;er safe&shy;ty … Get free access to a limited number of articles, plus choose newsletters to get straight to…
TL;DR: A former senior clinical trial manager at BioNTech sued the German company in North Carolina district court on Monday, alleging protocol deviations and other safety concerns in two ongoing pancreatic cancer trials.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Mapp, Gilead antivirals to be deployed in DRC Ebola trial: WHO chief

Officials are planning to study Mapp Biopharmaceutical’s MBP134 and Gilead Sciences’ remdesivir, which gained prominence during the COVID-19 pandemic, against the Bundibugyo ebolavirus.

More: Jun 24, 2026 3:03pm Tedros Adhanom Ghebreyesus World Health Organization Ebola Gilead Sciences As health officials grapple with a fast-moving outbreak of the Bundibugyo ebolavirus in the Democratic Republic of Congo, the World Health Organization today revealed plans to kick off a trial of two potential therapeutics—either alone or in combination with one another.
TL;DR: Officials are planning to study Mapp Biopharmaceutical’s MBP134 and Gilead Sciences’ remdesivir, which gained prominence during the COVID-19 pandemic, against the Bundibugyo ebolavirus.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Novel Feeder Cell Line Dramatically Expands NK Cell Production

A new feeder cell line multiplies NK cells by more than 100,000-fold in one month, making it easier to produce these therapeutic cells at commercial quantities and thus develop off-the-shelf cancer immunotherapies. The post Novel Feeder Cell Line Dramatically Expands NK Cell Production appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Novel Feeder Cell Line Dramatically Expands NK Cell Production. A new feeder cell line multiplies NK cells by more than 100,000-fold in one month, making it easier to produce these therapeutic cells at commercial quantities and thus develop off-the-shelf cancer immunotherapies.
TL;DR: The post Novel Feeder Cell Line Dramatically Expands NK Cell Production appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Recoded E. coli Promises More Scalable Weight Loss Drug Production

Manufacturing weight loss drugs at high volume at lower cost with less wastage could get easier thanks to a recoded E.coli strain that can produce long peptide chains containing non-natural chemistries. The post Recoded <i>E. coli</i> Promises More Scalable Weight Loss Drug Production appeared first on GEN - Genetic Engineering and Biotechnology News .

More: coli Promises More Scalable Weight Loss Drug Production. Manufacturing weight loss drugs at high volume at lower cost with less wastage could get easier thanks to a recoded E.coli strain that can produce long peptide chains containing non-natural chemistries.
TL;DR: coli</i> Promises More Scalable Weight Loss Drug Production appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Scaling Stem-Cell Manufacturing for Therapies

As more than 100 clinical trials test human pluripotent stem cell-derived therapies, researchers are shifting focus from proving large-scale production is possible to building standardized, AI-enabled manufacturing systems capable of delivering consistent, clinically compliant cell products. The post Scaling Stem-Cell Manufacturing for Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Scaling Stem-Cell Manufacturing for Therapies. As more than 100 clinical trials test human pluripotent stem cell-derived therapies, researchers are shifting focus from proving large-scale production is possible to building standardized, AI-enabled manufacturing systems capable of delivering consistent, clinically compliant cell products.
TL;DR: The post Scaling Stem-Cell Manufacturing for Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

WHO Selects NIBRT as Training Hub to Help LMICs Build Biopharma Capacity

The WHO has selected Ireland’s NIBRT as its European hub for engineering education. The aim is to give production staff skills in automation, AI, and other advanced techniques so they can build local manufacturing capacity. The post WHO Selects NIBRT as Training Hub to Help LMICs Build Biopharma Capacity appeared first on GEN - Genetic Engineering and Biotechnology News .

More: The WHO has selected Ireland’s NIBRT as its European hub for engineering education. The aim is to give production staff skills in automation, AI, and other advanced techniques so they can build local manufacturing capacity. The post WHO Selects NIBRT as Training Hub to Help LMICs Build Biopharma Capacity appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post WHO Selects NIBRT as Training Hub to Help LMICs Build Biopharma Capacity appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Whoop dodges FDA enforcement action

The FDA said it will not take enforcement action against Whoop, nearly a year after it warned the wearable maker over its blood pressure tracker. The agency last July accused Whoop of ...

More: The FDA said it will not take enforcement action against Whoop, nearly a year after it warned the wearable maker over its blood pressure tracker. The agency last July accused Whoop of ...
TL;DR: The FDA said it will not take enforcement action against Whoop, nearly a year after it warned the wearable maker over its blood pressure tracker.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Novartis taps Antares in small molecule discovery pact with $105M upfront

Antares Therapeutics will be collaborating with Novartis to find unique small molecule candidates for multiple “undruggable” cancer targets, with the biotech receiving $105 million upfront. “We're discovering and developing with Novartis targets that have never ...

More: Novartis taps Antares in small molecule discovery pact with $105M upfront. Antares Therapeutics will be collaborating with Novartis to find unique small molecule candidates for multiple “undruggable” cancer targets, with the biotech receiving $105 million upfront. “We're discovering and developing with Novartis targets that have never ...
TL;DR: Antares Therapeutics will be collaborating with Novartis to find unique small molecule candidates for multiple “undruggable” cancer targets, with the biotech receiving $105 million upfront.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Verastem's KRAS G12D vision; ADC Therapeutics reorganizes, lays off 17% of staff

📊 Verastem’s KRAS G12D plans: Verastem’s Tuesday release on its KRAS G12D drug didn’t include much efficacy data — the company said that key update is coming later this year. But, the ...

More: 📊 Ve&shy;rastem’s KRAS G12D plans: Ve&shy;rastem’s Tues&shy;day re&shy;lease on its KRAS G12D drug didn’t in&shy;clude much ef&shy;fi&shy;ca&shy;cy da&shy;ta — the com&shy;pa&shy;ny said … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: 📊 Verastem’s KRAS G12D plans: Verastem’s Tuesday release on its KRAS G12D drug didn’t include much efficacy data — the company said that key update is coming later this year.
Read original at Endpoints
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Nature retracts provocative PD-1 study that tied lung cancer survival to treatment timing

After a four-month investigation, Nature Medicine has decided to pull a viral study that linked early-day PD-1/chemo treatment to a massive survival benefit versus late-day infusion in non-small cell lung cancer.

More: Jun 24, 2026 11:00am study retraction PD-1 immuno-oncology immunotherapy A Nature Medicine paper landed on Feb. By midday, renowned physician-scientist Eric Topol, M.D., had signaled its importance to his more than 700K followers on X, then hailing it as “probably the best proof of the importance of timing of therapy that we’ve seen in medicine to date.
TL;DR: After a four-month investigation, Nature Medicine has decided to pull a viral study that linked early-day PD-1/chemo treatment to a massive survival benefit versus late-day infusion in non-small cell lung cancer.
Read original at Fiercebiotech
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

Endpoints H1 2026 CEO survey: Fallout from MFN and suggestions for the FDA

This time a year ago, biotech execs were in the worst mood we’ve seen in the eight years we’ve been surveying them. IPOs were on the skids, the FDA was in turmoil and the Chinese ...

More: Endpoints H1 2026 CEO survey: Fallout from MFN and suggestions for the FDA. This time a year ago, biotech execs were in the worst mood we’ve seen in the eight years we’ve been surveying them. IPOs were on the skids, the FDA was in turmoil and the Chinese ...
TL;DR: This time a year ago, biotech execs were in the worst mood we’ve seen in the eight years we’ve been surveying them.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Medra Launches Reasoning Layer for Drug Discovery Robotics

The physical AI system, named AI Experimentalist, translates research goals from natural language into executable workflows that span the entire experimental cycle, from literature review, wet-lab execution, data analysis, and protocol refinement. The post Medra Launches Reasoning Layer for Drug Discovery Robotics appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Medra Launches Reasoning Layer for Drug Discovery Robotics. The physical AI system, named AI Experimentalist, translates research goals from natural language into executable workflows that span the entire experimental cycle, from literature review, wet-lab execution, data analysis, and protocol refinement.
TL;DR: The post Medra Launches Reasoning Layer for Drug Discovery Robotics appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Spotlight on RNA Therapeutics

Credit: Christoph Burgstedt / Science Photo Library / Getty Images Drew Weissman, MD, PhD Professor in Vaccine Research Penn Medicine View Bio Panelist Drew Weissman, MD, PhD Drew Weissman, MD, PhD,…

More: Spotlight on RNA Therapeutics. The COVID-19 RNA vaccine received FDA approval in August 2021. Weissman’s lab is currently working on a pan-coronavirus vaccine, a universal flu vaccine, and a vaccine to prevent herpes.
TL;DR: They are working with Penn colleagues to develop cancer therapeutics with mRNA technology.
Read original at Genengnews
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Novartis pays Antares $105M to illuminate undruggable cancer targets

Novartis is paying Antares Therapeutics $105 million upfront in a deal worth up to $1.9 billion to generate small molecules against historically undruggable oncology targets.

More: Antares spun out of Scorpion Therapeutics in 2025 after Eli Lilly bought the biotech’s PI3Kα pipeline for up to $2.5 billion. Novartis is harnessing Antares’ covalent drug discovery engine to go after “a limited number” of targets. Novartis has options on the programs.
TL;DR: Novartis is paying Antares Therapeutics $105 million upfront in a deal worth up to $1.9 billion to generate small molecules against historically undruggable oncology targets.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

RQ Bio reels in $115M to take long-acting flu prevention antiviral into clinic

Amid a bustling fundraising week for biotechs, the U.K.’s RQ Bio is adding $115 million to its coffers to advance a long-acting antibody for flu prevention.

More: Jun 24, 2026 9:43am Influenza RQ Bio Frazier Life Sciences Amid a bustling fundraising week for biotechs, the U.K.’s RQ Bio is adding $115 million to its coffers to advance a long-acting antibody for flu prevention.  RQ Bio’s series A raise, unveiled on Wednesday, will help the company propel its lead program, RQB01, into clinical testing next year.
TL;DR: Amid a bustling fundraising week for biotechs, the U.K.’s RQ Bio is adding $115 million to its coffers to advance a long-acting antibody for flu prevention.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Access Vascular taps Medline to help roll out new line of catheters

Access Vascular, a Massachusetts-based device maker that focuses on intravenous catheters, inked a partnership deal with medical supply giant Medline to help roll out a new line of catheters.

More: Although financial details of the deal weren’t disclosed, the partnership is focused on the distribution of Access Vascular’s line of HydroMID and HydroPICC catheters that recently garnered an anti-thrombogenic indication from the FDA, the company said in a June 23 press release.
TL;DR: Access Vascular, a Massachusetts-based device maker that focuses on intravenous catheters, inked a partnership deal with medical supply giant Medline to help roll out a new line of catheters.
Read original at Fiercebiotech
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Insulet hires Convatec, Eli Lilly alum as new R&D chief

Jun 24, 2026 7:57am Insulet Eli Lilly Diabetes insulin Omnipod maker Insulet has hired Divakar Ramakrishnan, Ph.D., as its new Chief Research and Development Officer.

More: Jun 24, 2026 7:57am Insulet Eli Lilly Diabetes insulin Omnipod maker Insulet has hired Divakar Ramakrishnan, Ph.D., as its new Chief Research and Development Officer. Previously, he also served six years at Eli Lilly and before that a one-year stint at Moderna.
TL;DR: Omnipod maker Insulet has hired Divakar Ramakrishnan, Ph.D., as its new Chief Research and Development Officer.
Read original at Fiercebiotech
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Eli Lilly reunites with Abbisko in $1.9B, multiple target R&D pact

Eli Lilly has expanded its relationship with Abbisko Therapeutics, committing up to $1.9 billion to get the Chinese biotech to apply its drug discovery and early development capabilities to multiple targets.

More: Abbisko  partnered with Lilly in 2022 to collaborate on a small molecule drug candidate. While Abbisko mainly focuses on cancer, the biotech  describes (PDF) the P151 drug candidate co-owned with Lilly as a cardiometabolic program. Assigning those tasks to the Shanghai-based biotech positions Lilly to benefit from the fast pace of early development in China.
TL;DR: Eli Lilly has expanded its relationship with Abbisko Therapeutics, committing up to $1.9 billion to get the Chinese biotech to apply its drug discovery and early development capabilities to multiple targets.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Ollin nets $330M to run Phase 3 trials of Vabysmo challenger from China

Ollin Biosciences announced a $330 million Series B to fund pivotal studies around what it hopes can be a more potent competitor to Genentech’s eye drug Vabysmo. The large funding round comes after the biotech ...

More: Ollin nets $330M to run Phase 3 trials of Vabysmo challenger from China. Ollin Biosciences announced a $330 million Series B to fund pivotal studies around what it hopes can be a more potent competitor to Genentech’s eye drug Vabysmo. The large funding round comes after the biotech ...
TL;DR: Ollin Biosciences announced a $330 million Series B to fund pivotal studies around what it hopes can be a more potent competitor to Genentech’s eye drug Vabysmo.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

California Still Golden Despite Job Losses: Industry Group

BIOCOM California quantified the economic impact of the Golden State’s life sciences industry as generating $394 billion in economic output in 2025—a figure that goes beyond the direct impact of the 406,505 people employed by life sciences employers across the state. However, all three of the state’s top-tier life-sci clusters—the San Francisco Bay Area, San Diego, and the Los Angeles/Orange County region—saw decreases in employment within the industry last year. The post California Still Golden Despite Job Losses: Industry Group appeared first on GEN - Genetic Engineering and Biotechnology News .

More: BIOCOM California quantified the economic impact of the Golden State’s life sciences industry as generating $394 billion in economic output in 2025—a figure that goes beyond the direct impact of the 406,505 people employed by life sciences employers across the state.
TL;DR: The post California Still Golden Despite Job Losses: Industry Group appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

Lilly offers up to $1.9B in new drug discovery deal with Abbisko

Building on a pact from 2022, Eli Lilly has signed a new discovery collaboration with Abbisko Therapeutics that could see it pay the Chinese biotech up to $1.9 billion. Abbisko said ...

More: Build&shy;ing on a pact from 2022, Eli Lil&shy;ly has signed a new dis&shy;cov&shy;ery col&shy;lab&shy;o&shy;ra&shy;tion with Ab&shy;bisko Ther&shy;a&shy;peu&shy;tics that could see it pay the Chi&shy;nese biotech … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Building on a pact from 2022, Eli Lilly has signed a new discovery collaboration with Abbisko Therapeutics that could see it pay the Chinese biotech up to $1.9 billion.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Ollin hauls in $330M to enlist Vabysmo challenger in phase 3 eye disease gauntlet

Half a year after toppling Genentech’s eye medicine giant Vabysmo in an early trial, Texas biotech Ollin Biosciences has lassoed a $330 million series B to push its winning contender through a multi-trial phase 3 gauntlet.

More: With designs on launching its VEGF/Ang2 bispecific antibody OLN324 into at least three phase 3 trials, Ollin needed substantial backing, co-founder and CEO Jason Ehrlich told Fierce Biotech.  Two trials will focus on the lead indication of diabetic macular edema, where OLN324 topped Vabysmo in an earlier phase 1b trial, while at least one other will focus on wet age-related ma…
TL;DR: Half a year after toppling Genentech’s eye medicine giant Vabysmo in an early trial, Texas biotech Ollin Biosciences has lassoed a $330 million series B to push its winning contender through a multi-trial phase 3 gauntlet.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Opinion: New human embryo editing advances require tough conversations on ethical boundaries

Scientists can’t ignore the ethical complexities of new embryo editing advances.

More: Opinion: New human embryo editing advances require tough conversations on ethical boundaries. Scientists can’t ignore the ethical complexities of new embryo editing advances.
TL;DR: Scientists can’t ignore the ethical complexities of new embryo editing advances.
Read original at Statnews
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Gene Editing Pioneer Sangamo Files for Chapter 11 Bankruptcy; Agrees to Sell Assets

Eli Lilly has agreed to acquire Sangamo’s capsid delivery platform, zinc finger nuclease (ZFN) platform, modular integrase (MINT) platform, and prion disease program, ST-506. Astellas Pharma has agreed to take over Sangamo’s Fabry disease program, isaralgagene civaparvovec (ST-920). To clinch the deals, Lilly and Astellas have agreed to be “stalking horse” bidders when Sangamo’s assets are sold in a future bankruptcy court auction. The post Gene Editing Pioneer Sangamo Files for Chapter 11 Bankruptcy; Agrees to Sell Assets appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Gene Editing Pioneer Sangamo Files for Chapter 11 Bankruptcy; Agrees to Sell Assets. Eli Lilly has agreed to acquire Sangamo’s capsid delivery platform, zinc finger nuclease (ZFN) platform, modular integrase (MINT) platform, and prion disease program, ST-506. Astellas Pharma has agreed to take over Sangamo’s Fabry disease program, isaralgagene civaparvovec (ST-920).
TL;DR: The post Gene Editing Pioneer Sangamo Files for Chapter 11 Bankruptcy; Agrees to Sell Assets appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Osanni Bio gets $190M to build ophthalmology and cardiology pipeline

A San Francisco biotech looking to build out a suite of ophthalmology- and cardiology-focused "affiliate companies" has raised $190 million. Osanni Bio disclosed the Series B on Tuesday, mainly with backing ...

More: Osanni Bio gets $190M to build ophthalmology and cardiology pipeline. A San Francisco biotech looking to build out a suite of ophthalmology- and cardiology-focused "affiliate companies" has raised $190 million. Osanni Bio disclosed the Series B on Tuesday, mainly with backing ...
TL;DR: A San Francisco biotech looking to build out a suite of ophthalmology- and cardiology-focused "affiliate companies" has raised $190 million.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Three Subtypes of Severe Pneumonia Might Inform Personalized Therapies

An analysis of human lung fluid samples from hospitalized patients identified three different subtypes of severe pneumonia, a finding which the researchers say could help to explain different outcomes, and potentially inform personalized therapeutics. The post Three Subtypes of Severe Pneumonia Might Inform Personalized Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Three Subtypes of Severe Pneumonia Might Inform Personalized Therapies. An analysis of human lung fluid samples from hospitalized patients identified three different subtypes of severe pneumonia, a finding which the researchers say could help to explain different outcomes, and potentially inform personalized therapeutics.
TL;DR: The post Three Subtypes of Severe Pneumonia Might Inform Personalized Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Nvidia Unveils Science Reasoning AI Suite with BioNeMo Agent Toolkit

The toolkit turns complex scientific workflows into agent-executable tasks and has applications across protein structure prediction, molecular docking, generative chemistry, genomic analysis, protein design, and biomarker discovery.   The post Nvidia Unveils Science Reasoning AI Suite with BioNeMo Agent Toolkit appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Nvidia Unveils Science Reasoning AI Suite with BioNeMo Agent Toolkit. The toolkit turns complex scientific workflows into agent-executable tasks and has applications across protein structure prediction, molecular docking, generative chemistry, genomic analysis, protein design, and biomarker discovery.
TL;DR:   The post Nvidia Unveils Science Reasoning AI Suite with BioNeMo Agent Toolkit appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Nextgen Platform Combines VectorBuilder and Maxcyte Technologies to Boost Clinical-Grade Cell Engineering

The aim of the partnership is to provide a platform delivering high-end performance with an optimal cost-of-goods and price-per-dose model to ease scale-up, commercial strategy, and fundraising efforts for drug developers. The post Nextgen Platform Combines VectorBuilder and Maxcyte Technologies to Boost Clinical-Grade Cell Engineering appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Nextgen Platform Combines VectorBuilder and Maxcyte Technologies to Boost Clinical-Grade Cell Engineering. The aim of the partnership is to provide a platform delivering high-end performance with an optimal cost-of-goods and price-per-dose model to ease scale-up, commercial strategy, and fundraising efforts for drug developers.
TL;DR: The post Nextgen Platform Combines VectorBuilder and Maxcyte Technologies to Boost Clinical-Grade Cell Engineering appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Discreet biotech Osanni Bio starts making noise with $190M series B for clinical push

An under-the-radar Bay Area biotech has brought in a $190 million series B with the goal of hatching a clutch of new companies to fly its drug candidates forward.

More: Jun 23, 2026 2:28pm Fundraising biotech venture capital age-related macular degeneration bioengineering An under-the-radar Bay Area biotech has brought in a $190 million series B with the goal of hatching a clutch of new companies to fly its drug candidates forward.
TL;DR: An under-the-radar Bay Area biotech has brought in a $190 million series B with the goal of hatching a clutch of new companies to fly its drug candidates forward.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Serapha Bio takes flight from Boundless merger with $230M and gene-editing prospect from China

The focus of the company is SERP-01, an in vivo base editing program targeting AATD developed in China and licensed from YolTech Therapeutics.

More: Jun 23, 2026 1:55pm Boundless Bio Cell & Gene Therapy base editing reverse merger When writing a blockbuster movie script, screenplay writers are sure to include all the essential elements of a hit film. In the biotech world, the launch of Serapha Bio seems to follow this formula, touching on many of the big themes present in the industry today.
TL;DR: The focus of the company is SERP-01, an in vivo base editing program targeting AATD developed in China and licensed from YolTech Therapeutics.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Sangamo’s three-decade run comes to a close as Lilly and Astellas eye assets

Despite being an early player in the gene editing field and developing numerous clinical programs, Sangamo Therapeutics will be selling off its parts without materializing any approved therapies. Sangamo

More: De&shy;spite be&shy;ing an ear&shy;ly play&shy;er in the gene edit&shy;ing field and de&shy;vel&shy;op&shy;ing nu&shy;mer&shy;ous clin&shy;i&shy;cal pro&shy;grams, Sang&shy;amo Ther&shy;a&shy;peu&shy;tics will be sell&shy;ing off … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Despite being an early player in the gene editing field and developing numerous clinical programs, Sangamo Therapeutics will be selling off its parts without materializing any approved therapies.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

A different kind of AI entrant in healthcare

For as long as I’ve been reporting, I’ve been tracking tech companies’ fascination with healthcare. There are good reasons for it. Patients aren’t having great experiences, the market is only ...

More: A different kind of AI entrant in healthcare. For as long as I’ve been reporting, I’ve been tracking tech companies’ fascination with healthcare. Patients aren’t having great experiences, the market is only ...
TL;DR: For as long as I’ve been reporting, I’ve been tracking tech companies’ fascination with healthcare.
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Boundless Bio reverse merger; CARsgen wins first solid tumor approval for CAR-T

Plus news about Definium Therapeutics, uniQure, MoonLake Immunotherapeutics, Versant Ventures, Corxel Pharmaceuticals and US WorldMeds. 🇨🇳 BOLD gives up: Boundless Bio {$BOLD}, which faced clinical setbacks over the years ...

More: Boundless Bio reverse merger; CARsgen wins first solid tumor approval for CAR-T. Plus news about Definium Therapeutics, uniQure, MoonLake Immunotherapeutics, Versant Ventures, Corxel Pharmaceuticals and US WorldMeds. 🇨🇳 BOLD gives up: Boundless Bio {$BOLD}, which faced clinical setbacks over the years ...
TL;DR: Plus news about Definium Therapeutics, uniQure, MoonLake Immunotherapeutics, Versant Ventures, Corxel Pharmaceuticals and US WorldMeds.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Pfizer late-stage ADC lung cancer fail calls cancer strategy into question

The failure of a Pfizer antibody-drug conjugate in its important late-stage lung cancer test is exactly what the New York drugmaker didn’t need. The asset, sigvotatug vedotin, was one of several ADCs Pfizer scooped up ...

More: Pfizer late-stage ADC lung cancer fail calls cancer strategy into question. The failure of a Pfizer antibody-drug conjugate in its important late-stage lung cancer test is exactly what the New York drugmaker didn’t need. The asset, sigvotatug vedotin, was one of several ADCs Pfizer scooped up ...
TL;DR: The failure of a Pfizer antibody-drug conjugate in its important late-stage lung cancer test is exactly what the New York drugmaker didn’t need.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Sangamo to put ‘substantially all’ assets for sale in bankruptcy, lines up Lilly and Astellas as buyers

Eli Lilly and Astellas have emerged as “stalking horse bidders” for certain assets as part of Sangamo’s bankruptcy process.

More: Jun 23, 2026 10:57am Sangamo Therapeutics Eli Lilly Astellas The beleaguered genomic medicine biotech Sangamo has traveled a rough road lately, with recent years featuring dashed R&D dreams and a precipitous stock price collapse. As of last June, Sangamo  touted data from a phase 1/2 trial that it said would support an effort to secure an accelerated approval.
TL;DR: Eli Lilly and Astellas have emerged as “stalking horse bidders” for certain assets as part of Sangamo’s bankruptcy process.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Merck KGaA pledges $50M to build new cardio biotech with eye to later acquisition

Merck KGaA has committed $50 million to build a new biotech with prolific life science investor Versant Ventures, with the ultimate goal of devouring the NewCo down the line.

More: The new outfit is called Saturnus Bio, Merck KGaA announced today, and will focus on developing medicines for rare genetic heart diseases. The German drugmaker’s cash will support Saturnus’ research work and grant Merck KGaA a minority stake in the company.
TL;DR: Merck KGaA has committed $50 million to build a new biotech with prolific life science investor Versant Ventures, with the ultimate goal of devouring the NewCo down the line.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Oura inks partnership with Eli Lilly's prescription platform

Wearable company Oura is partnering with LillyDirect, Eli Lilly’s direct-to-consumer telehealth platform, in hopes of helping patients on GLP-1 weight loss medications track changes in their health. LillyDirect customers on GLP-1 medication can receive a ...

More: Wear&shy;able com&shy;pa&shy;ny Oura is part&shy;ner&shy;ing with Lil&shy;ly&shy;Di&shy;rect, Eli Lil&shy;ly’s di&shy;rect-to-con&shy;sumer tele&shy;health plat&shy;form, in hopes of help&shy;ing pa&shy;tients on GLP-1 weight loss med&shy;ica&shy;tions track changes in … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Wearable company Oura is partnering with LillyDirect, Eli Lilly’s direct-to-consumer telehealth platform, in hopes of helping patients on GLP-1 weight loss medications track changes in their health.
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Big obesity bets and China's rise fuel potential $2T in 2032 drug sales: Evaluate

While dealmaking and investment dollars may be flowing across biopharma once again, acute challenges tied to policy, pricing and more continue to dog the industry, even as pipelines bring massive sales opportunities to bear.

More: Jun 23, 2026 9:00am biopharma industry U.S. It will be a time of heavy hitters, according to Evaluate, which predicts that five drugs will each reap sales beyond $20 billion that year, with the top 20 best-selling medications of 2032 tipped to collectively account for nearly a fifth of total revenues.  In essence, the “big drugs era continues,” Evaluate said of its forecast.
TL;DR: While dealmaking and investment dollars may be flowing across biopharma once again, acute challenges tied to policy, pricing and more continue to dog the industry, even as pipelines bring massive sales opportunities to bear.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Cytomos’ AuraCyt Digital Predictive Cell Analytics Platform Showcased at BIO Conference

Cytomos says its benchtop cell analytics intelligence system combines the compact Celledonia analyzer with the sensors of the AuraCyt modules to transform complex cellular data into actionable insights. The post Cytomos’ AuraCyt Digital Predictive Cell Analytics Platform Showcased at BIO Conference appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Cytomos’ AuraCyt Digital Predictive Cell Analytics Platform Showcased at BIO Conference. Cytomos says its benchtop cell analytics intelligence system combines the compact Celledonia analyzer with the sensors of the AuraCyt modules to transform complex cellular data into actionable insights.
TL;DR: The post Cytomos’ AuraCyt Digital Predictive Cell Analytics Platform Showcased at BIO Conference appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

FDA issues early alert for J&J’s Abiomed catheter introducer over bleeding risk

The FDA has sent out an early alert to J&J’s Abiomed unit and its manufacturing partner Oscor for their catheter introducer kits that are used with Impella heart pumps amid manufacturing concerns.

More: These concerns center on potential sheath leakage from the device, which is used to establish catheters into the body. It is part the company’s Impella heart pump kit.  “The unexpected leakage in these locations is due to certain manufacturing issues that increase the risk of access-site bleeding,” the FDA said in its alert .
TL;DR: The FDA has sent out an early alert to J&J’s Abiomed unit and its manufacturing partner Oscor for their catheter introducer kits that are used with Impella heart pumps amid manufacturing concerns.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Exelixis' zanzalintinib falls short in colorectal cancer subgroup

Despite the success of Exelixis’ oral tyrosine kinase inhibitor in a broader population, the candidate failed to significantly improve survival in colorectal cancer patients without liver metastases. The drugmaker said Monday ...

More: De&shy;spite the suc&shy;cess of Ex&shy;elix&shy;is’ oral ty&shy;ro&shy;sine ki&shy;nase in&shy;hibitor in a broad&shy;er pop&shy;u&shy;la&shy;tion, the can&shy;di&shy;date failed to sig&shy;nif&shy;i&shy;cant&shy;ly im&shy;prove sur&shy;vival in col&shy;orec&shy;tal can&shy;cer pa&shy;tients with&shy;out … Get free access to a limited number of articles, plus choose newslette…
TL;DR: Despite the success of Exelixis’ oral tyrosine kinase inhibitor in a broader population, the candidate failed to significantly improve survival in colorectal cancer patients without liver metastases.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Pfizer’s first new ADC from Seagen acquisition fails phase 3 NSCLC trial

Pfizer announced Monday that sigvotatug vedotin, the first new ADC to read out pivotal data following its $43 billion acquisition of Seagen, has stumbled in a phase 3 study in non-small cell lung cancer.

More: Jun 23, 2026 7:15am Pfizer antibody-drug conjugates non-small cell lung cancer Seagen Pfizer’s high-stakes bet on antibody-drug conjugates (ADCs) has hit a speed bump. The potential first-in-class ADC failed to significantly improve overall survival (OS) compared with the chemotherapy docetaxel in patients with previously treated nonsquamous NSCLC, causing the phase 3 SigVie-0…
TL;DR: Pfizer announced Monday that sigvotatug vedotin, the first new ADC to read out pivotal data following its $43 billion acquisition of Seagen, has stumbled in a phase 3 study in non-small cell lung cancer.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Brent Saunders' latest dermatology bet gets $20M for skin longevity

Brent Saunders was thinking a lot about skincare and longevity during the Covid-19 pandemic, shortly after he finished up the more than $60 billion sale of Allergan to AbbVie. After leaving the ...

More: Brent Saun&shy;ders was think&shy;ing a lot about skin&shy;care and longevi&shy;ty dur&shy;ing the Covid-19 pan&shy;dem&shy;ic, short&shy;ly af&shy;ter he fin&shy;ished up the more than $60 bil&shy;lion sale … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Brent Saunders was thinking a lot about skincare and longevity during the Covid-19 pandemic, shortly after he finished up the more than $60 billion sale of Allergan to AbbVie.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Flagship's Abiologics uses AI to build mirror-image proteins for new drugs

Abiologics, a startup founded by the life science venture firm Flagship Pioneering, has successfully used artificial intelligence to create proteins — and potentially, more durable drugs — made from mirror-image building blocks, the company told Endpoints News ...

More: Abi&shy;o&shy;log&shy;ics, a start&shy;up found&shy;ed by the life sci&shy;ence ven&shy;ture firm Flag&shy;ship Pi&shy;o&shy;neer&shy;ing, has suc&shy;cess&shy;ful&shy;ly used ar&shy;ti&shy;fi&shy;cial in&shy;tel&shy;li&shy;gence to cre&shy;ate pro&shy;teins — and po&shy;ten&shy;tial&shy;ly, more durable drugs — … Get free access to a limited number of articles, plus choose ne…
TL;DR: Abiologics, a startup founded by the life science venture firm Flagship Pioneering, has successfully used artificial intelligence to create proteins — and potentially, more durable drugs — made from mirror-image building blocks, the company told Endpoints News ...
Read original at Endpoints
Further reading: Genome.govBioRxivGenetic Engineering BasicsWikipedia

Long‑Range Gene Networks Uncover 641 New Schizophrenia‑Associated Genes

A new gene‑network modeling framework integrating cis and trans regulatory effects identifies 766 schizophrenia‑associated genes—641 previously missed—across six brain regions. The post Long‑Range Gene Networks Uncover 641 New Schizophrenia‑Associated Genes appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Long‑Range Gene Networks Uncover 641 New Schizophrenia‑Associated Genes. A new gene‑network modeling framework integrating cis and trans regulatory effects identifies 766 schizophrenia‑associated genes—641 previously missed—across six brain regions.
TL;DR: The post Long‑Range Gene Networks Uncover 641 New Schizophrenia‑Associated Genes appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

AI Discovers Potential Antimicrobial “Prionin” Peptides

Researchers used AI to discover antibiotic-like molecules inside prion and prion-like proteins, including candidates that reduced A. baumannii burden in mice, with efficacy comparable to polymyxin B in the model tested. The post AI Discovers Potential Antimicrobial “Prionin” Peptides appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Researchers used AI to discover antibiotic-like molecules inside prion and prion-like proteins, including candidates that reduced A. baumannii burden in mice, with efficacy comparable to polymyxin B in the model tested. The post AI Discovers Potential Antimicrobial “Prionin” Peptides appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post AI Discovers Potential Antimicrobial “Prionin” Peptides appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Exelixis’ Cabometyx successor fails primary endpoint in colorectal cancer trial amid FDA review

Exelixis’ next franchise in a drug, zanzalintinib, has hit a clinical setback, although at least two groups of analysts suggested that an FDA approval is still on the table.

More: A phase 3 trial for the next-generation multikinase inhibitor in patients with previously treated metastatic colorectal cancer (mCRC) failed to achieve statistical significance on a dual primary endpoint measuring overall survival in a subpopulation, Exelixis announced Monday.
TL;DR: Exelixis’ next franchise in a drug, zanzalintinib, has hit a clinical setback, although at least two groups of analysts suggested that an FDA approval is still on the table.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

HHS launches broad effort to expand and speed up clinical trials

The Trump administration is responding to a drumbeat of calls from the biotech and pharma industries to modernize and expedite clinical trials with a sweeping initiative across HHS. The department

More: The Trump ad&shy;min&shy;is&shy;tra&shy;tion is re&shy;spond&shy;ing to a drum&shy;beat of calls from the biotech and phar&shy;ma in&shy;dus&shy;tries to mod&shy;ern&shy;ize and ex&shy;pe&shy;dite clin&shy;i&shy;cal tri&shy;als with a sweep&shy;ing … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The Trump administration is responding to a drumbeat of calls from the biotech and pharma industries to modernize and expedite clinical trials with a sweeping initiative across HHS.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

AbbVie to Acquire Apogee Therapeutics for $10.9B

Apogee’s lead candidate zumilokibart, an IL-13 inhibitor also called APG777, is a long-acting treatment that, according to the company, holds “pipeline-in-a-product potential” because of the opportunity it has for treating a variety of immunology and inflammation (I&I) diseases for which the drug is under study. The post AbbVie to Acquire Apogee Therapeutics for $10.9B appeared first on GEN - Genetic Engineering and Biotechnology News .

More: AbbVie to Acquire Apogee Therapeutics for $10.9B. Apogee’s lead candidate zumilokibart, an IL-13 inhibitor also called APG777, is a long-acting treatment that, according to the company, holds “pipeline-in-a-product potential” because of the opportunity it has for treating a variety of immunology and inflammation (I&I) diseases for which the drug is under study.
TL;DR: The post AbbVie to Acquire Apogee Therapeutics for $10.9B appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Federal health agencies unveil plan to speed up phase 1 clinical trials by 6 to 12 months

As the biotech world flocks to San Diego today for the BIO International Convention, the Department of Health and Human Services has provided plenty of conversation fodder with the announcement of a series of efforts to regain ground on China’s surging early-stage clinical development capabilities.

More: In a call with journalists, Acting FDA Commissioner Kyle Diamantas and Jay Bhattacharya, M.D., Ph.D., director of the National Institutes of Health and acting director of the Centers for Disease Control and Prevention, sketched an outline of reforms meant to hasten phase 1 trials and encourage companies to conduct the studies in the U.S.
TL;DR: As the biotech world flocks to San Diego today for the BIO International Convention, the Department of Health and Human Services has provided plenty of conversation fodder with the announcement of a series of efforts to regain ground on China’s surging early-stage clinical development capabilities.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

After 'redesign,' WuXi Biologics sets new timeline for Massachusetts factory completion

A WuXi Biologics factory under construction in Massachusetts is slated to be completed in 2028 — a decade after the company first announced its plans for the site and about six years later than its original ...

More: A WuXi Bi&shy;o&shy;log&shy;ics fac&shy;to&shy;ry un&shy;der con&shy;struc&shy;tion in Mass&shy;a&shy;chu&shy;setts is slat&shy;ed to be com&shy;plet&shy;ed in 2028 — a decade af&shy;ter the com&shy;pa&shy;ny first an&shy;nounced its plans for … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: A WuXi Biologics factory under construction in Massachusetts is slated to be completed in 2028 — a decade after the company first announced its plans for the site and about six years later than its original ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

MapLight to discuss autism drug's future with FDA after Phase 2 miss

MapLight Therapeutics is holding to hope that there's a path forward for its autism drug despite the program flunking a mid-stage study. The biotech’s treatment, known as ML-004, didn't meet the Phase 2 trial’s primary ...

More: MapLight to discuss autism drug's future with FDA after Phase 2 miss. MapLight Therapeutics is holding to hope that there's a path forward for its autism drug despite the program flunking a mid-stage study. The biotech’s treatment, known as ML-004, didn't meet the Phase 2 trial’s primary ...
TL;DR: MapLight Therapeutics is holding to hope that there's a path forward for its autism drug despite the program flunking a mid-stage study.
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Lilly allies with BioArctic; Antengene and Insilico sign deals

Plus news about Denali, Nuvectis Pharma, Graph Therapeutics, GondolaBio and the Novo Nordisk Foundation. 🔗 Eli Lilly’s alliance with BioArctic: The Indianapolis drug giant will work with the Swedish biotech behind Eisai and Biogen’s ...

More: Lilly allies with BioArctic; Antengene and Insilico sign deals. Plus news about Denali, Nuvectis Pharma, Graph Therapeutics, GondolaBio and the Novo Nordisk Foundation. 🔗 Eli Lilly’s alliance with BioArctic: The Indianapolis drug giant will work with the Swedish biotech behind Eisai and Biogen’s ...
TL;DR: Plus news about Denali, Nuvectis Pharma, Graph Therapeutics, GondolaBio and the Novo Nordisk Foundation.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Merck's IBD drug from $10.8B Prometheus deal claims its first Phase 3 win

Merck’s $10.8 billion buyout of Prometheus Biosciences is showing its first signs of paying off. The lead program of that acquisition succeeded in its first Phase 3 trial, Merck said Monday morning, beating a placebo ...

More: Merck's IBD drug from $10.8B Prometheus deal claims its first Phase 3 win. Merck’s $10.8 billion buyout of Prometheus Biosciences is showing its first signs of paying off. The lead program of that acquisition succeeded in its first Phase 3 trial, Merck said Monday morning, beating a placebo ...
TL;DR: Merck’s $10.8 billion buyout of Prometheus Biosciences is showing its first signs of paying off.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Brain-Infiltrating T Cells Linked to Social Deficits in Autism Mouse Model

Brain-infiltrating γδ T cells accumulate in a genetic autism mouse model, contributing to social deficits. Removing or blocking these immune cells improved sociability, highlighting immune dysregulation as a potential therapeutic target. The post Brain-Infiltrating T Cells Linked to Social Deficits in Autism Mouse Model appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Brain-infiltrating γδ T cells accumulate in a genetic autism mouse model, contributing to social deficits. Removing or blocking these immune cells improved sociability, highlighting immune dysregulation as a potential therapeutic target.
TL;DR: The post Brain-Infiltrating T Cells Linked to Social Deficits in Autism Mouse Model appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Breast Milk Fatty Acid Shapes Immune Development in Mice

TVA exposure during breastfeeding reprogrammed immune cells to improve responses to pathogens. Mice that were nursed on TVA-enriched milk responded faster to infections with viruses or common bacteria, even into adulthood.  The post Breast Milk Fatty Acid Shapes Immune Development in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .

More: TVA exposure during breastfeeding reprogrammed immune cells to improve responses to pathogens. Mice that were nursed on TVA-enriched milk responded faster to infections with viruses or common bacteria, even into adulthood.  The post Breast Milk Fatty Acid Shapes Immune Development in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: Mice that were nursed on TVA-enriched milk responded faster to infections with viruses or common bacteria, even into adulthood.  The post Breast Milk Fatty Acid Shapes Immune Development in Mice appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Rethinking controls: The rise of VCGs in drug development

Virtual control groups are redefining study design—cutting animal use while advancing rigor and regulatory momentum.

More: Rethinking controls: The rise of VCGs in drug development. Virtual control groups are redefining study design—cutting animal use while advancing rigor and regulatory momentum.
TL;DR: Virtual control groups are redefining study design—cutting animal use while advancing rigor and regulatory momentum.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

In another reversal for rare disease field, FDA to reconsider Regenxbio gene therapy

In another sign that the FDA is easing its stance toward rare disease drug candidates under new leadership, the agency will reconsider Regenxbio’s gene therapy for an ultra-rare childhood disease, a reversal coming just about four months after a rejection.

More: Jun 22, 2026 10:26am REGENXBIO Cell & Gene Therapy FDA rare diseases In another sign that the FDA is easing its stance toward rare disease drug candidates under new leadership, the agency will reconsider Regenxbio’s gene therapy for an ultra-rare childhood disease, a reversal coming just about four months after a rejection.
TL;DR: In another sign that the FDA is easing its stance toward rare disease drug candidates under new leadership, the agency will reconsider Regenxbio’s gene therapy for an ultra-rare childhood disease, a reversal coming just about four months after a rejection.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Post-Hoc Live: Are the China hawks winning?

I don't know who will win the debate on China biotech in Washington, but I do know which voices are the loudest. Over the past few months, China hawks — those who want to put up ...

More: Post-Hoc Live: Are the China hawks winning?. I don't know who will win the debate on China biotech in Washington, but I do know which voices are the loudest. Over the past few months, China hawks — those who want to put up ...
TL;DR: I don't know who will win the debate on China biotech in Washington, but I do know which voices are the loudest.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Sanofi, Pangaea ink AI partnership deal to detect underdiagnosed genetic disease

French biopharma Sanofi inked a partnership deal with Pangaea Data to use its AI platform that helps detect Alpha-1 Antitrypsin Deficiency (AATD) that will be distributed to select healthcare systems and low-income community care clinics.

More: AATD is a genetic disorder where a person is unable to produce sufficient, properly formed or inactive amounts of the protein alpha-1 antitrypsin (AAT), which is generated by the liver to protect the lungs from inflammation and damage.
TL;DR: French biopharma Sanofi inked a partnership deal with Pangaea Data to use its AI platform that helps detect Alpha-1 Antitrypsin Deficiency (AATD) that will be distributed to select healthcare systems and low-income community care clinics.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

AbbVie inks $10.9B Apogee buyout to bag hotly tipped eczema prospect

AbbVie has struck a deal to buy Apogee Therapeutics for $10.9 billion. The deal will give AbbVie control of a late-phase eczema drug candidate that could pose a threat to Eli Lilly, Regeneron and Sanofi.

More: AbbVie inks $10.9B Apogee buyout to bag hotly tipped eczema prospect. AbbVie has struck a deal to buy Apogee Therapeutics for $10.9 billion. The deal will give AbbVie control of a late-phase eczema drug candidate that could pose a threat to Eli Lilly, Regeneron and Sanofi.
TL;DR: AbbVie has struck a deal to buy Apogee Therapeutics for $10.9 billion.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Regenxbio to resubmit Hunter syndrome gene therapy without new study

Regenxbio said that it plans to resubmit its Hunter syndrome gene therapy following another apparent walk back by the FDA after leadership departures. According to Regenxbio, the FDA told the biotech that its existing data ...

More: Regenxbio to resubmit Hunter syndrome gene therapy without new study. Regenxbio said that it plans to resubmit its Hunter syndrome gene therapy following another apparent walk back by the FDA after leadership departures. According to Regenxbio, the FDA told the biotech that its existing data ...
TL;DR: According to Regenxbio, the FDA told the biotech that its existing data ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Definium reports Phase 3 hit for LSD drug in severe form of depression

Definium Therapeutics said its LSD candidate significantly improved depression symptoms in a Phase 3 study in major depressive disorder (MDD), with data exceeding analyst expectations. The biotech’s drug, known as DT120, improved patients’ depression score ...

More: Definium reports Phase 3 hit for LSD drug in severe form of depression. Definium Therapeutics said its LSD candidate significantly improved depression symptoms in a Phase 3 study in major depressive disorder (MDD), with data exceeding analyst expectations. The biotech’s drug, known as DT120, improved patients’ depression score ...
TL;DR: The biotech’s drug, known as DT120, improved patients’ depression score ...
Read original at Endpoints
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

AbbVie makes $10.9B move for Apogee's long-acting I&I drug candidates

AbbVie is making its largest post-Allergan acquisition in a $10.9 billion move for immunology biotech Apogee Therapeutics. Apogee's long-acting IL-13 drug, called zumilokibart, is slated to enter Phase 3 for eczema later this year. The ...

More: AbbVie makes $10.9B move for Apogee's long-acting I&I drug candidates. AbbVie is making its largest post-Allergan acquisition in a $10.9 billion move for immunology biotech Apogee Therapeutics. Apogee's long-acting IL-13 drug, called zumilokibart, is slated to enter Phase 3 for eczema later this year.
TL;DR: AbbVie is making its largest post-Allergan acquisition in a $10.9 billion move for immunology biotech Apogee Therapeutics.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

A Sanofi alum looks to take on the TL1A field with $165M for Bionyra

A former Sanofi I&I development executive has brought together a who's who of investors and assembled three drug candidates from Chinese and US biotechs after scanning about 100 global assets. Frédéric Marrache, who spent much ...

More: A Sanofi alum looks to take on the TL1A field with $165M for Bionyra. A former Sanofi I&I development executive has brought together a who's who of investors and assembled three drug candidates from Chinese and US biotechs after scanning about 100 global assets. Frédéric Marrache, who spent much ...
TL;DR: A former Sanofi I&I development executive has brought together a who's who of investors and assembled three drug candidates from Chinese and US biotechs after scanning about 100 global assets.
Read original at Endpoints
Further reading: Genome.govNature BiotechBioTech PrimerWikipedia

Definium’s LSD formula produces ‘best data ever seen’ in a pivotal depression trial, CEO says

From its headquarters in the heart of New York City, Definium Therapeutics has dropped topline phase 3 data for its psychedelic answer to depression that is almost certain to keep the field’s hype train rolling.

More: The biotech’s LSD recipe, known as DT120 ODT, scored wins on all primary and key secondary endpoints of the 149-patient Emerge trial , Definium announced Monday, June 22, marking a reduction in depression symptoms not hit by competing medicines.
TL;DR: From its headquarters in the heart of New York City, Definium Therapeutics has dropped topline phase 3 data for its psychedelic answer to depression that is almost certain to keep the field’s hype train rolling.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Nura Bio gets $73.8M to advance SARM1 inhibitors for neurodegeneration

The neurodegenerative disease-focused company Nura Bio said Monday it has secured $73.8 million in a Series B raise to fund two programs through early clinical trials. The cash should support Nura’s clinical work over the ...

More: The neurodegenerative disease-focused company Nura Bio said Monday it has secured $73.8 million in a Series B raise to fund two programs through early clinical trials. The cash should support Nura’s clinical work over the ...
TL;DR: The neurodegenerative disease-focused company Nura Bio said Monday it has secured $73.8 million in a Series B raise to fund two programs through early clinical trials.
Read original at Endpoints
Further reading: Genome.govNature BiotechBioTech PrimerWikipedia

A 5-month sprint: Behind Pfizer’s $10B deal and Innovent’s global pharma ambition

Despite its massive $10.5 billion size and 12-drug scope, Pfizer’s oncology deal with Innovent Biologics took less than five months to forge, but not without undergoing some stress tests.

More: The deal talks started at the J.P. Morgan Healthcare Conference in San Francisco in January this year, Innovent CEO Michael Yu, Ph.D., told Fierce Biotech. Innovent has a long history of working with multinational pharma companies (MNCs), dating back to its decade-long collaboration with Eli Lilly that  began in 2015 and  added its seventh chapter in February.
TL;DR: Despite its massive $10.5 billion size and 12-drug scope, Pfizer’s oncology deal with Innovent Biologics took less than five months to forge, but not without undergoing some stress tests.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Insilico lands heavily backloaded $2.5B AI drug discovery deal with SK Biopharm

Insillico Medicine and SK Biopharmaceuticals have teamed up on an AI-enabled search for drug candidates targeting neuroimmune disorders in a deal that could be worth more than $2.5 billion.

More: But its terms adopt a heavily backloaded structure, with only $18 million in upfront and near-term milestone payments. Under the agreement, Insilico will leverage its Pharma.AI engine to design and optimize drug candidates, while SK will steer late-stage development and commercialization, utilizing the infrastructure it has built through its epilepsy therapy, Xcopri (cenobamat…
TL;DR: Insillico Medicine and SK Biopharmaceuticals have teamed up on an AI-enabled search for drug candidates targeting neuroimmune disorders in a deal that could be worth more than $2.5 billion.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

FDA Breakthrough Therapy and RMAT: Strategic Decisions That Can Accelerate Oncology Development

Explore how FDA Breakthrough Therapy and RMAT designations can create opportunities for oncology programs when backed by the right development strategy.

More: Jun 22, 2026 8:00am podcast Biotech Breakthrough Therapy and RMAT designations can be powerful accelerators in oncology development, but their value depends on more than eligibility alone. Plant also cautions that manufacturing, validation and analytical readiness must keep pace with accelerated clinical timelines.
TL;DR: Explore how FDA Breakthrough Therapy and RMAT designations can create opportunities for oncology programs when backed by the right development strategy.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

How data-driven diagnostic lab services drive precise clinical trial enrollment

Drug commercialization depends on reaching the right physicians at the right moment.

More: How data-driven diagnostic lab services drive precise clinical trial enrollment. Drug commercialization depends on reaching the right physicians at the right moment.
TL;DR: Drug commercialization depends on reaching the right physicians at the right moment.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Redefining what success looks like in PSC: The evolution of clinical trial endpoints

As understanding of rare cholestatic liver diseases has evolved, endpoint science and patient engagement may help shape future PSC research.

More: Redefining what success looks like in PSC: The evolution of clinical trial endpoints. As understanding of rare cholestatic liver diseases has evolved, endpoint science and patient engagement may help shape future PSC research.
TL;DR: As understanding of rare cholestatic liver diseases has evolved, endpoint science and patient engagement may help shape future PSC research.
Read original at Fiercebiotech
Further reading: PubMedGenome.govBioTech PrimerWikipedia

StockWatch: Positive Phase III Data Sells Investors on Intellia

The data was strong enough for Intellia to continue the rolling Biologics License Application (BLA) submission that it began in April. The company expects to complete the BLA filing by year’s end and hopes to gain FDA approval and launch lonvo-z in the first half of 2027. The post StockWatch: Positive Phase III Data Sells Investors on Intellia appeared first on GEN - Genetic Engineering and Biotechnology News .

More: The data was strong enough for Intellia to continue the rolling Biologics License Application (BLA) submission that it began in April. The company expects to complete the BLA filing by year’s end and hopes to gain FDA approval and launch lonvo-z in the first half of 2027.
TL;DR: The post StockWatch: Positive Phase III Data Sells Investors on Intellia appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Biopharma’s LGBTQ+ leaders; Novo Nordisk hacked?; and more

Welcome back to another edition of Endpoints Weekly! The summer solstice arrives this weekend — the northern hemisphere will reach its maximum tilt toward the sun at 4:24 a.m. Eastern time on Sunday morning. The days ...

More: Biopharma’s LGBTQ+ leaders; Novo Nordisk hacked?; and more. The summer solstice arrives this weekend — the northern hemisphere will reach its maximum tilt toward the sun at 4:24 a.m. Eastern time on Sunday morning.
TL;DR: Welcome back to another edition of Endpoints Weekly!
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Endpoints News History: 10 Years, Bootstrap to FT

Ten years of Endpoints News: no investors, a 50/50 split, profitable from day one. Co-founders Arsalan Arif and John Carroll on how the partnership held.

More: Endpoints News History: 10 Years, Bootstrap to FT. Ten years of Endpoints News: no investors, a 50/50 split, profitable from day one. Co-founders Arsalan Arif and John Carroll on how the partnership held.
TL;DR: Ten years of Endpoints News: no investors, a 50/50 split, profitable from day one.
Read original at Endpoints
Further reading: PubMedBioRxivBioTech PrimerWikipedia

FDA warning slams Zoll Medical with multiple quality control and reporting violations

Zoll Medical, the maker of devices and software focused on cardiopulmonary and respiratory conditions, was slammed in an FDA warning letter that outlined numerous quality control and medical device reporting violations.

More: The regulatory rebuke follows a Form 483 the Chelmsford, Massachusetts-based company was issued last year in the wake of an inspection held between February and April 2025. The agency said Zoll failed to adequately set up and maintain a proper corrective action plan (CAPA) in the wake of being issued a Form 483, and dropped the ball on procedures for validating device design.
TL;DR: Zoll Medical, the maker of devices and software focused on cardiopulmonary and respiratory conditions, was slammed in an FDA warning letter that outlined numerous quality control and medical device reporting violations.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

FDA vaccine advisors unanimously support Moderna's flu shot

Every member of a vaccine advisory panel for the FDA voted in favor of Moderna’s flu vaccine, after the product faced roadblocks from previous agency leadership. The Vaccines and Related Biological Products Advisory Committee voted ...

More: Every member of a vaccine advisory panel for the FDA voted in favor of Moderna’s flu vaccine, after the product faced roadblocks from previous agency leadership. The Vaccines and Related Biological Products Advisory Committee voted ...
TL;DR: Every member of a vaccine advisory panel for the FDA voted in favor of Moderna’s flu vaccine, after the product faced roadblocks from previous agency leadership.
Read original at Endpoints
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Impact of Early Life Adversity on Epigenome at Molecular Level Mapped in Macaques

Pairing the life histories of free-living macaques with genomic data from different tissues in adulthood, researchers have generated some of the clearest molecular evidence yet that early life adversity leaves a lasting, system-wide impression at the epigenome. The post Impact of Early Life Adversity on Epigenome at Molecular Level Mapped in Macaques appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Impact of Early Life Adversity on Epigenome at Molecular Level Mapped in Macaques. Pairing the life histories of free-living macaques with genomic data from different tissues in adulthood, researchers have generated some of the clearest molecular evidence yet that early life adversity leaves a lasting, system-wide impression at the epigenome.
TL;DR: The post Impact of Early Life Adversity on Epigenome at Molecular Level Mapped in Macaques appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Moderna’s flu candidate sails through FDA advisory committee in unanimous votes

As Moderna reshapes itself in the wake of the pandemic, the company on Thursday passed a key milestone in its bid to expand the reach of its mRNA platform to the massive influenza vaccination market.

More: Biotech Moderna’s flu candidate sails through FDA advisory committee in unanimous votes By Eric Sagonowsky Jun 18, 2026 3:03pm Moderna FDA Biotech As Moderna reshapes itself in the wake of the pandemic, the company on Thursday passed a key milestone in its bid to expand the reach of its mRNA platform to the massive influenza vaccination market.
TL;DR: As Moderna reshapes itself in the wake of the pandemic, the company on Thursday passed a key milestone in its bid to expand the reach of its mRNA platform to the massive influenza vaccination market.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Historic Biotech IPO, Merck, Protillion’s AI Deal, Testing a Lassa–Rabies Vaccine

In this episode of GEN 's Touching Base , editors talk about Parabilis Medicines’ groundbreaking IPO score, a new Merck collaboration, first-in-human Lassa–Rabies vaccine data, how CRISPR is attacking cancer cells, and mRNA delivery for DMD therapy. The post Historic Biotech IPO, Merck, Protillion’s AI Deal, Testing a Lassa–Rabies Vaccine appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Historic Biotech IPO, Merck, Protillion’s AI Deal, Testing a Lassa–Rabies Vaccine. In this episode of GEN 's Touching Base , editors talk about Parabilis Medicines’ groundbreaking IPO score, a new Merck collaboration, first-in-human Lassa–Rabies vaccine data, how CRISPR is attacking cancer cells, and mRNA delivery for DMD therapy.
TL;DR: The post Historic Biotech IPO, Merck, Protillion’s AI Deal, Testing a Lassa–Rabies Vaccine appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Treasury weighs screening investments in China biotech

Officials at the Treasury Department are looking at potential restrictions on US investments in China biotech, according to multiple sources familiar with the discussions. At least two sources told Endpoints News, based on direct conversations ...

More: Officials at the Treasury Department are looking at potential restrictions on US investments in China biotech, according to multiple sources familiar with the discussions. At least two sources told Endpoints News, based on direct conversations ...
TL;DR: Officials at the Treasury Department are looking at potential restrictions on US investments in China biotech, according to multiple sources familiar with the discussions.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings

IDBS and Alchemi partnered to connect AI agents with data in the IDBS Polar platform, creating a governed data foundation that enables reliable, compliant agentic AI use throughout drug development. The post IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings appeared first on GEN - Genetic Engineering and Biotechnology News .

More: IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings. IDBS and Alchemi partnered to connect AI agents with data in the IDBS Polar platform, creating a governed data foundation that enables reliable, compliant agentic AI use throughout drug development.
TL;DR: The post IDBS and Alchemi Agree to Accelerate AI-Driven Biopharma Regulatory Filings appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Novo Nordisk expands in China and Czech; Cellares boosts Series D by $50M

Plus more from Eisai and Siegfried. 🧱 Novo Nordisk's expansions: Novo Nordisk has invested around $380 million to expand its manufacturing facility in Bohumil, Central Bohemia, in the Czech Republic. Meanwhile ...

More: Novo Nordisk expands in China and Czech; Cellares boosts Series D by $50M. Plus more from Eisai and Siegfried. 🧱 Novo Nordisk's expansions: Novo Nordisk has invested around $380 million to expand its manufacturing facility in Bohumil, Central Bohemia, in the Czech Republic.
TL;DR: Plus more from Eisai and Siegfried.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

IRA's Medicare out-of-pocket cap increased access to drugs, study finds

Medication usage, particularly for the most expensive drugs, increased significantly shortly after the Medicare annual out-of-pocket cost cap took effect in January 2025, a study published in JAMA Health Forum on Thursday found. The results ...

More: Med&shy;ica&shy;tion us&shy;age, par&shy;tic&shy;u&shy;lar&shy;ly for the most ex&shy;pen&shy;sive drugs, in&shy;creased sig&shy;nif&shy;i&shy;cant&shy;ly short&shy;ly af&shy;ter the Medicare an&shy;nu&shy;al out-of-pock&shy;et cost cap took ef&shy;fect in Jan&shy;u&shy;ary 2025, a study … Get free access to a limited number of articles, plus choose newsletters to get straight…
TL;DR: Medication usage, particularly for the most expensive drugs, increased significantly shortly after the Medicare annual out-of-pocket cost cap took effect in January 2025, a study published in JAMA Health Forum on Thursday found.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Pfizer CFO to depart; GSK wins approval for UTI drug

Plus news about Apellis Pharmaceuticals, Servier, TORL BioTherapeutics, Verastem, Corcept Therapeutics, Legend Biotech, COUR Pharmaceuticals, cAMPfield Therapeutics and LabGenius Therapeutics. 👋 Pfizer’s CFO will depart in August: Dave Denton will leave ...

More: Pfizer CFO to depart; GSK wins approval for UTI drug. Plus news about Apellis Pharmaceuticals, Servier, TORL BioTherapeutics, Verastem, Corcept Therapeutics, Legend Biotech, COUR Pharmaceuticals, cAMPfield Therapeutics and LabGenius Therapeutics. 👋 Pfizer’s CFO will depart in August: Dave Denton will leave ...
TL;DR: Plus news about Apellis Pharmaceuticals, Servier, TORL BioTherapeutics, Verastem, Corcept Therapeutics, Legend Biotech, COUR Pharmaceuticals, cAMPfield Therapeutics and LabGenius Therapeutics.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

cAMPfield harvests $180M series A to advance oral IBD drug licensed from Newsoara

In another biotech born out of China’s “NewCo” model, cAMPfield Therapeutics has launched with a $180 million series A and a focus on oral medicines for inflammatory diseases.

More: Jun 18, 2026 10:34am inflammatory bowel disease China vTv Therapeutics biotech venture capital In another biotech born out of China’s “NewCo” model, cAMPfield Therapeutics has launched with a $180 million series A and a focus on oral medicines for inflammatory diseases.
TL;DR: In another biotech born out of China’s “NewCo” model, cAMPfield Therapeutics has launched with a $180 million series A and a focus on oral medicines for inflammatory diseases.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea

The trend continues in which big-name venture investors band together to back new companies with an experimental medicine developed by another biotech. RA Capital and Forbion — partners on a couple biotech launches in recent quarters — ...

More: RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea. The trend continues in which big-name venture investors band together to back new companies with an experimental medicine developed by another biotech. RA Capital and Forbion — partners on a couple biotech launches in recent quarters — ...
TL;DR: The trend continues in which big-name venture investors band together to back new companies with an experimental medicine developed by another biotech.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

China Sets Framework for Advanced Therapeutic Development

China’s Order 818 signals the country’s intent to accelerate local innovation and standardize the drug development environment, thereby becoming a more important player in advanced therapy development and manufacturing. The post China Sets Framework for Advanced Therapeutic Development appeared first on GEN - Genetic Engineering and Biotechnology News .

More: China Sets Framework for Advanced Therapeutic Development. China’s Order 818 signals the country’s intent to accelerate local innovation and standardize the drug development environment, thereby becoming a more important player in advanced therapy development and manufacturing.
TL;DR: The post China Sets Framework for Advanced Therapeutic Development appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Novocure’s electric fields therapy fails key glioblastoma study

Novocure reported Thursday morning that its electric fields device combined with chemoradiation failed to extend glioblastoma patients' lives in a Phase 3 study, dampening the company's hopes of expanding its product's ...

More: Novo&shy;cure re&shy;port&shy;ed Thurs&shy;day morn&shy;ing that its elec&shy;tric fields de&shy;vice com&shy;bined with chemora&shy;di&shy;a&shy;tion failed to ex&shy;tend glioblas&shy;toma pa&shy;tients’ lives in a Phase … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Novocure reported Thursday morning that its electric fields device combined with chemoradiation failed to extend glioblastoma patients' lives in a Phase 3 study, dampening the company's hopes of expanding its product's ...
Read original at Endpoints
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Perseverance, Persistence Key to CAR T Success, Say Ross Prize Winners Carl June and Michel Sadelain

The Ross Prize recognizes biomedical scientists whose discoveries have transformed how medicine is practiced. This year's recipients are well known in immunotherapy circles for their efforts to develop CAR T cells now used in cancer therapeutics. The post Perseverance, Persistence Key to CAR T Success, Say Ross Prize Winners Carl June and Michel Sadelain appeared first on GEN - Genetic Engineering and Biotechnology News .

More: The Ross Prize recognizes biomedical scientists whose discoveries have transformed how medicine is practiced. This year's recipients are well known in immunotherapy circles for their efforts to develop CAR T cells now used in cancer therapeutics.
TL;DR: The post Perseverance, Persistence Key to CAR T Success, Say Ross Prize Winners Carl June and Michel Sadelain appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Innoviva revives Lyndra's long-acting oral drug platform

A healthcare asset and royalties holding company is bringing a long-acting oral medicine approach back to life, resurrecting a drug delivery platform that had accumulated more than $380 million in venture and nonprofit funding over ...

More: A health&shy;care as&shy;set and roy&shy;al&shy;ties hold&shy;ing com&shy;pa&shy;ny is bring&shy;ing a long-act&shy;ing oral med&shy;i&shy;cine ap&shy;proach back to life, res&shy;ur&shy;rect&shy;ing a drug de&shy;liv&shy;ery plat&shy;form that had ac&shy;cu&shy;mu&shy;lat&shy;ed … Get free access to a limited number of articles, plus choose newsletters to get straight to your…
TL;DR: A healthcare asset and royalties holding company is bringing a long-acting oral medicine approach back to life, resurrecting a drug delivery platform that had accumulated more than $380 million in venture and nonprofit funding over ...
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Nirrin Technologies and S.T. Japan Partner on Next-Gen Protein Quantitation Tech

TALOS represents an advancement in protein quantitation, enabling rapid, consistent measurements with operational simplicity. These capabilities make it well-suited for modern bioprocessing workflows, from early process development through GMP manufacturing. The post Nirrin Technologies and S.T. Japan Partner on Next-Gen Protein Quantitation Tech appeared first on GEN - Genetic Engineering and Biotechnology News .

More: TALOS represents an advancement in protein quantitation, enabling rapid, consistent measurements with operational simplicity. The post Nirrin Technologies and S.T. Japan Partner on Next-Gen Protein Quantitation Tech appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: Japan Partner on Next-Gen Protein Quantitation Tech appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Novocure device fails to improve brain cancer patients’ survival in phase 3 test

Novocure’s tumor-treating electric fields device missed its primary endpoint in a late-stage glioblastoma trial.

More: Novocure device fails to improve brain cancer patients’ survival in phase 3 test. Novocure’s tumor-treating electric fields device missed its primary endpoint in a late-stage glioblastoma trial.
TL;DR: Novocure’s tumor-treating electric fields device missed its primary endpoint in a late-stage glioblastoma trial.
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Kardigan buttons up $400M upsized IPO to power heart drugs toward phase 3

Kardigan’s IPO haul has come in 14% above expectations, grossing $400 million after the cardiovascular disease biotech upsized the offering and hit the top end of its target range.

More: Having initially planned to offer an additional 3.5 million shares, the biotech bumped the overallotment up to 3.75 million shares late on Thursday. Before upsizing its offering, the company allocated $80 million to $90 million each to deanicamtiv and ataciguat, plus $40 million to $50 million to tonlamarsen.
TL;DR: Kardigan’s IPO haul has come in 14% above expectations, grossing $400 million after the cardiovascular disease biotech upsized the offering and hit the top end of its target range.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Nortiva purrs into action with long-acting Lynx platform salvaged from Langer startup

Innoviva has revealed the next steps for Langer Lab assets it rescued from Lyndra Therapeutics’ collapse, launching Nortiva Bio to develop long-acting oral medicines and pursue drug development alliances.

More: Lyndra  began winding down operations in March 2025 after failing to secure financing for a phase 3 trial. Months later, Innoviva, a biopharma company built on a royalty portfolio,  paid $10.2 million to acquire Lyndra’s long-acting drug delivery platform, Lynx. The Gates Foundation  provided a $5 million grant to support the development of the drug candidate late last year.
TL;DR: Innoviva has revealed the next steps for Langer Lab assets it rescued from Lyndra Therapeutics’ collapse, launching Nortiva Bio to develop long-acting oral medicines and pursue drug development alliances.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Eli Lilly's TuneLab hits 100 members, adding Chai's AI models

The leader behind TuneLab, Eli Lilly's first-of-its-kind AI initiative, had no idea what to expect when it launched. Lilly was trying something new by effectively offering biotechs free access to some of ...

More: Eli Lilly's TuneLab hits 100 members, adding Chai's AI models. The leader behind TuneLab, Eli Lilly's first-of-its-kind AI initiative, had no idea what to expect when it launched. Lilly was trying something new by effectively offering biotechs free access to some of ...
TL;DR: The leader behind TuneLab, Eli Lilly's first-of-its-kind AI initiative, had no idea what to expect when it launched.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Biogen inks $1B RayThera buyout to bag preclinical immunology assets

Biogen has struck a backloaded, $1 billion deal to buy RayThera, snagging a pipeline of anti-inflammatory drug candidates led by a prospect on the cusp of clinical development.

More: RayThera  raised a $110 million series A round last year to advance small molecules through preclinical development in immunology indications. The big biotech expects RayThera’s lead candidate to enter the clinic early in the third quarter. Rapt Therapeutics  axed a CCR4 inhibitor in 2024 after the FDA put its midphase trial on hold.
TL;DR: Biogen has struck a backloaded, $1 billion deal to buy RayThera, snagging a pipeline of anti-inflammatory drug candidates led by a prospect on the cusp of clinical development.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Super-potent synthetic opioids called nitazenes are spreading across the U.S.

Overdose deaths confirmed to involve nitazenes have risen sharply in the U.S., from 27 in 2020 to 409 in 2024, according to the CDC

More: In high school, Ashley Delgado dreamed of becoming a doctor and one day buying her father a Rolls-Royce. She had a high GPA, Taylor added, and did especially well in science and Latin.   In her mid-20s, Ashley suffered a leg injury and was prescribed OxyContin. But on an early summer morning in 2023, Ashley’s body was found on a dead-end street just outside the city.
TL;DR: Overdose deaths confirmed to involve nitazenes have risen sharply in the U.S., from 27 in 2020 to 409 in 2024, according to the CDC
Read original at Statnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Antifungal from F2G, Shionogi succeeds in Phase 3 study

F2G and Shionogi released positive Phase 3 data on Thursday morning, giving the companies a potentially clear path to approval for their antifungal drug. The companies said their treatment called olorofim performed as well as ...

More: F2G and Shionogi released positive Phase 3 data on Thursday morning, giving the companies a potentially clear path to approval for their antifungal drug. The companies said their treatment called olorofim performed as well as ...
TL;DR: F2G and Shionogi released positive Phase 3 data on Thursday morning, giving the companies a potentially clear path to approval for their antifungal drug.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

F2G, Shionogi prep regulatory push after novel antifungal passes ph. 3 test

F2G and Shionogi have released phase 3 data for the oral antifungal drug olorofim, demonstrating its non-inferiority compared with an existing drug for invasive aspergillosis.

More: In both treatment cohorts, patients received subsequent standard care based on their condition. The trial also revealed that drug-related treatment-emergent adverse events occurred in 35.8% of patients who received olorofim and 63.9% of those who received AmBisome.
TL;DR: F2G and Shionogi have released phase 3 data for the oral antifungal drug olorofim, demonstrating its non-inferiority compared with an existing drug for invasive aspergillosis.
Read original at Fiercebiotech
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Kardigan raises $400M in IPO to back three clinical-stage cardio drugs

More evidence has arrived that biotech IPOs are alive and well: A cardiology drug developer with three clinical-stage candidates just secured $400 million for its Nasdaq debut slated for Thursday. The New Jersey biotech, called ...

More: Kardigan raises $400M in IPO to back three clinical-stage cardio drugs. More evidence has arrived that biotech IPOs are alive and well: A cardiology drug developer with three clinical-stage candidates just secured $400 million for its Nasdaq debut slated for Thursday. The New Jersey biotech, called ...
TL;DR: The New Jersey biotech, called ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Biogen makes up to $1B deal for secretive anti-inflammatory biotech

Biogen will pay as much as $1 billion — “predominantly” in milestone payments — to acquire a San Diego biotech that has disclosed little about its pipeline. The startup, RayThera, debuted last year with a little more ...

More: Biogen makes up to $1B deal for secretive anti-inflammatory biotech. Biogen will pay as much as $1 billion — “predominantly” in milestone payments — to acquire a San Diego biotech that has disclosed little about its pipeline. The startup, RayThera, debuted last year with a little more ...
TL;DR: Biogen will pay as much as $1 billion — “predominantly” in milestone payments — to acquire a San Diego biotech that has disclosed little about its pipeline.
Read original at Endpoints
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Personalized Cartilage Graft Developed for Life-Threatening Infant Airway Narrowing

Researchers demonstrated in a preclinical model a new method of using decellularized cartilage with patient-specific cells to create grafts for enlarging pediatric airways narrowed as a result of severe subglottic stenosis. The post Personalized Cartilage Graft Developed for Life-Threatening Infant Airway Narrowing appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Personalized Cartilage Graft Developed for Life-Threatening Infant Airway Narrowing. Researchers demonstrated in a preclinical model a new method of using decellularized cartilage with patient-specific cells to create grafts for enlarging pediatric airways narrowed as a result of severe subglottic stenosis.
TL;DR: The post Personalized Cartilage Graft Developed for Life-Threatening Infant Airway Narrowing appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

FDA gives rejected drugs another chance in post-Makary era

Did you receive a complete response letter in the past year? Now may be the time for a resubmission. In the wake of FDA Commissioner Marty Makary's departure last month, the agency has already agreed ...

More: FDA gives rejected drugs another chance in post-Makary era. Did you receive a complete response letter in the past year? Now may be the time for a resubmission.
TL;DR: In the wake of FDA Commissioner Marty Makary's departure last month, the agency has already agreed ...
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

FDA warns telehealth companies over compounded GLP-1s

The FDA has issued a new batch of warning letters to 25 telehealth companies, accusing them of making false and misleading claims in their marketing of compounded GLP-1 weight loss drugs. The letters, issued earlier ...

More: The FDA has is&shy;sued a new batch of warn&shy;ing let&shy;ters to 25 tele&shy;health com&shy;pa&shy;nies, ac&shy;cus&shy;ing them of mak&shy;ing false and mis&shy;lead&shy;ing claims in their mar&shy;ket&shy;ing … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA has issued a new batch of warning letters to 25 telehealth companies, accusing them of making false and misleading claims in their marketing of compounded GLP-1 weight loss drugs.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

For biopharma manufacturing at speed and scale, the future is flexible

Biopharma development has long trended toward specialized and personalized therapies such as cell and gene therapies, antibody-drug conjugates, and monoclonal antibodies (mAbs), among others.

TL;DR: Biopharma development has long trended toward specialized and personalized therapies such as cell and gene therapies, antibody-drug conjugates, and monoclonal antibodies (mAbs), among others.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Analytics Map Purification Optimization Tradeoffs

Chromatography optimization should be considered not only in terms of quality, but also in terms of how each change affects processing time, congestion, and feasibility regarding stability-based time windows. The post Analytics Map Purification Optimization Tradeoffs appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Analytics Map Purification Optimization Tradeoffs. Chromatography optimization should be considered not only in terms of quality, but also in terms of how each change affects processing time, congestion, and feasibility regarding stability-based time windows.
TL;DR: The post Analytics Map Purification Optimization Tradeoffs appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Continuous Production Platform Offers New Gene Therapy Options

An independent U.K. innovation center has developed a continuous bioprocess to improve productivity and reduce costs of advanced therapies. The new platform performs as well, or better, than batch methods. The post Continuous Production Platform Offers New Gene Therapy Options appeared first on GEN - Genetic Engineering and Biotechnology News .

More: innovation center has developed a continuous bioprocess to improve productivity and reduce costs of advanced therapies. The new platform performs as well, or better, than batch methods. The post Continuous Production Platform Offers New Gene Therapy Options appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Continuous Production Platform Offers New Gene Therapy Options appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Bacterial Expression Tech Prompts NorthX and enGenes Collaboration

Interest in E.coli -based expression systems is growing as biopharma firms look for faster and cheaper ways of making proteins at commercial scale, prompting the new partnership between NorthX Biologics and enGenes Biotech. The post Bacterial Expression Tech Prompts NorthX and enGenes Collaboration appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Bacterial Expression Tech Prompts NorthX and enGenes Collaboration. Interest in E.coli -based expression systems is growing as biopharma firms look for faster and cheaper ways of making proteins at commercial scale, prompting the new partnership between NorthX Biologics and enGenes Biotech.
TL;DR: The post Bacterial Expression Tech Prompts NorthX and enGenes Collaboration appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Solvent Recovery Gains Ground in Bioprocessing

As bioprocessors face rising solvent costs, supply-chain disruptions, and mounting sustainability demands, solvent-recovery systems are emerging as strategic investments that reduce operating expenses, strengthen production resilience, and help companies meet increasingly ambitious environmental goals. The post Solvent Recovery Gains Ground in Bioprocessing appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Solvent Recovery Gains Ground in Bioprocessing. As bioprocessors face rising solvent costs, supply-chain disruptions, and mounting sustainability demands, solvent-recovery systems are emerging as strategic investments that reduce operating expenses, strengthen production resilience, and help companies meet increasingly ambitious environmental goals.
TL;DR: The post Solvent Recovery Gains Ground in Bioprocessing appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

UK waitlist for Novo's Wegovy pill triples in week after approval, major online pharmacy says

The waiting list at a UK online pharmacy for Novo Nordisk’s Wegovy pill now stands at 30,000 people a week after approval, in a sign of dramatic demand for the weight loss drug among patients ...

More: The wait&shy;ing list at a UK on&shy;line phar&shy;ma&shy;cy for No&shy;vo Nordisk’s We&shy;govy pill now stands at 30,000 peo&shy;ple a week af&shy;ter ap&shy;proval, in a sign … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The waiting list at a UK online pharmacy for Novo Nordisk’s Wegovy pill now stands at 30,000 people a week after approval, in a sign of dramatic demand for the weight loss drug among patients ...
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Hackers claim they stole Novo Nordisk AI models, manufacturing recipes

Novo Nordisk got robbed and is in the unenviable position of being extorted by the thieves. At stake, according to a group that has claimed responsibility for a cyberattack, are some of Novo's most valuable ...

More: Hackers claim they stole Novo Nordisk AI models, manufacturing recipes. Novo Nordisk got robbed and is in the unenviable position of being extorted by the thieves. At stake, according to a group that has claimed responsibility for a cyberattack, are some of Novo's most valuable ...
TL;DR: Novo Nordisk got robbed and is in the unenviable position of being extorted by the thieves.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

In second reversal, FDA gives uniQure a green light to seek accelerated approval

Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad. At the center of the debate, once again, is the ...

More: In second reversal, FDA gives uniQure a green light to seek accelerated approval. Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad. At the center of the debate, once again, is the ...
TL;DR: Regulatory flexibility appears to be back on the FDA’s menu following the departures of Marty Makary and Vinay Prasad.
Read original at Endpoints
Further reading: PubMedGenome.govBioTech PrimerWikipedia

Age-Related Inflammation Linked to R-Loop Nucleic Acids, Opens Therapies

When cells enter senescence, they begin releasing signals that contribute to chronic inflammation. Researchers have now pinpointed R-loops as a key component to modulating these inflammatory signals.  The post Age-Related Inflammation Linked to R-Loop Nucleic Acids, Opens Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .

More: When cells enter senescence, they begin releasing signals that contribute to chronic inflammation. Researchers have now pinpointed R-loops as a key component to modulating these inflammatory signals.  The post Age-Related Inflammation Linked to R-Loop Nucleic Acids, Opens Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: Researchers have now pinpointed R-loops as a key component to modulating these inflammatory signals.  The post Age-Related Inflammation Linked to R-Loop Nucleic Acids, Opens Therapies appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Vedana Therapeutics surfaces with $46M to develop next generation of migraine prevention therapies

Vedana Therapeutics has emerged from stealth with $46 million in series A financing aimed at advancing the company’s subcutaneously delivered antibodies for migraine prevention.

More: Biotech Vedana Therapeutics surfaces with $46M to develop next generation of migraine prevention therapies By Will Maddox Jun 17, 2026 9:48am Lundbeck migraine funding Slate Medicines Vedana Therapeutics has emerged from stealth with $46 million in series A financing aimed at advancing the company’s subcutaneously delivered antibodies for migraine prevention.
TL;DR: Vedana Therapeutics has emerged from stealth with $46 million in series A financing aimed at advancing the company’s subcutaneously delivered antibodies for migraine prevention.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

UniQure stock surges after FDA U-turn clears path to gene therapy filing

The FDA has pulled a U-turn on uniQure’s Huntington’s disease gene therapy, giving the biotech the OK to file for accelerated approval after previously demanding data from another trial.

More: After suffering the setback in March, uniQure arranged another meeting with the FDA to discuss the next steps. The biotech’s share price surged 80% to $48.51 in premarket trading on the back of the news. Former FDA leaders Marty Makary, M.D., and Vinay Prasad, M.D.
TL;DR: The FDA has pulled a U-turn on uniQure’s Huntington’s disease gene therapy, giving the biotech the OK to file for accelerated approval after previously demanding data from another trial.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Spot Bio launches with $40M to study mRNA therapy for muscular dystrophy

A startup with operations in California and China has quietly begun tests of a genetic medicine that could restore dystrophin, the vital muscle protein that is broken or missing in people born with Duchenne muscular ...

More: A start&shy;up with op&shy;er&shy;a&shy;tions in Cal&shy;i&shy;for&shy;nia and Chi&shy;na has qui&shy;et&shy;ly be&shy;gun tests of a ge&shy;net&shy;ic med&shy;i&shy;cine that could re&shy;store dy&shy;s&shy;trophin, the vi&shy;tal mus&shy;cle pro&shy;tein that … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: A startup with operations in California and China has quietly begun tests of a genetic medicine that could restore dystrophin, the vital muscle protein that is broken or missing in people born with Duchenne muscular ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Jazz turns to AbCellera for T cell engagers in up to $4.1B partnership

For much of its first decade, Canadian antibody developer AbCellera signed partnership after partnership, securing 40 biopharma alliances that led to more than a dozen clinical-stage drug candidates. Then, in 2023 ...

More: For much of its first decade, Cana&shy;di&shy;an an&shy;ti&shy;body de&shy;vel&shy;op&shy;er Ab&shy;Cellera signed part&shy;ner&shy;ship af&shy;ter part&shy;ner&shy;ship, se&shy;cur&shy;ing 40 bio&shy;phar&shy;ma al&shy;liances that led to more than a dozen … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: For much of its first decade, Canadian antibody developer AbCellera signed partnership after partnership, securing 40 biopharma alliances that led to more than a dozen clinical-stage drug candidates.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Triveni Bio raises $65M ahead of upcoming readouts on eczema drugs

Triveni Bio announced a $65 million Series C after its second asset for eczema entered clinical studies last month. The Series C was co-led by Ascenta Capital and Janus Henderson Investors and included Deep Track ...

More: Triveni Bio raises $65M ahead of upcoming readouts on eczema drugs. Triveni Bio announced a $65 million Series C after its second asset for eczema entered clinical studies last month. The Series C was co-led by Ascenta Capital and Janus Henderson Investors and included Deep Track ...
TL;DR: Triveni Bio announced a $65 million Series C after its second asset for eczema entered clinical studies last month.
Read original at Endpoints
Further reading: Genome.govBioRxivBioTech PrimerWikipedia

'Biopharma ecosystem is back to full health,' fueled by M&A: PwC

With pharma and life sciences deal values surpassing $65 billion in the first quarter, marking the strongest quarter in the industry since 2020, analysts from PwC have declared that the “biopharma ecosystem is back to full health.”

More: Pharma 'Biopharma ecosystem is back to full health,' fueled by M&A: PwC By Kevin Dunleavy Jun 17, 2026 5:00am biotech M&A IPO PwC With pharma and life sciences deal values surpassing $65 billion in Q1, marking the strongest quarter in the industry since 2020, analysts from PwC have declared that the “biopharma ecosystem is back to full health.
TL;DR: With pharma and life sciences deal values surpassing $65 billion in the first quarter, marking the strongest quarter in the industry since 2020, analysts from PwC have declared that the “biopharma ecosystem is back to full health.”
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Jazz, AbCellera strike TCE discovery and development deal worth up to $792M per drug

Jazz Pharmaceuticals is looking to bolster its oncology research bona fides via a partnership with AbCellera to discover and develop T-cell-engaging (TCE) antibodies that could result in up to $792 million in biobucks for each program that Jazz options.

More: Biotech Jazz, AbCellera strike TCE discovery and development deal worth up to $792M per drug By Will Maddox Jun 17, 2026 7:00am Jazz Pharmaceuticals AbCellera T Cells drug discovery Jazz Pharmaceuticals is looking to bolster its oncology research bona fides via a partnership with AbCellera to discover and develop T-cell-engaging (TCE) antibodies that could result in up to $792…
TL;DR: Jazz Pharmaceuticals is looking to bolster its oncology research bona fides via a partnership with AbCellera to discover and develop T-cell-engaging (TCE) antibodies that could result in up to $792 million in biobucks for each program that Jazz options.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Migraine biotech Vedana Therapeutics makes its debut with $46M Series A

Vedana Therapeutics has emerged from stealth with $46 million in Series A proceeds with the goal of developing treatments that could free patients from migraines entirely. Available treatments for migraine typically only reduce attack frequencies ...

More: Migraine biotech Vedana Therapeutics makes its debut with $46M Series A. Vedana Therapeutics has emerged from stealth with $46 million in Series A proceeds with the goal of developing treatments that could free patients from migraines entirely. Available treatments for migraine typically only reduce attack frequencies ...
TL;DR: Vedana Therapeutics has emerged from stealth with $46 million in Series A proceeds with the goal of developing treatments that could free patients from migraines entirely.
Read original at Endpoints
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Merck, Protillion Launch AI Drug Discovery Collaboration with Up-to-$510M in Milestone Payments

The collaboration, launched through a multi-target discovery collaboration and license agreement, is designed to combine Merck’s global expertise in discovering novel therapeutics with Protillion’s Prot-MaP ™ on-chip antibody discovery platform, short for Protein Display on a Massively Parallel Array. The post Merck, Protillion Launch AI Drug Discovery Collaboration with Up-to-$510M in Milestone Payments appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Merck, Protillion Launch AI Drug Discovery Collaboration with Up-to-$510M in Milestone Payments. The collaboration, launched through a multi-target discovery collaboration and license agreement, is designed to combine Merck’s global expertise in discovering novel therapeutics with Protillion’s Prot-MaP ™ on-chip antibody discovery platform, short for Protein Display on a Massi…
TL;DR: The post Merck, Protillion Launch AI Drug Discovery Collaboration with Up-to-$510M in Milestone Payments appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Pancreatic Cancer Cell Death Triggered by Caspase‑8 Blockade in Preclinical Models

KRAS‑mutant pancreatic cancer relies on caspase‑8 to evade necroptosis, according to a new study. Blocking caspase‑8 triggers cell death in mouse models and patient‑derived organoids, revealing a promising therapeutic vulnerability. The post Pancreatic Cancer Cell Death Triggered by Caspase‑8 Blockade in Preclinical Models appeared first on GEN - Genetic Engineering and Biotechnology News .

More: KRAS‑mutant pancreatic cancer relies on caspase‑8 to evade necroptosis, according to a new study. Blocking caspase‑8 triggers cell death in mouse models and patient‑derived organoids, revealing a promising therapeutic vulnerability.
TL;DR: The post Pancreatic Cancer Cell Death Triggered by Caspase‑8 Blockade in Preclinical Models appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Six Takeaways from the Danaher Bioprocessing Summit

The conference emphasized that future competitive advantage in biomanufacturing will come less from building additional capacity and more from increasing productivity, speed, and process intelligence across the development-to-manufacturing workflow. The post Six Takeaways from the Danaher Bioprocessing Summit appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Six Takeaways from the Danaher Bioprocessing Summit. The conference emphasized that future competitive advantage in biomanufacturing will come less from building additional capacity and more from increasing productivity, speed, and process intelligence across the development-to-manufacturing workflow.
TL;DR: The post Six Takeaways from the Danaher Bioprocessing Summit appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Single-Cell RNA Sequencing Reveals Gene Activity Changes in Crohn’s Disease

In a detailed cellular study of Crohn’s disease, researchers mapped how gene activity changes across more than 50 cell types in the gut and created an open resource, IBDverse, characterizing each cell type and those whose activity shifts in disease. The post Single-Cell RNA Sequencing Reveals Gene Activity Changes in Crohn’s Disease appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Single-Cell RNA Sequencing Reveals Gene Activity Changes in Crohn’s Disease. In a detailed cellular study of Crohn’s disease, researchers mapped how gene activity changes across more than 50 cell types in the gut and created an open resource, IBDverse, characterizing each cell type and those whose activity shifts in disease.
TL;DR: The post Single-Cell RNA Sequencing Reveals Gene Activity Changes in Crohn’s Disease appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

B cell therapy maker Be Bio stops hemophilia trial

Be Biopharma disclosed in a federal clinical trials listing that it has terminated its study of a hemophilia B therapy made by editing a patient’s own cells. It was one of ...

More: Be Bio&shy;phar&shy;ma dis&shy;closed in a fed&shy;er&shy;al clin&shy;i&shy;cal tri&shy;als list&shy;ing that it has ter&shy;mi&shy;nat&shy;ed its study of a he&shy;mo&shy;phil&shy;ia B ther&shy;a&shy;py made … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Be Biopharma disclosed in a federal clinical trials listing that it has terminated its study of a hemophilia B therapy made by editing a patient’s own cells.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

FDA raises no major red flags with Moderna's flu shot

The FDA provided tepid support of Moderna’s flu vaccine ahead of an advisory meeting but, more importantly, didn't appear to raise any major concerns that could hinder its prospects. In briefing documents

More: The FDA pro&shy;vid&shy;ed tepid sup&shy;port of Mod&shy;er&shy;na’s flu vac&shy;cine ahead of an ad&shy;vi&shy;so&shy;ry meet&shy;ing but, more im&shy;por&shy;tant&shy;ly, didn’t ap&shy;pear to raise any ma&shy;jor con&shy;cerns that … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA provided tepid support of Moderna’s flu vaccine ahead of an advisory meeting but, more importantly, didn't appear to raise any major concerns that could hinder its prospects.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Amenable FDA review bodes well for Moderna's mRNA flu shot ahead of adcomm grilling

With a panel of outside experts set to weigh in Thursday—and with a refusal-to-file fiasco with the FDA just barely in the rearview—Moderna and its contender for the United States’ first mRNA-based influenza vaccine are heading into a critical test this week.

More: Biotech Amenable FDA review bodes well for Moderna's mRNA flu shot ahead of adcomm grilling By Fraiser Kansteiner Jun 16, 2026 2:46pm Moderna Influenza influenza vaccine mRNA With a panel of outside experts set to weigh in Thursday—and with a refusal-to-file fiasco with the FDA just barely in the rearview—Moderna and its contender for the United States’ first mRNA-based influe…
TL;DR: With a panel of outside experts set to weigh in Thursday—and with a refusal-to-file fiasco with the FDA just barely in the rearview—Moderna and its contender for the United States’ first mRNA-based influenza vaccine are heading into a critical test this week.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Eli Lilly’s M&A spree continues with acquisition of non-opioid pain drugmaker 4E

Biotech Eli Lilly’s M&A spree continues with acquisition of non-opioid pain drugmaker 4E By Angus Liu Jun 16, 2026 2:34pm Eli Lilly M&A pain drug chronic pain Eli Lilly is taking another shot at the…

More: Biotech Eli Lilly’s M&A spree continues with acquisition of non-opioid pain drugmaker 4E By Angus Liu Jun 16, 2026 2:34pm Eli Lilly M&A pain drug chronic pain Eli Lilly is taking another shot at the pain market, continuing a recent M&A binge that shows no signs of slowing down.
TL;DR: Eli Lilly is taking another shot at the pain market, continuing a recent M&A binge that shows no signs of slowing down.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

FDA greenlights Colorado's drug import proposal

The FDA gave the go-ahead for Colorado to try importing cheaper drugs from Canada, but it remains to be seen how or when this would actually begin. In a letter Monday ...

More: The FDA gave the go-ahead for Col&shy;orado to try im&shy;port&shy;ing cheap&shy;er drugs from Cana&shy;da, but it re&shy;mains to be seen how or when this would … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: The FDA gave the go-ahead for Colorado to try importing cheaper drugs from Canada, but it remains to be seen how or when this would actually begin.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

FDA clears Dexcom’s Stelo OTC glucose monitor for use with children

The FDA gave the green light to Dexcom’s over-the-counter glucose monitor Stelo for children 2 years or older who don’t use insulin.

More: MedTech FDA clears Dexcom’s Stelo OTC glucose monitor for use with children By Joseph Keenan Jun 16, 2026 8:15am Dexcom FDA approval FDA continuous glucose monitoring system The FDA has given the green light to Dexcom’s popular over-the-counter glucose monitor Stelo for children two years or older who don’t use insulin. The device accounted for $130 million of Dexcom’s $4.
TL;DR: The FDA gave the green light to Dexcom’s over-the-counter glucose monitor Stelo for children 2 years or older who don’t use insulin.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Edgewise to advance heart drug into Phase 3 following mid-stage data update

Edgewise Therapeutics has shared plans to advance its drug candidate for a genetic heart disease into a registrational study on the back of updated Phase 2 data. The biotech said Tuesday ...

More: Edge&shy;wise Ther&shy;a&shy;peu&shy;tics has shared plans to ad&shy;vance its drug can&shy;di&shy;date for a ge&shy;net&shy;ic heart dis&shy;ease in&shy;to a reg&shy;is&shy;tra&shy;tional study on the back of up&shy;dat&shy;ed Phase … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Edgewise Therapeutics has shared plans to advance its drug candidate for a genetic heart disease into a registrational study on the back of updated Phase 2 data.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

PE firm Altaris scoops up AI drug development outfit Simulations Plus for $375M

As biopharma companies of all stripes devote more time and attention to AI-based drug discovery and development, healthcare PE firm Altaris is bolstering its presence in the field through M&A.

More: Biotech PE firm Altaris scoops up AI drug development outfit Simulations Plus for $375M By Eric Sagonowsky Jun 16, 2026 12:13pm Simulations Plus drug discovery drug development AI and Machine Learning As biopharma companies of all stripes devote more time and attention to AI-based drug discovery and development, healthcare PE firm Altaris is bolstering its presence in the fiel…
TL;DR: As biopharma companies of all stripes devote more time and attention to AI-based drug discovery and development, healthcare PE firm Altaris is bolstering its presence in the field through M&A.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill

Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies. 💸 Eli Lilly acquires another pain biotech: The Indianapolis pharma giant has made its 11th acquisition of the year, snapping up Austin, TX-based ...

More: Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill. Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies. 💸 Eli Lilly acquires another pain biotech: The Indianapolis pharma giant has made its 11th acquisition of the year, snapping up Austin, TX-based ...
TL;DR: Plus, news about Merck, MultiValent Biotherapies, Alvotech, enGene, Mirum, and Adaptive Biotechnologies.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Edgewise data power rival to BMS and Cytokinetics toward phase 3

Edgewise Therapeutics has reported phase 2 data on its cardiomyopathy prospect, keeping the biotech on track to start pivotal development of a would-be challenger to Bristol Myers Squibb and Cytokinetics.

More: Biotech Edgewise data power rival to BMS and Cytokinetics toward phase 3 despite investor doubts By Nick Paul Taylor Jun 16, 2026 10:39am cardiomyopathy Clinical Data heart disease Biotech Edgewise Therapeutics has  reported phase 2 data on its cardiomyopathy prospect, keeping the biotech on track to start pivotal development of a would-be challenger to Bristol Myers Squibb an…
TL;DR: Edgewise Therapeutics has reported phase 2 data on its cardiomyopathy prospect, keeping the biotech on track to start pivotal development of a would-be challenger to Bristol Myers Squibb and Cytokinetics.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Scramblase Dynamics Uncovered by Single-Vesicle Fluorescence Microscopy

A new single-protein analysis technique gives researchers newfound ability to study scramblases, physiologically important proteins that translocate phospholipids bidirectionally across cell membranes.   The post Scramblase Dynamics Uncovered by Single-Vesicle Fluorescence Microscopy appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Scramblases are key drug targets with roles in the assembly of cell membranes, modification of proteins with sugars, cell survival, muscle development and molecular trafficking. Traditionally, researchers purify scramblase proteins for further study using vesicles to record average scramblase activity.
TL;DR: A new single-protein analysis technique gives researchers newfound ability to study scramblases, physiologically important proteins that translocate phospholipids bidirectionally across cell membranes.   The post Scramblase Dynamics Uncovered by Single-Vesicle Fluorescence Microscopy appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

BioTrinity 2026 Showcases Delivery Technologies and Promising Therapeutic Candidates

All the technologies featured at BioTrinity 2026 have the goal of addressing unmet needs in areas like chronic wounds and ophthalmic diseases, and the associated companies highlighted their lead candidates. The post BioTrinity 2026 Showcases Delivery Technologies and Promising Therapeutic Candidates appeared first on GEN - Genetic Engineering and Biotechnology News .

More: BioTrinity 2026 Showcases Delivery Technologies and Promising Therapeutic Candidates. All the technologies featured at BioTrinity 2026 have the goal of addressing unmet needs in areas like chronic wounds and ophthalmic diseases, and the associated companies highlighted their lead candidates.
TL;DR: The post BioTrinity 2026 Showcases Delivery Technologies and Promising Therapeutic Candidates appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

iRhythm hit by cyberattack that compromised patient data, says operations unaffected

Medical device maker iRhythm has been hit by a cyberattack, but the company said the incident has not affected its core products, operations or ability to meet patient needs.

More: In a new SEC filing , the company said it first identified “unauthorized activity” on its systems June 8. The following day, iRhythm was contacted by a “threat actor” who claimed to have obtained “proprietary data, patient protected health information and other personal information.
TL;DR: Medical device maker iRhythm has been hit by a cyberattack, but the company said the incident has not affected its core products, operations or ability to meet patient needs.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Merck inks $510M biobucks data generation partnership with Protillion

AI drug design specialist Protillion has inked a $510 million biobucks collaboration and license agreement with Merck & Co. that brings together Protillion’s platform and Merck’s drug discovery expertise.

More: Merck inks $510M biobucks data generation partnership with Protillion. AI drug design specialist Protillion has inked a $510 million biobucks collaboration and license agreement with Merck & Co. that brings together Protillion’s platform and Merck’s drug discovery expertise.
TL;DR: AI drug design specialist Protillion has inked a $510 million biobucks collaboration and license agreement with Merck & Co.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Adaptive plots splitting Pfizer-partnered drug discovery unit from diagnostics business

Adaptive Biotechnologies is planning to separate its drug discovery and diagnostics businesses, outlining its intent to evaluate “strategic and structural alternatives” for the medicine wing of the company

More: Biotech Adaptive plots splitting Pfizer-partnered drug discovery unit from diagnostics business By Nick Paul Taylor Jun 16, 2026 9:24am Adaptive Biotechnologies minimal residual disease spinoff immune system Adaptive Biotechnologies is planning to separate its drug discovery and diagnostics businesses,  outlining its intent to evaluate “strategic and structural alternatives” f…
TL;DR: Adaptive Biotechnologies is planning to separate its drug discovery and diagnostics businesses, outlining its intent to evaluate “strategic and structural alternatives” for the medicine wing of the company
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

UCSF spinout Kopra Bio raises $9.1M to test virus therapy in brain cancer

Glioblastoma is notoriously good at evading the immune system, making it particularly resistant to immunotherapy, but now researchers may have found a clever workaround. Scientists at the University of California, San Francisco ...

More: UCSF spinout Kopra Bio raises $9.1M to test virus therapy in brain cancer. Glioblastoma is notoriously good at evading the immune system, making it particularly resistant to immunotherapy, but now researchers may have found a clever workaround. Scientists at the University of California, San Francisco ...
TL;DR: Glioblastoma is notoriously good at evading the immune system, making it particularly resistant to immunotherapy, but now researchers may have found a clever workaround.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Therapy-Resistant Residual Cancer Cell Dependencies Mapped

Researchers developed ResMap, a community resource providing both a standardized experimental framework and quantitative dataset for systematic comparison of persister cell vulnerabilities across cancer contexts. The post Therapy-Resistant Residual Cancer Cell Dependencies Mapped appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Therapy-Resistant Residual Cancer Cell Dependencies Mapped. Researchers developed ResMap, a community resource providing both a standardized experimental framework and quantitative dataset for systematic comparison of persister cell vulnerabilities across cancer contexts.
TL;DR: The post Therapy-Resistant Residual Cancer Cell Dependencies Mapped appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Silica Nanoparticles Induce Ferroptosis, Reprogram Immunity in Prostate Cancer Models

Ultrasmall fluorescent core‑shell silica nanoparticles—best known for their roles in medical imaging applications —are now showing surprising therapeutic muscle.

More: Silica Nanoparticles Induce Ferroptosis, Reprogram Immunity in Prostate Cancer Models. In a new preclinical study, researchers at Weill Cornell Medicine report that these engineered silica nanoparticles can directly kill prostate tumor cells while reawakening antitumor immunity , offering a potential new edge in a disease where immunotherapy has historically struggled.
TL;DR: Ultrasmall fluorescent core‑shell silica nanoparticles—best known for their roles in medical imaging applications —are now showing surprising therapeutic muscle.
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

When Process Design Fails: 5 Common Planning Gaps That Create Downstream Purification Bottlenecks

In this GEN webinar, our speakers will examine five common planning gaps that can contribute to bottlenecks, including single-source material dependency, raw material pack size selection, sensitive buffer designs, and single-use systems designed without realistic failure modes. The post When Process Design Fails: 5 Common Planning Gaps That Create Downstream Purification Bottlenecks appeared first on GEN - Genetic Engineering and Biotechnology News .

More: When Process Design Fails: 5 Common Planning Gaps That Create Downstream Purification Bottlenecks. In this GEN webinar, our speakers will examine five common planning gaps that can contribute to bottlenecks, including single-source material dependency, raw material pack size selection, sensitive buffer designs, and single-use systems designed without realistic failure modes.
TL;DR: The post When Process Design Fails: 5 Common Planning Gaps That Create Downstream Purification Bottlenecks appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

mRNA Flu Vaccine Shows Stronger, Longer-Lasting Immune Response

Moderna’s investigational mRNA flu vaccine generated broader, longer-lasting immune responses than a standard flu shot, potentially improving protection against evolving influenza strains and reducing vaccine mismatch. The post mRNA Flu Vaccine Shows Stronger, Longer-Lasting Immune Response appeared first on GEN - Genetic Engineering and Biotechnology News .

More: mRNA Flu Vaccine Shows Stronger, Longer-Lasting Immune Response. Moderna’s investigational mRNA flu vaccine generated broader, longer-lasting immune responses than a standard flu shot, potentially improving protection against evolving influenza strains and reducing vaccine mismatch.
TL;DR: The post mRNA Flu Vaccine Shows Stronger, Longer-Lasting Immune Response appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

ZoBio Introduces DNA-Encoded Library Service for Exploratory Drug Discovery Programs

ZoBio maintains that unlike transactional DEL screening approaches that focus solely on hit generation, its platform is designed to deliver biologically relevant, structurally characterized hit matter with clear potential for progression. The post ZoBio Introduces DNA-Encoded Library Service for Exploratory Drug Discovery Programs appeared first on GEN - Genetic Engineering and Biotechnology News .

More: ZoBio Introduces DNA-Encoded Library Service for Exploratory Drug Discovery Programs. ZoBio maintains that unlike transactional DEL screening approaches that focus solely on hit generation, its platform is designed to deliver biologically relevant, structurally characterized hit matter with clear potential for progression.
TL;DR: The post ZoBio Introduces DNA-Encoded Library Service for Exploratory Drug Discovery Programs appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

FDA plans to keep Makary priorities on trials, China, deputy says

PHILADELPHIA – Following the recent departures of FDA Commissioner Marty Makary and both of his center directors for drugs and biologics, the Trump administration will continue pushing their priorities as part of the next user ...

More: PHILADEL&shy;PHIA – Fol&shy;low&shy;ing the re&shy;cent de&shy;par&shy;tures of FDA Com&shy;mis&shy;sion&shy;er Mar&shy;ty Makary and both of his cen&shy;ter di&shy;rec&shy;tors for drugs and bi&shy;o&shy;log&shy;ics, the Trump ad&shy;min&shy;is&shy;tra&shy;tion will … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: PHILADELPHIA – Following the recent departures of FDA Commissioner Marty Makary and both of his center directors for drugs and biologics, the Trump administration will continue pushing their priorities as part of the next user ...
Read original at Endpoints
Further reading: PubMedBioRxivBioTech PrimerWikipedia

Takeda fortifies orexin potential with more Phase 3 data

With a formidable new competitor set to enter the orexin development race, Takeda is out with new data it hopes reinforces market-leading potential. The additional results from Takeda’s two Phase 3 studies of oveporexton, detailed ...

More: Takeda fortifies orexin potential with more Phase 3 data. With a formidable new competitor set to enter the orexin development race, Takeda is out with new data it hopes reinforces market-leading potential. The additional results from Takeda’s two Phase 3 studies of oveporexton, detailed ...
TL;DR: The additional results from Takeda’s two Phase 3 studies of oveporexton, detailed ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Elicio’s KRAS cancer vaccine fails in Phase 2, shares plummet

Elicio Therapeutics’ pancreatic cancer vaccine failed to improve outcomes in a mid-stage study, but the company is seeking funds to move ahead to a larger Phase 3 trial anyway. Elicio reported ...

More: Eli&shy;cio Ther&shy;a&shy;peu&shy;tics’ pan&shy;cre&shy;at&shy;ic can&shy;cer vac&shy;cine failed to im&shy;prove out&shy;comes in a mid-stage study, but the com&shy;pa&shy;ny is seek&shy;ing funds to move ahead to a larg&shy;er … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Elicio Therapeutics’ pancreatic cancer vaccine failed to improve outcomes in a mid-stage study, but the company is seeking funds to move ahead to a larger Phase 3 trial anyway.
Read original at Endpoints
Further reading: PubMedGenome.govBioTech PrimerWikipedia

Gan & Lee's Phase 3 obesity successes; J&J touts multiple myeloma data

Plus news about Sanofi, PharmaMar, Jazz, Rhythm Pharmaceuticals, Spyre and Zymeworks 🇨🇳 Another obesity readout from China: Gan & Lee Pharmaceuticals, a China-based insulin specialist, announced topline Phase 3 results last ...

More: Plus news about Sanofi, Phar&shy;ma&shy;Mar, Jazz, Rhythm Phar&shy;ma&shy;ceu&shy;ti&shy;cals, Spyre and Zymeworks 🇨🇳 An&shy;oth&shy;er obe&shy;si&shy;ty read&shy;out from Chi&shy;na: Gan & Lee Phar&shy;ma&shy;ceu&shy;ti&shy;cals, a Chi&shy;na-based in&shy;sulin spe&shy;cial&shy;ist … Get free access to a limited number of articles, plus choose newsletters to get straight to…
TL;DR: Plus news about Sanofi, PharmaMar, Jazz, Rhythm Pharmaceuticals, Spyre and Zymeworks 🇨🇳 Another obesity readout from China: Gan & Lee Pharmaceuticals, a China-based insulin specialist, announced topline Phase 3 results last ...
Read original at Endpoints
Further reading: Genome.govPubMedBioTech PrimerWikipedia

AI Predicts Gene Regulation for Drug Discovery Using Condensate Morphology

Deep learning unveils how drugs affect the dynamics of key structures within the cell. A new study maps condensate morphology to functional outcomes and sheds light on markers of health.  The post AI Predicts Gene Regulation for Drug Discovery Using Condensate Morphology appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Deep learning unveils how drugs affect the dynamics of key structures within the cell. A new study maps condensate morphology to functional outcomes and sheds light on markers of health.  The post AI Predicts Gene Regulation for Drug Discovery Using Condensate Morphology appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: A new study maps condensate morphology to functional outcomes and sheds light on markers of health.  The post AI Predicts Gene Regulation for Drug Discovery Using Condensate Morphology appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Neumora drug fails two more Phase 3 trials, biotech to lay off 35% of staff

The Really Big Neuroscience Company is proving to be a Really Big Flop with each passing update. Neumora Therapeutics will discontinue its lead depression drug after it failed another two Phase 3 studies, the company ...

More: Neumora drug fails two more Phase 3 trials, biotech to lay off 35% of staff. The Really Big Neuroscience Company is proving to be a Really Big Flop with each passing update. Neumora Therapeutics will discontinue its lead depression drug after it failed another two Phase 3 studies, the company ...
TL;DR: Neumora Therapeutics will discontinue its lead depression drug after it failed another two Phase 3 studies, the company ...
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Six leaders working on LGBTQ+ inclusion in biopharma

It’s been a tough 18 months for the LGBTQ+ community. The American Civil Liberties Union tracked 530 anti-LGBTQ bills across dozens of states this year. Nearly 40% of US workers say ...

More: Six leaders working on LGBTQ+ inclusion in biopharma. The American Civil Liberties Union tracked 530 anti-LGBTQ bills across dozens of states this year. Nearly 40% of US workers say ...
TL;DR: It’s been a tough 18 months for the LGBTQ+ community.
Read original at Endpoints
Further reading: PubMedBioRxivGenetic Engineering BasicsWikipedia

Intellia touts ‘paradigm-shifting’ phase 3 data for one-time HAE treatment

Six weeks after Intellia Therapeutics reported that it met its primary endpoint in a phase 3 trial of its in vivo gene-editing therapy lonvoguran ziclumeran (lonvo-z) for patients with hereditary angioedema (HAE), the company released additional positive data showing that the study also met its secondary endpoints with statistical and clinical significance.

More: Intellia President and Chief Executive Officer John Leonard, M.D., said the data represent the first phase 3 results demonstrating the promise of in vivo CRISPR gene editing, according to a June 13 release . HAE is a rare genetic condition that causes recurrent, unpredictable and potentially life-threatening swelling of the face, limbs, gastrointestinal tract and airways.
TL;DR: Six weeks after Intellia Therapeutics reported that it met its primary endpoint in a phase 3 trial of its in vivo gene-editing therapy lonvoguran ziclumeran (lonvo-z) for patients with hereditary angioedema (HAE), the company released additional positive data showing that the study also met its secondary endpoints with statistical and clinical significance.
Read original at Fiercebiotech
Further reading: PubMedBioRxivBioTech PrimerWikipedia

Neumora to lay off 35% of staff after navacaprant goes 0 for 3 in late-stage depression studies

Neumora's navacaprant has completed a clean sweep of trial misses in major depressive disorder.

More: Neumora to lay off 35% of staff after navacaprant goes 0 for 3 in late-stage depression studies. Neumora's navacaprant has completed a clean sweep of trial misses in major depressive disorder.
TL;DR: Neumora's navacaprant has completed a clean sweep of trial misses in major depressive disorder.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Traws defers midphase flu study after negative regulatory review

U.K. regulators have issued a “negative review” of Traws Pharma’s planned human influenza challenge study, forcing the biotech to defer a phase 2a trial tied to $20 million in funding.

More: Jun 15, 2026 9:19am Influenza MHRA antiviral Biotech U.K. The trial, which Traws  scheduled for this month, offered the company a faster way to generate TXM data than field studies. The FDA previously  put a planned TXM trial on hold over mutagenicity data concerns. 
TL;DR: regulators have issued a “negative review” of Traws Pharma’s planned human influenza challenge study, forcing the biotech to defer a phase 2a trial tied to $20 million in funding.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Lilly puts its stamp at #EHA26 with Jaypirca combo data in CLL, first clinical data from Ajax buyout

Eli Lilly made a push in blood cancer at this year’s European Hematology Association meeting in Stockholm over the weekend. The drugmaker presented data for Jaypirca combined with the standard of care in chronic lymphocytic ...

More: Lilly puts its stamp at #EHA26 with Jaypirca combo data in CLL, first clinical data from Ajax buyout. Eli Lilly made a push in blood cancer at this year’s European Hematology Association meeting in Stockholm over the weekend. The drugmaker presented data for Jaypirca combined with the standard of care in chronic lymphocytic ...
TL;DR: Eli Lilly made a push in blood cancer at this year’s European Hematology Association meeting in Stockholm over the weekend.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Soligenix axes lymphoma program after phase 3 setback, mulls M&A options

Soligenix has scrapped its cutaneous T-cell lymphoma program in the wake of a phase 3 setback, leaving the biotech focused on another rare disease prospect and considering strategic alternatives.

More: Soligenix started the phase 3 trial after the FDA  issued a refusal-to-file letter in response to the biotech’s request for approval. The company filed for approval based on a phase 3 trial that  hit its primary goal, but the FDA found the submission incomplete and  requested data from a second study.
TL;DR: Soligenix has scrapped its cutaneous T-cell lymphoma program in the wake of a phase 3 setback, leaving the biotech focused on another rare disease prospect and considering strategic alternatives.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

How NEC's AI and oral delivery system are redefining personalized cancer therapy

Neoantigen-based therapies are considered one of the most promising approaches in modern immuno-oncology. One challenge continues to limit the field: accurately identifying which neoantigens will generate meaningful anti-tumor immunity.

More: How NEC's AI and oral delivery system are redefining personalized cancer therapy. Neoantigen-based therapies are considered one of the most promising approaches in modern immuno-oncology. One challenge continues to limit the field: accurately identifying which neoantigens will generate meaningful anti-tumor immunity.
TL;DR: Neoantigen-based therapies are considered one of the most promising approaches in modern immuno-oncology.
Read original at Fiercebiotech
Further reading: PubMedBioRxivGenetic Engineering BasicsWikipedia

HMNC Brain Health raises $50M Series B to advance two depression drugs

HMNC Brain Health has secured $50 million in a Series B fundraise designed to support two psychiatry programs into mid-stage studies. The family-owned German drugmaker Medice led the Series B, which was also backed by ...

More: HMNC Brain Health raises $50M Series B to advance two depression drugs. HMNC Brain Health has secured $50 million in a Series B fundraise designed to support two psychiatry programs into mid-stage studies. The family-owned German drugmaker Medice led the Series B, which was also backed by ...
TL;DR: HMNC Brain Health has secured $50 million in a Series B fundraise designed to support two psychiatry programs into mid-stage studies.
Read original at Endpoints
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

StockWatch: Parabilis Medicines Makes Wall Street History with $770.5M IPO

Parabilis’ IPO surpasses the $625 million IPO carried out in April by Kailera Therapeutics, which topped the previous record-high among U.S. biotechs, the $604 million offering of Moderna in December 2018, two years before the messenger RNA (mRNA) vaccine developer won FDA emergency authorization for its COVID-19 vaccine. The post StockWatch: Parabilis Medicines Makes Wall Street History with $770.5M IPO appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Parabilis’ IPO surpasses the $625 million IPO carried out in April by Kailera Therapeutics, which topped the previous record-high among U.S. biotechs, the $604 million offering of Moderna in December 2018, two years before the messenger RNA (mRNA) vaccine developer won FDA emergency authorization for its COVID-19 vaccine.
TL;DR: The post StockWatch: Parabilis Medicines Makes Wall Street History with $770.5M IPO appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Collagen Resides Inside Cells in Liquid Condensate-Like Form

A study has shown that collagen exists inside cells as a liquid-like droplet rather than as a long, rigid rod-like structure, and outline a “liquid extrusion” hypothesis for collagen export that may have implications for wound healing, fibrosis, and cancer. The post Collagen Resides Inside Cells in Liquid Condensate-Like Form appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Collagen Resides Inside Cells in Liquid Condensate-Like Form. A study has shown that collagen exists inside cells as a liquid-like droplet rather than as a long, rigid rod-like structure, and outline a “liquid extrusion” hypothesis for collagen export that may have implications for wound healing, fibrosis, and cancer.
TL;DR: The post Collagen Resides Inside Cells in Liquid Condensate-Like Form appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Lilly unveils first clinical data behind $2.3B Ajax deal, showing JAK inhibitor works ‘right out of the gate’

Eli Lilly’s up-to-$2.3 billion acquisition of Ajax Therapeutics is facing its first major public test, and the initial clinical data show why the pharma giant made the bet.

More: Jun 13, 2026 11:15am Eli Lilly M&A myelofibrosis Incyte Eli Lilly’s up-to-$2.3 billion acquisition of Ajax Therapeutics is facing its first major public test, and the initial clinical data show why the pharma giant made the bet.  The Ajax acquisition was a familiar story of an early investor turned buyer.
TL;DR: Eli Lilly’s up-to-$2.3 billion acquisition of Ajax Therapeutics is facing its first major public test, and the initial clinical data show why the pharma giant made the bet.
Read original at Fiercebiotech
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Biopharma’s 2025 industry pay report; Parabilis sets industry record IPO; and more

Welcome back to Endpoints Weekly! This week, we opened nominations for our eighth annual Women in Biopharma report. We’re looking to profile 20 scientists, executives, founders and other enterprising women who are ...

More: Biopharma’s 2025 industry pay report; Parabilis sets industry record IPO; and more. This week, we opened nominations for our eighth annual Women in Biopharma report. We’re looking to profile 20 scientists, executives, founders and other enterprising women who are ...
TL;DR: Welcome back to Endpoints Weekly!
Read original at Endpoints
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

Merck brings Welireg-Keytruda combo to treat kidney cancer

Merck’s Welireg and Keytruda combination won approval as an adjuvant treatment for kidney cancer patients after surgery to remove all or part of the organ. The combination was approved Friday for ...

More: Mer&shy;ck’s Welireg and Keytru&shy;da com&shy;bi&shy;na&shy;tion won ap&shy;proval as an ad&shy;ju&shy;vant treat&shy;ment for kid&shy;ney can&shy;cer pa&shy;tients af&shy;ter surgery to re&shy;move all or … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Merck’s Welireg and Keytruda combination won approval as an adjuvant treatment for kidney cancer patients after surgery to remove all or part of the organ.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

Hantavirus One-Shot mRNA Vaccine Fully Protects in Syrian Hamster Model

Researchers at The University of Texas Medical Branch developed a single-dose mRNA vaccine that provided complete protection against the deadly Andes hantavirus infection in animal tests, potentially offering a rapid-response tool for future outbreaks. The post Hantavirus One-Shot mRNA Vaccine Fully Protects in Syrian Hamster Model appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Hantavirus One-Shot mRNA Vaccine Fully Protects in Syrian Hamster Model. Researchers at The University of Texas Medical Branch developed a single-dose mRNA vaccine that provided complete protection against the deadly Andes hantavirus infection in animal tests, potentially offering a rapid-response tool for future outbreaks.
TL;DR: The post Hantavirus One-Shot mRNA Vaccine Fully Protects in Syrian Hamster Model appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

SonoThera Raises $125M to Develop Ultrasound-Mediated Genetic Medicines

The company's proprietary platform combines an ultrasound-mediated delivery technology with payload engineering capabilities that support the development of DNA and RNA therapeutics, gene editing, and gene silencing approaches. The post SonoThera Raises $125M to Develop Ultrasound-Mediated Genetic Medicines appeared first on GEN - Genetic Engineering and Biotechnology News .

More: SonoThera Raises $125M to Develop Ultrasound-Mediated Genetic Medicines. The company's proprietary platform combines an ultrasound-mediated delivery technology with payload engineering capabilities that support the development of DNA and RNA therapeutics, gene editing, and gene silencing approaches.
TL;DR: The post SonoThera Raises $125M to Develop Ultrasound-Mediated Genetic Medicines appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Amgen and the FDA want two different outcomes for Tavneos. What will patients do?

Amgen has asked the FDA to review evidence that its drug Tavneos (avacopan), which treats a rare form of vasculitis, is worth keeping on the market, as the future of the drug remains in flux. ...

More: Am&shy;gen has asked the FDA to re&shy;view ev&shy;i&shy;dence that its drug Tavneos (ava&shy;co&shy;pan), which treats a rare form of vas&shy;culi&shy;tis, is worth keep&shy;ing on the … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Amgen has asked the FDA to review evidence that its drug Tavneos (avacopan), which treats a rare form of vasculitis, is worth keeping on the market, as the future of the drug remains in flux.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Eli Lilly invests in startup Abridge for clinical trial recruitment

Eli Lilly has invested in Abridge as the health tech startup expands into clinical trial recruitment and broadens its reach into the life sciences. The investment, made through Lilly’s venture arm, is meant to help ...

More: Eli Lilly invests in startup Abridge for clinical trial recruitment. Eli Lilly has invested in Abridge as the health tech startup expands into clinical trial recruitment and broadens its reach into the life sciences. The investment, made through Lilly’s venture arm, is meant to help ...
TL;DR: Eli Lilly has invested in Abridge as the health tech startup expands into clinical trial recruitment and broadens its reach into the life sciences.
Read original at Endpoints
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

‘I wouldn’t call it a blip’: Biotech IPOs here to stay after another record-breaking listing

Elon Musk's SpaceX may be igniting global headlines with the company's astronomical IPO, but biotech listings saw their own record-breaker this week.

More: ‘I wouldn’t call it a blip’: Biotech IPOs here to stay after another record-breaking listing. Elon Musk's SpaceX may be igniting global headlines with the company's astronomical IPO, but biotech listings saw their own record-breaker this week.
TL;DR: Elon Musk's SpaceX may be igniting global headlines with the company's astronomical IPO, but biotech listings saw their own record-breaker this week.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Enliven prices $400M offering; Jazz drug Zepzelca fails confirmatory study

Plus news about Caribou, Adial, and the Beneluxa Initiative. 💵 Enliven Therapeutics’ data and raise: The Burlingame, CA-based biotech priced a $400 million offering {$ELVN} Thursday night after saying earlier in ...

More: Enliven prices $400M offering; Jazz drug Zepzelca fails confirmatory study. Plus news about Caribou, Adial, and the Beneluxa Initiative. 💵 Enliven Therapeutics’ data and raise: The Burlingame, CA-based biotech priced a $400 million offering {$ELVN} Thursday night after saying earlier in ...
TL;DR: Plus news about Caribou, Adial, and the Beneluxa Initiative.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Biopharma's pay oddities of 2025: Executive perks and eccentricities

In combing through thousands of C-suite pay packages worth billions of dollars, it’s rare for a line item to stick out. Every once in a while, a biopharma company discloses perks that go beyond the ...

More: Biopharma's pay oddities of 2025: Executive perks and eccentricities. In combing through thousands of C-suite pay packages worth billions of dollars, it’s rare for a line item to stick out. Every once in a while, a biopharma company discloses perks that go beyond the ...
TL;DR: In combing through thousands of C-suite pay packages worth billions of dollars, it’s rare for a line item to stick out.
Read original at Endpoints
Further reading: BioRxivPubMedBioTech PrimerWikipedia

Guardant Health nabs FDA test approval to find patients for Boehringer’s new cancer drug

Boehringer Ingelheim’s Hernexeos has nabbed a companion diagnostic from Guardant Health after the FDA cleared its liquid biopsy test, Guardant360 CDx.

More: Hernexeos was approved last August for previously treated non-small cell lung cancer (NSCLC) patients who have relatively rare HER2 activating mutations in the tyrosine kinase domain. The mutated cancer type occurs in around 2% to 4% of NSCLC cases and affects around 40,000 patients globally. Now, Guardant Health can help find those patients.
TL;DR: Boehringer Ingelheim’s Hernexeos has nabbed a companion diagnostic from Guardant Health after the FDA cleared its liquid biopsy test, Guardant360 CDx.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

GSK took advantage of ASCO dip to get discount on Nuvalent

GSK’s $10.6 billion buyout of Nuvalent, announced Tuesday, was the largest in the company’s history. But did new CEO Luke Miels get a discount? At $124 a share, the price Miels paid ...

More: GSK took advantage of ASCO dip to get discount on Nuvalent. But did new CEO Luke Miels get a discount? At $124 a share, the price Miels paid ...
TL;DR: GSK’s $10.6 billion buyout of Nuvalent, announced Tuesday, was the largest in the company’s history.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Sciwind has two Western partners for its obesity drug, but is open to more

Sciwind Biosciences has already licensed its GLP-1 obesity drug ecnoglutide twice over — to Pfizer and Verdiva Bio — but it is not done yet. The Chinese biotech is seeking new partners for the rights it still ...

More: Sciwind has two Western partners for its obesity drug, but is open to more. Sciwind Biosciences has already licensed its GLP-1 obesity drug ecnoglutide twice over — to Pfizer and Verdiva Bio — but it is not done yet. The Chinese biotech is seeking new partners for the rights it still ...
TL;DR: Sciwind Biosciences has already licensed its GLP-1 obesity drug ecnoglutide twice over — to Pfizer and Verdiva Bio — but it is not done yet.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Novartis' phase 1/2 win tees up regulatory talks about dystrophy drug from $12B Avidity takeover

Novartis has reported a phase 1/2 win for one of the jewels of its $12 billion Avidity Biosciences buyout, setting the Swiss drugmaker up to talk to global regulatory agencies about the next steps for its dystrophy prospect.

More: Back in April, Novartis CEO Vas Narasimhan, M.D.,  told investors that the company planned to talk to the FDA about seeking accelerated approval based on the phase 1/2 data. Novartis’ topline phase 1/2 data take del-brax a step toward commercialization in facioscapulohumeral muscular dystrophy (FSHD).
TL;DR: Novartis has reported a phase 1/2 win for one of the jewels of its $12 billion Avidity Biosciences buyout, setting the Swiss drugmaker up to talk to global regulatory agencies about the next steps for its dystrophy prospect.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Laser‑Driven Phase Contrast Enhances Cryo‑EM Resolution of Small Proteins

Installed in a custom Titan Krios, the laser phase plate boosts small‑protein cryo‑EM by enhancing motion correction, early‑frame recovery, particle visualization, and 3D classification and alignment. The post Laser‑Driven Phase Contrast Enhances Cryo‑EM Resolution of Small Proteins appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Laser‑Driven Phase Contrast Enhances Cryo‑EM Resolution of Small Proteins. Installed in a custom Titan Krios, the laser phase plate boosts small‑protein cryo‑EM by enhancing motion correction, early‑frame recovery, particle visualization, and 3D classification and alignment.
TL;DR: The post Laser‑Driven Phase Contrast Enhances Cryo‑EM Resolution of Small Proteins appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

‘Not simply saving cost’: Inside Astellas CEO’s 5-year strategy to counter Xtandi’s patent cliff

Staring down a $6 billion patent cliff for its prostate cancer drug Xtandi, Astellas aims to counter the inevitable revenue decline with a 200 billion yen ($1.3 billion) cost-savings program anchored in its new five-year strategic plan. But to CEO Naoki Okamura, “it’s not simply saving the cost or reducing the headcount.”

More: Staring down a $6 billion patent cliff for its prostate cancer drug Xtandi, Astellas aims to counter the inevitable revenue decline with a 200 billion yen ($1.3 billion) cost-savings program anchored in its new five-year strategic plan. But to CEO Naoki Okamura, “it’s not simply saving the cost or reducing the headcount.”
TL;DR: Staring down a $6 billion patent cliff for its prostate cancer drug Xtandi, Astellas aims to counter the inevitable revenue decline with a 200 billion yen ($1.3 billion) cost-savings program anchored in its new five-year strategic plan.
Read original at Fiercebiotech
Further reading: PubMedBioRxivBioTech PrimerWikipedia

Drinking during pregnancy rose after 2020, new CDC data suggest

A new CDC report underscores that drinking during pregnancy, while generally thought of as a thing of the past, is still a matter of concern. 

More: Isabella is a chronic disease reporter writing about how the Trump administration is tackling the nation’s health epidemic — or not. Binge drinking is defined for women as having four or more drinks in a span of two hours. Having four or more drinks on any given day is classified as heavy drinking. 
TL;DR: A new CDC report underscores that drinking during pregnancy, while generally thought of as a thing of the past, is still a matter of concern. 
Read original at Statnews
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Potential Cocaine Addiction Targets Identified Through Genetic Mapping in Rats

A GWAS carried out in a genetically diverse population of rats identified genetic markers associated with compulsive cocaine use, and uncovered a potential new therapeutic target in the liver. The post Potential Cocaine Addiction Targets Identified Through Genetic Mapping in Rats appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Potential Cocaine Addiction Targets Identified Through Genetic Mapping in Rats. A GWAS carried out in a genetically diverse population of rats identified genetic markers associated with compulsive cocaine use, and uncovered a potential new therapeutic target in the liver.
TL;DR: The post Potential Cocaine Addiction Targets Identified Through Genetic Mapping in Rats appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

Roche nabs EU approval on label expansions for companion dx platform

Roche received approval through the EU’s In Vitro diagnostic regulation for several label expansions of its companion diagnostic platform that can identify a cancer patient's mismatch repair (MMR) status.

More: The approvals are for the drug giant’s Ventana MMR RxDx panel, an immunohistochemistry (IHC) companion diagnostic test that scans a patient’s genetic code. The test then evaluates a panel of MMR proteins in tumor that clinicians use for treatment decisions, the company said in a June 11 press release. When MMR is deficient, cells mutate, which can lead to cancer.
TL;DR: Roche received approval through the EU’s In Vitro diagnostic regulation for several label expansions of its companion diagnostic platform that can identify a cancer patient's mismatch repair (MMR) status.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

AI use is surging across HHS, jumping 148% at the FDA in 2025, Bipartisan Policy Center data finds

There was a big uptick in the use of AI across all HHS agencies in 2025, though analysts note some use cases may “reflect new reporting requirements instead of new deployments."

More: AI and Machine Learning AI use is surging across HHS, jumping 148% at the FDA in 2025, Bipartisan Policy Center data finds By Cailey Gleeson Jun 11, 2026 2:00pm Artificial Intelligence Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Centers for Disease Control and Prevention Artificial intelligence use cases across the federal health departmen…
TL;DR: There was a big uptick in the use of AI across all HHS agencies in 2025, though analysts note some use cases may “reflect new reporting requirements instead of new deployments."
Read original at Fiercebiotech
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

New mRNA Delivery Platform Restores Muscle Function in DMD Models

Engineered extracellular vesicles that deliver full-length DMD mRNA to skeletal muscle restored dystrophin production and significantly improved muscle strength and function in Duchenne muscular dystrophy models without notable toxicity. The post New mRNA Delivery Platform Restores Muscle Function in DMD Models appeared first on GEN - Genetic Engineering and Biotechnology News .

More: New mRNA Delivery Platform Restores Muscle Function in DMD Models. Engineered extracellular vesicles that deliver full-length DMD mRNA to skeletal muscle restored dystrophin production and significantly improved muscle strength and function in Duchenne muscular dystrophy models without notable toxicity.
TL;DR: The post New mRNA Delivery Platform Restores Muscle Function in DMD Models appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Novo reports data breach, tells clinical trial patients to 'remain vigilant'

As cybersecurity threats have proliferated across industries in recent years, biopharma companies have emerged as prominent targets, with intellectual property, patient data and other sensitive information at stake. Now, Novo Nordisk is the latest drug giant to report a data breach.

More: Novo reports data breach, tells clinical trial patients to 'remain vigilant'. As cybersecurity threats have proliferated across industries in recent years, biopharma companies have emerged as prominent targets, with intellectual property, patient data and other sensitive information at stake. Now, Novo Nordisk is the latest drug giant to report a data breach.
TL;DR: Now, Novo Nordisk is the latest drug giant to report a data breach.
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Predicta links with Spanish university to offer diagnostic for blood cancers

Predicta Biosciences, a precision oncology specialist, is teaming with the Clínica Universidad de Navarra’s CIMA Lab Diagnostics clinic to offer an assay focused on blood cancers.

More: The partnership combines Predicta’s GenoPredicta assay with CIMA’s flow cytometry capabilities. Flow cytometry can analyze the physical and chemical characteristics of cells or particles as they flow in a fluid stream and allows clinicians to rapidly count, examine, and sort thousands of individual cells per second.
TL;DR: Predicta Biosciences, a precision oncology specialist, is teaming with the Clínica Universidad de Navarra’s CIMA Lab Diagnostics clinic to offer an assay focused on blood cancers.
Read original at Fiercebiotech
Further reading: PubMedBioRxivGenetic Engineering BasicsWikipedia

Fighting Antimicrobial Resistance with Biomaterials and Phages

Antimicrobial resistance is a serious healthcare issue affecting the world and needs to be taken seriously. Unfortunately, the development of antibiotics is slow and mostly unsuccessful. A new approach is required. The post Fighting Antimicrobial Resistance with Biomaterials and Phages appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Antimicrobial resistance is a serious healthcare issue affecting the world and needs to be taken seriously. Unfortunately, the development of antibiotics is slow and mostly unsuccessful. The post Fighting Antimicrobial Resistance with Biomaterials and Phages appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Fighting Antimicrobial Resistance with Biomaterials and Phages appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Drugmakers are turning to logistics providers as trade disruptions linger, DHL exec says

DHL is in discussions with multiple major drugmakers who are looking for the logistics company to either take over their sites or access its resources, the company’s supply chain business CEO Hendrik Venter says. Pharma ...

More: DHL is in dis&shy;cus&shy;sions with mul&shy;ti&shy;ple ma&shy;jor drug&shy;mak&shy;ers who are look&shy;ing for the lo&shy;gis&shy;tics com&shy;pa&shy;ny to ei&shy;ther take over their sites or ac&shy;cess its re&shy;sources … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: DHL is in discussions with multiple major drugmakers who are looking for the logistics company to either take over their sites or access its resources, the company’s supply chain business CEO Hendrik Venter says.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Summit withdraws $500M offering, citing 'market conditions'

The current biotech environment can apparently support an industry-record IPO and simultaneously hamper efforts to raise half a billion dollars. Summit Therapeutics ditched plans for a $500 million public offering, the company disclosed in an ...

More: Summit withdraws $500M offering, citing 'market conditions'. The current biotech environment can apparently support an industry-record IPO and simultaneously hamper efforts to raise half a billion dollars. Summit Therapeutics ditched plans for a $500 million public offering, the company disclosed in an ...
TL;DR: The current biotech environment can apparently support an industry-record IPO and simultaneously hamper efforts to raise half a billion dollars.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Sensorion axes hearing loss program; Novartis' biomarker data in muscular dystrophy

Plus, news about Imaavy. 👂 Sensorion selects one hearing loss program, axes another: The biotech is ending the development of SENS-501 for OTOF-related hearing loss following a “strategic review.” As ...

More: Sensorion axes hearing loss program; Novartis' biomarker data in muscular dystrophy. Plus, news about Imaavy. 👂 Sensorion selects one hearing loss program, axes another: The biotech is ending the development of SENS-501 for OTOF-related hearing loss following a “strategic review.” As ...
TL;DR: Plus, news about Imaavy.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

Camurus’ second CRL for acromegaly drug; Teva details workforce cuts

Plus, news about a drug shortages report and Axplora: 🛑 Camurus has been hit with a second CRL: The rejection is for the drug CAM2029 in acromegaly due to problems at a third-party manufacturer. The ...

More: Plus, news about a drug short&shy;ages re&shy;port and Ax&shy;plo&shy;ra: 🛑 Ca&shy;mu&shy;rus has been hit with a sec&shy;ond CRL: The re&shy;jec&shy;tion is for the drug CAM2029 … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Plus, news about a drug shortages report and Axplora: 🛑 Camurus has been hit with a second CRL: The rejection is for the drug CAM2029 in acromegaly due to problems at a third-party manufacturer.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Biopharma pay report: Top-paid CSOs, CMOs of 2025

Biopharma’s top scientists and doctors don’t make nearly as much as CEOs, but some still took in eight-figure pay packages in 2025. As part of our series on industry compensation, Endpoints News looked across hundreds ...

More: Biopharma pay report: Top-paid CSOs, CMOs of 2025. Biopharma’s top scientists and doctors don’t make nearly as much as CEOs, but some still took in eight-figure pay packages in 2025. As part of our series on industry compensation, Endpoints News looked across hundreds ...
TL;DR: Biopharma’s top scientists and doctors don’t make nearly as much as CEOs, but some still took in eight-figure pay packages in 2025.
Read original at Endpoints
Further reading: PubMedGenome.govGenetic Engineering BasicsWikipedia

Fierce Biotech heading to UK to host event amid London Life Sciences Week

Fierce Biotech is returning to the U.K. in November for a day of curated discussions and networking at The Savoy, London’s iconic hotel.

More: Fierce Biotech heading to UK to host event amid London Life Sciences Week. Fierce Biotech is returning to the U.K. in November for a day of curated discussions and networking at The Savoy, London’s iconic hotel.
TL;DR: Fierce Biotech is returning to the U.K.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Kardigan plans $320M IPO for heart drugs as Nasdaq listings gain steam

Parabilis Medicines' record-breaking IPO will be a tough act to follow, but a drug developer with three late-stage cardio medicines is up for the challenge. It's led by a CEO who sold ...

More: Kardigan plans $320M IPO for heart drugs as Nasdaq listings gain steam. Parabilis Medicines' record-breaking IPO will be a tough act to follow, but a drug developer with three late-stage cardio medicines is up for the challenge. It's led by a CEO who sold ...
TL;DR: Parabilis Medicines' record-breaking IPO will be a tough act to follow, but a drug developer with three late-stage cardio medicines is up for the challenge.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

STAT+: ‘Synthetic lethality’ could trigger another round of biotech M&A

Proving out a "synthetic lethality" approach can help treat cancer will take a lot more work. It also might trigger some creative deal-making.

More: STAT+: ‘Synthetic lethality’ could trigger another round of biotech M&A. Proving out a "synthetic lethality" approach can help treat cancer will take a lot more work. It also might trigger some creative deal-making.
TL;DR: Proving out a "synthetic lethality" approach can help treat cancer will take a lot more work.
Read original at Statnews
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

STAT+: Enliven Therapeutics’ leukemia drug shows promise in new study

A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, new data show.

More: A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, including higher response rates in patients treated at an earlier stage of their disease.
TL;DR: A targeted drug from Enliven Therapeutics induced molecular responses in nearly half of patients with advanced leukemia, new data show.
Read original at Statnews
Further reading: Genome.govPubMedBioTech PrimerWikipedia

Cardiovascular-focused Kardigan plans to bring in cozy $320M haul from upcoming IPO

Kardigan has sewn up its IPO plans, with the cardiovascular biotech expecting to bring in a cozy $320 million from its planned Nasdaq listing.

More: Kardigan is led by CEO Tassos Gianakakos, who previously headed up the cardiovascular disease biotech MyoKardia for seven years. MyoKardia’s biggest achievement was mavacamten, a myosin inhibitor that persuaded Bristol Myers Squibb to buy the biotech for  $13.1 billion  in 2020. BMS secured approval for the drug as Camzyos two years later, and the therapy  brought in  $1.
TL;DR: Kardigan has sewn up its IPO plans, with the cardiovascular biotech expecting to bring in a cozy $320 million from its planned Nasdaq listing.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

Caribou boosts case that off-the-shelf CAR-T matches autologous drugs ahead of phase 3

Caribou Biosciences has linked its CAR-T cell therapy candidate to 17.1-month median progression-free survival, adding to evidence that the off-the-shelf treatment can match the efficacy of autologous products in lymphoma patients.

More: Last year, Caribou posted phase 1 data showing its allogeneic anti-CD19 CAR-T therapy achieves similar response and 12-month PFS rates to Bristol Myers Squibb’s Breyanzi and Novartis’ Yescarta.
TL;DR: Caribou Biosciences has linked its CAR-T cell therapy candidate to 17.1-month median progression-free survival, adding to evidence that the off-the-shelf treatment can match the efficacy of autologous products in lymphoma patients.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

Takeda's plaque psoriasis pill beats Bristol Myers' Sotyktu in Phase 3

Takeda’s $4 billion bet on an oral plaque psoriasis drug has paid off again, as the company reported the pill beat Bristol Myers Squibb’s Sotyktu in a head-to-head Phase 3 study. Zasocitinib induced complete skin ...

More: Take&shy;da’s $4 bil&shy;lion bet on an oral plaque pso&shy;ri&shy;a&shy;sis drug has paid off again, as the com&shy;pa&shy;ny re&shy;port&shy;ed the pill beat Bris&shy;tol My&shy;ers Squibb’s So&shy;tyk&shy;tu … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Takeda’s $4 billion bet on an oral plaque psoriasis drug has paid off again, as the company reported the pill beat Bristol Myers Squibb’s Sotyktu in a head-to-head Phase 3 study.
Read original at Endpoints
Further reading: Genome.govPubMedGenetic Engineering BasicsWikipedia

Neion Bio raises $23M Series A to make proteins from chicken eggs

Neion Bio has secured an oversubscribed $23 million Series A to further develop its technology that uses chicken eggs to make active pharmaceutical ingredients for biologic drugs. The funding round, which comes after Neion emerged ...

More: Neion Bio has secured an oversubscribed $23 million Series A to further develop its technology that uses chicken eggs to make active pharmaceutical ingredients for biologic drugs. The funding round, which comes after Neion emerged ...
TL;DR: Neion Bio has secured an oversubscribed $23 million Series A to further develop its technology that uses chicken eggs to make active pharmaceutical ingredients for biologic drugs.
Read original at Endpoints
Further reading: BioRxivGenome.govGenetic Engineering BasicsWikipedia

‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO

Novo Nordisk CEO Mike Doustdar told Fierce in an interview that he always believed the Big Pharma “did actually need to become more competitive.”

More: ‘I’m a lot more optimistic today’: Mike Doustdar tells Fierce about pivotal first year as Novo Nordisk CEO. Novo Nordisk CEO Mike Doustdar told Fierce in an interview that he always believed the Big Pharma “did actually need to become more competitive.”
TL;DR: Novo Nordisk CEO Mike Doustdar told Fierce in an interview that he always believed the Big Pharma “did actually need to become more competitive.”
Read original at Fiercebiotech
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Takeda’s TYK2 inhibitor beats Bristol Myers’ Sotyktu in phase 3 psoriasis showdown

Takeda has won the battle of the TYK2 inhibitors, toppling Bristol Myers Squibb’s Sotyktu to strengthen its hand ahead of an anticipated plaque psoriasis launch next year.

More: The phase 3 trial compared the TYK2 inhibitor zasocitinib, which Takeda  acquired for $4 billion upfront in 2022, to BMS' Sotyktu. At Week 16, Takeda reported PASI 100, indicating complete skin clearance, in “more than 35%” of patients on zasocitinib. Takeda has yet to post more detailed data from the trial but has shared other findings.
TL;DR: Takeda has won the battle of the TYK2 inhibitors, toppling Bristol Myers Squibb’s Sotyktu to strengthen its hand ahead of an anticipated plaque psoriasis launch next year.
Read original at Fiercebiotech
Further reading: Nature BiotechGenome.govGenetic Engineering BasicsWikipedia

Exclusive: Genentech closes infectious-disease unit in wave of research layoffs

Roche's Genentech underwent another round of layoffs this week in its early research and development group, Endpoints News has learned, which included shuttering two research units and the departure of several senior researchers. The exact ...

More: Roche’s Genen&shy;tech un&shy;der&shy;went an&shy;oth&shy;er round of lay&shy;offs this week in its ear&shy;ly re&shy;search and de&shy;vel&shy;op&shy;ment group, End&shy;points News has learned, which in&shy;clud&shy;ed shut&shy;ter&shy;ing two re&shy;search … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Roche's Genentech underwent another round of layoffs this week in its early research and development group, Endpoints News has learned, which included shuttering two research units and the departure of several senior researchers.
Read original at Endpoints
Further reading: PubMedBioRxivGenetic Engineering BasicsWikipedia

GSK to Acquire Nuvalent for $10.6B, Boosting Cancer Pipeline with Precision NSCLC Treatments

Nuvalent’s pipeline is headed by the ROS1 inhibitor zidesamtinib (NVL-520) and the ALK inhibitor eladalkib (NVL-655), which according to the company represent potential best-in-class, next-generation, highly selective treatments for NSCLC. Both are brain penetrant. The FDA has set target decision dates of September 18 for zidesamtinib and November 27 for neladalkib. The post GSK to Acquire Nuvalent for $10.6B, Boosting Cancer Pipeline with Precision NSCLC Treatments appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Nuvalent’s pipeline is headed by the ROS1 inhibitor zidesamtinib (NVL-520) and the ALK inhibitor eladalkib (NVL-655), which according to the company represent potential best-in-class, next-generation, highly selective treatments for NSCLC. The FDA has set target decision dates of September 18 for zidesamtinib and November 27 for neladalkib.
TL;DR: The post GSK to Acquire Nuvalent for $10.6B, Boosting Cancer Pipeline with Precision NSCLC Treatments appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Origins of First Eukaryotes Linked to Contributions from Multiple Bacteria and Giant Viruses

The study challenges the idea that cellular complexity emerged from a single evolutionary encounter, and point instead to a gradual process of interactions among bacteria and giant viruses lasting millions of years. The post Origins of First Eukaryotes Linked to Contributions from Multiple Bacteria and Giant Viruses appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Origins of First Eukaryotes Linked to Contributions from Multiple Bacteria and Giant Viruses. The study challenges the idea that cellular complexity emerged from a single evolutionary encounter, and point instead to a gradual process of interactions among bacteria and giant viruses lasting millions of years.
TL;DR: The post Origins of First Eukaryotes Linked to Contributions from Multiple Bacteria and Giant Viruses appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Brain Aneurysm Study Identifies Structural, Immune Markers of Rupture Risk

Findings from a new study suggest that macrophage accumulation and smooth muscle cell loss may contribute to brain aneurysm rupture, identifying potential markers that could help predict rupture risk and prevent stroke. The post Brain Aneurysm Study Identifies Structural, Immune Markers of Rupture Risk appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Brain Aneurysm Study Identifies Structural, Immune Markers of Rupture Risk. Findings from a new study suggest that macrophage accumulation and smooth muscle cell loss may contribute to brain aneurysm rupture, identifying potential markers that could help predict rupture risk and prevent stroke.
TL;DR: The post Brain Aneurysm Study Identifies Structural, Immune Markers of Rupture Risk appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Rare disease biotech Beren adds $300M from new financings

Anxiously awaiting an FDA decision this fall, Beren Therapeutics has added $300 million in new capital to help launch its rare disease drug. The biotech announced Wednesday that it raised $135 ...

More: Anxiously awaiting an FDA decision this fall, Beren Therapeutics has added $300 million in new capital to help launch its rare disease drug. The biotech announced Wednesday that it raised $135 ...
TL;DR: Anxiously awaiting an FDA decision this fall, Beren Therapeutics has added $300 million in new capital to help launch its rare disease drug.
Read original at Endpoints
Further reading: Nature BiotechPubMedGenetic Engineering BasicsWikipedia

Parabilis CEO Mathai Mammen on biotech's record IPO

Parabilis Medicines cemented the largest biotech IPO in industry history on Wednesday with its $670 million debut on the Nasdaq. But the Cambridge, MA-based drug developer won't be celebrating at the listing exchange in Times ...

More: Parabilis CEO Mathai Mammen on biotech's record IPO. Parabilis Medicines cemented the largest biotech IPO in industry history on Wednesday with its $670 million debut on the Nasdaq. But the Cambridge, MA-based drug developer won't be celebrating at the listing exchange in Times ...
TL;DR: Parabilis Medicines cemented the largest biotech IPO in industry history on Wednesday with its $670 million debut on the Nasdaq.
Read original at Endpoints
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia

Symeres Expands Spray Drying Capabilities at Its U.S. New Jersey Site

While Symeres is known for its drug discovery expertise, the expanded capability via spray drying further strengthens its ability to support complex molecules through development and into the clinic. The post Symeres Expands Spray Drying Capabilities at Its U.S. New Jersey Site appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Symeres Expands Spray Drying Capabilities at Its U.S. While Symeres is known for its drug discovery expertise, the expanded capability via spray drying further strengthens its ability to support complex molecules through development and into the clinic. The post Symeres Expands Spray Drying Capabilities at Its U.S.
TL;DR: New Jersey Site appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

In Silico Devices May Improve Drug Manufacturability

Augmenting experiments with in silico tools can help improve manufacturability and boost yields, says an AI technology company, in a conference debate about opportunities, challenges, and hopes for the future. The post <i>In Silico</i> Devices May Improve Drug Manufacturability appeared first on GEN - Genetic Engineering and Biotechnology News .

More: In Silico Devices May Improve Drug Manufacturability. Augmenting experiments with in silico tools can help improve manufacturability and boost yields, says an AI technology company, in a conference debate about opportunities, challenges, and hopes for the future.
TL;DR: The post <i>In Silico</i> Devices May Improve Drug Manufacturability appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

Gorilla Adenovirus Brings Natural Edge to Cancer Therapy

A gorilla adenovirus originally developed for vaccines is showing unexpected promise as a cancer therapy—one whose therapeutic properties may be baked into its native biology rather than engineered in. The post Gorilla Adenovirus Brings Natural Edge to Cancer Therapy appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Gorilla Adenovirus Brings Natural Edge to Cancer Therapy. A gorilla adenovirus originally developed for vaccines is showing unexpected promise as a cancer therapy—one whose therapeutic properties may be baked into its native biology rather than engineered in.
TL;DR: The post Gorilla Adenovirus Brings Natural Edge to Cancer Therapy appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Updated Amplification Tool Rapidly Detects Mycoplasma

New nucleic acid amplification technique provides both species breadth and sensitivity for Mycoplasma detection in biologics, making it viable for in-process control and release testing. The post Updated Amplification Tool Rapidly Detects Mycoplasma appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Updated Amplification Tool Rapidly Detects Mycoplasma. New nucleic acid amplification technique provides both species breadth and sensitivity for Mycoplasma detection in biologics, making it viable for in-process control and release testing. The post Updated Amplification Tool Rapidly Detects Mycoplasma appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Updated Amplification Tool Rapidly Detects Mycoplasma appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Innovative Tech Testing in Response to GMP Revisions

Changes to EU GMP rules on environmental testing and biopharmaceutical product quality are prompting manufacturers to adopt new verification processes. PIC/S support will see techniques like PUPSIT embraced in other markets. The post Innovative Tech Testing in Response to GMP Revisions appeared first on GEN - Genetic Engineering and Biotechnology News .

More: Changes to EU GMP rules on environmental testing and biopharmaceutical product quality are prompting manufacturers to adopt new verification processes. PIC/S support will see techniques like PUPSIT embraced in other markets. The post Innovative Tech Testing in Response to GMP Revisions appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post Innovative Tech Testing in Response to GMP Revisions appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Novartis and Orionis strike second molecular glue deal for $40M upfront

Novartis is doubling down on its partnership with Orionis Biosciences in a deal worth $40 million upfront and up to $1.4 billion spread across milestones. The Boston and Belgian biotech will ...

More: Novartis is doubling down on its partnership with Orionis Biosciences in a deal worth $40 million upfront and up to $1.4 billion spread across milestones. The Boston and Belgian biotech will ...
TL;DR: Novartis is doubling down on its partnership with Orionis Biosciences in a deal worth $40 million upfront and up to $1.4 billion spread across milestones.
Read original at Endpoints
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

ResMed snaps up Noctrix Health in $340M sleep tech deal

ResMed has closed its $340 million acquisition of Noctrix Health, picking up a wearable neuromodulation device that pushes the sleep tech giant beyond its core sleep apnea and respiratory care businesses.

More: The deal brings Noctrix’s Nidra Tonic Motor Activation therapy into ResMed’s portfolio. ResMed described restless legs syndrome as the third-most prevalent sleep disorder, behind insomnia and obstructive sleep apnea.
TL;DR: ResMed has closed its $340 million acquisition of Noctrix Health, picking up a wearable neuromodulation device that pushes the sleep tech giant beyond its core sleep apnea and respiratory care businesses.
Read original at Fiercebiotech
Further reading: BioRxivGenome.govBioTech PrimerWikipedia

SonoThera raises $125M for non-viral gene therapy approach

SonoThera has secured another $125 million to take its ultrasound-based gene therapy technology into the clinic. The company is focused on two lead programs in Duchenne muscular dystrophy and autosomal dominant polycystic kidney disease, and ...

More: SonoThera raises $125M for non-viral gene therapy approach. SonoThera has secured another $125 million to take its ultrasound-based gene therapy technology into the clinic. The company is focused on two lead programs in Duchenne muscular dystrophy and autosomal dominant polycystic kidney disease, and ...
TL;DR: SonoThera has secured another $125 million to take its ultrasound-based gene therapy technology into the clinic.
Read original at Endpoints
Further reading: Nature BiotechBioRxivBioTech PrimerWikipedia

J&J makes $1B upfront bet on emerging DAC space by netting Firefly Bio

Johnson & Johnson has paid $1 billion upfront to buy itself a degrader antibody conjugate platform via the acquisition of Firefly Bio.

More: DACs sit at the intersection of antibody-drug conjugates (ADCs) and targeted protein degraders (TPDs). The biotech is working on therapies specifically for KRAS-driven tumors. The company has previously referred to preclinical studies in both solid and liquid tumors, where a single administration of Firefly’s DACs showed “significant reductions in tumor volume at very low dose…
TL;DR: Johnson & Johnson has paid $1 billion upfront to buy itself a degrader antibody conjugate platform via the acquisition of Firefly Bio.
Read original at Fiercebiotech
Further reading: Genome.govNature BiotechGenetic Engineering BasicsWikipedia

Galmed acquires Colospan in $4.5M deal as it eyes $6B GI dx market

Galmed Pharmaceuticals acquired Colospan in a $4.5 million million deal as the Israel-based biotech looks to create a gastrointestinal platform targeting a dx sector valued at $6 billion.

More: MedTech Galmed acquires Colospan in $4.5M deal as it eyes $6B GI dx market By Joseph Keenan Jun 9, 2026 8:01am Galmed Pharmaceuticals M&A colon diagnostics Galmed Pharmaceuticals acquired Colospan in a $4.5 million deal as the Israel-based biotech looks to create a gastrointestinal platform targeting a dx sector valued at $6 billion.
TL;DR: Galmed Pharmaceuticals acquired Colospan in a $4.5 million million deal as the Israel-based biotech looks to create a gastrointestinal platform targeting a dx sector valued at $6 billion.
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

CeQur nabs $100M series E to fuel insulin patch commercialization

Swiss medtech CeQur has raised $100 million in a series E funding round for what it called its “most ambitious phase of commercial growth.”

More: MedTech CeQur nabs $100M series E to fuel insulin patch commercialization By Ben Adams Jun 9, 2026 9:20am CeQur insulin Devices MedTech Swiss medtech CeQur has raised $100 million in a new series E funding round for what it called its “most ambitious phase of commercial growth.
TL;DR: Swiss medtech CeQur has raised $100 million in a series E funding round for what it called its “most ambitious phase of commercial growth.”
Read original at Fiercebiotech
Further reading: Nature BiotechPubMedBioTech PrimerWikipedia

ADA: Novo’s Lange says ‘jury still out’ on CagriSema amid tough retatrutide comparisons

Even as industry watchers pit the two assets against one another, it’s too early to say whose next-generation incretin stands supreme between Novo Nordisk’s CagriSema and Eli Lilly’s retatrutide, Novo’s chief scientific officer suggested to Fierce at the ADA 2026 Scientific Sessions in New Orleans this past Sunday.

More: Biotech ADA: Novo’s Lange says ‘jury still out’ on CagriSema amid tough retatrutide comparisons By Fraiser Kansteiner Jun 10, 2026 11:10am Novo Nordisk Eli Lilly CagriSema American Diabetes Association Even as industry watchers pit the two obesity assets against one another, it’s too early to say whose next-generation incretin stands supreme between Novo Nordisk’s CagriSema an…
TL;DR: Even as industry watchers pit the two assets against one another, it’s too early to say whose next-generation incretin stands supreme between Novo Nordisk’s CagriSema and Eli Lilly’s retatrutide, Novo’s chief scientific officer suggested to Fierce at the ADA 2026 Scientific Sessions in New Orleans this past Sunday.
Read original at Fiercebiotech
Further reading: BioRxivPubMedGenetic Engineering BasicsWikipedia

GLP-1s may combat depression by multiplying a mood-boosting gut microbe

Since GLP-1 drugs like Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide took the world by storm for their potent treatment of diabetes and obesity, they have also been plagued by a clinical conundrum. In some studies, the peptides seem to possess antidepressant effects, while in others they’ve been linked to worse mental health and even increased suicidality.

More: Since GLP-1 drugs like Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide took the world by storm for their potent treatment of diabetes and obesity, they have also been plagued by a clinical conundrum. In some studies, the peptides seem to possess antidepressant effects, while in others they’ve been linked to worse mental health and even increased suicidality.
TL;DR: Since GLP-1 drugs like Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide took the world by storm for their potent treatment of diabetes and obesity, they have also been plagued by a clinical conundrum.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechGenetic Engineering BasicsWikipedia

Shattuck raises $75M; Servier inks neuro ASO pact with n-Lorem Foundation

Shattuck Labs initiates $75M public offering: The US biotech {$STTK} is selling over 10.5 million shares for $4 apiece, and issuing pre-funded warrants for certain investors. The offering is set to ...

More: Shat&shy;tuck Labs ini&shy;ti&shy;ates $75M pub&shy;lic of&shy;fer&shy;ing: The US biotech $STTK is sell&shy;ing over 10.5 mil&shy;lion shares for $4 apiece, and is&shy;su&shy;ing … Get free access to a limited number of articles, plus choose newsletters to get straight to your inbox.
TL;DR: Shattuck Labs initiates $75M public offering: The US biotech {$STTK} is selling over 10.5 million shares for $4 apiece, and issuing pre-funded warrants for certain investors.
Read original at Endpoints
Further reading: BioRxivNature BiotechGenetic Engineering BasicsWikipedia

Biotech pay analysis: 12 execs with $35M+ M&A golden parachutes

A dozen biotech executives took home nearly $1 billion worth of exit packages from selling their companies, an Endpoints News analysis found. The drug industry is undergoing a historic stretch of M&A, driven by many ...

More: Biotech pay analysis: 12 execs with $35M+ M&A golden parachutes. A dozen biotech executives took home nearly $1 billion worth of exit packages from selling their companies, an Endpoints News analysis found. The drug industry is undergoing a historic stretch of M&A, driven by many ...
TL;DR: A dozen biotech executives took home nearly $1 billion worth of exit packages from selling their companies, an Endpoints News analysis found.
Read original at Endpoints
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

Big Pharma-backed SonoThera sounds off with $125M series B for bubble-based genetic delivery

Bay Area biotech SonoThera is bubbling to a clinical boil after raising a $125 million series B with the backing of some of the biggest names in pharma.

More: Jun 10, 2026 10:48am Cell & Gene Therapy ultrasound Duchenne muscular dystrophy (DMD) Fundraising Bay Area biotech SonoThera is bubbling to a clinical boil after raising a $125 million series B with the backing of some of the biggest names in pharma.
TL;DR: Bay Area biotech SonoThera is bubbling to a clinical boil after raising a $125 million series B with the backing of some of the biggest names in pharma.
Read original at Fiercebiotech
Further reading: PubMedNature BiotechBioTech PrimerWikipedia

mRNA Tails Play Key Role in Folding Regulatory Proteins

While 3' UTRs have traditionally been dismissed as key regulators, a new study shows that these highly conserved mRNA tails facilitate the folding of intrinsically disordered proteins. The post mRNA Tails Play Key Role in Folding Regulatory Proteins appeared first on GEN - Genetic Engineering and Biotechnology News .

More: mRNA Tails Play Key Role in Folding Regulatory Proteins. While 3' UTRs have traditionally been dismissed as key regulators, a new study shows that these highly conserved mRNA tails facilitate the folding of intrinsically disordered proteins. The post mRNA Tails Play Key Role in Folding Regulatory Proteins appeared first on GEN - Genetic Engineering and Biotechnology News .
TL;DR: The post mRNA Tails Play Key Role in Folding Regulatory Proteins appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechGenome.govBioTech PrimerWikipedia

10x Genomics Acquires Proteintech Genomics, Expanding Proteomics Capablities

10x Genomics has acquired Proteintech Genomics for an undisclosed price, the companies said, in a deal driven by the buyer’s commitment to expanding its multiomics presence—in this case, by strategically expanding its proteomics capabilities. The post 10x Genomics Acquires Proteintech Genomics, Expanding Proteomics Capablities appeared first on GEN - Genetic Engineering and Biotechnology News .

More: 10x Genomics Acquires Proteintech Genomics, Expanding Proteomics Capablities. 10x Genomics has acquired Proteintech Genomics for an undisclosed price, the companies said, in a deal driven by the buyer’s commitment to expanding its multiomics presence—in this case, by strategically expanding its proteomics capabilities.
TL;DR: The post 10x Genomics Acquires Proteintech Genomics, Expanding Proteomics Capablities appeared first on GEN - Genetic Engineering and Biotechnology News .
Read original at Genengnews
Further reading: Nature BiotechBioRxivGenetic Engineering BasicsWikipedia