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Latest Biotech News

FDA places Tenaya’s heart-gene trial on hold over immunosuppression standardization

November 11, 2025

The FDA has imposed a clinical hold on a Tenaya Therapeutics gene therapy study while the company standardizes immunosuppression regimens across trial sites. The agency’s action stops patient...

AI in primary care: zero-cost tool raises dementia detection by a third

November 11, 2025

A randomized clinical trial across more than 5,000 primary-care patients showed that combining the Quick Dementia Rating System (QDRS) with a Passive Digital Marker (PDM)—an EHR-based...

CRISPR edit halves cholesterol...early data hint at once‑and‑done therapy

November 11, 2025

Early clinical data from a CRISPR-based precision oncology/lipid program presented at a recent scientific meeting showed a one-time gene-editing intervention produced large, durable reductions in...

Pfizer wins Metsera for $10 billion – Novo bows out

November 11, 2025

Pfizer reached an amended agreement to acquire obesity drug developer Metsera in a deal valued at about $10 billion, ending a week‑long bidding contest with Novo Nordisk. Pfizer’s offer matched...

FDA moves to strip boxed warning from menopause HRT

November 11, 2025

The U.S. Food and Drug Administration announced it will work with manufacturers to remove longstanding boxed (black‑box) warnings from hormone replacement therapies for menopause. FDA officials,...

Merck’s oral PCSK9 draws pivotal data at AHA...

November 11, 2025

Merck presented pivotal Phase 3 results showing its oral PCSK9 inhibitor produced LDL‑C reductions comparable to injectable PCSK9 antibodies in large trials reported at the American Heart...

Lilly scoops retinal gene program: another push into genetic medicines

November 11, 2025

Eli Lilly acquired global rights to MeiraGTx’s AAV‑AIPL1 retinal gene therapy with an upfront payment reported at $75 million, adding a late‑stage program destined for regulatory filings in the...

Lilly deepens AI drug discovery tie with Insilico — $100M‑plus pact

November 11, 2025

Eli Lilly expanded its partnership with Insilico Medicine, converting a software licensing arrangement into a joint drug‑discovery collaboration with disclosed potential value above $100 million....

Roche’s BTK wins two phase 3s – MS program clears key hurdles

November 11, 2025

Roche reported two positive Phase 3 trials for its BTK inhibitor in multiple sclerosis, showing efficacy across relapsing disease and signals in primary progressive cohorts. The results mark a...

Cogent lines up NDAs after another Phase 3 win

November 11, 2025

Cogent Biosciences reported a Phase 3 victory for bezuclastinib in imatinib‑resistant gastrointestinal stromal tumors, halving the risk of progression or death versus sunitinib in the PEAK study...

FDA places hold on Tenaya’s heart‑gene trial over immunosuppression standardization

November 11, 2025

The FDA issued a clinical hold on a Tenaya Therapeutics gene therapy trial while the company standardizes immunosuppression protocols across study sites. Tenaya said it is addressing the agency’s...

Iambic raises $100M to advance AI‑discovered therapeutics and platform

November 11, 2025

Iambic Therapeutics closed an oversubscribed financing of over $100 million, backed by investors including ARK, Regeneron Ventures and Illumina Ventures to accelerate its pipeline of AI‑discovered...

Ultrasound clears intracranial debris and improves recovery in hemorrhagic stroke models

November 11, 2025

A study published in Nature Biotechnology showed therapeutic ultrasound clears intracranial debris after hemorrhagic stroke in mice, reducing inflammation and improving neurological recovery. The...

Pfizer wins Metsera — $10 billion obesity deal sealed

November 11, 2025

Pfizer agreed to acquire Metsera in a deal valued at about $10 billion after rival Novo Nordisk declined to increase its bid. The transaction secures Metsera’s clinical and preclinical obesity...

Merck’s oral PCSK9 pill: injectable-like LDL cuts reported

November 11, 2025

Merck presented pivotal data showing its oral PCSK9 candidate produced LDL-cholesterol reductions comparable to injectable PCSK9 inhibitors. In analyses reported at the American Heart Association,...

Roche’s BTK inhibitor posts Phase 3 wins — multiple sclerosis filings ahead

November 11, 2025

Roche reported two Phase 3 victories for its BTK inhibitor in multiple sclerosis, clearing the primary objectives in separate registrational studies. One trial showed non-inferiority to...

Cogent’s bezuclastinib halves progression risk — NDAs in view

November 11, 2025

Cogent Biosciences announced Phase 3 success for bezuclastinib in imatinib-resistant or -intolerant gastrointestinal stromal tumors (GIST), reporting a median progression-free survival of 16.5...

Lilly expands Insilico pact — AI moves from software to drug discovery

November 11, 2025

Eli Lilly upgraded its relationship with Insilico Medicine, converting a prior software licensing arrangement into a joint drug-discovery partnership. The companies disclosed the collaboration...

Lilly signs $1.2B RNAi pact with Sanegene — tissue-selective delivery in play

November 11, 2025

Eli Lilly entered a discovery and option collaboration with Suzhou Sanegene Bio centered on Sanegene’s Ligand and Enhancer Assisted Delivery (LEAD) tissue‑selective RNAi technology. The agreement...

Lilly buys MeiraGTx retinal program — $75 million upfront for LCA4 gene therapy

November 11, 2025

Eli Lilly acquired global rights to MeiraGTx’s AAV‑AIPL1 gene therapy for Leber congenital amaurosis 4 (LCA4) for $75 million up front. The program is on track for U.S. and European regulatory...