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Merck’s oral PCSK9 pill posts near-injectable LDL wins at AHA
Merck reported pivotal Phase 3 results showing its oral PCSK9 inhibitor produced LDL‑C reductions comparable to injectable PCSK9 antibodies, posting about a 59.7% drop in LDL at 24 weeks in...
Cogent’s twin wins push bezuclastinib toward NDA filings
Cogent Biosciences announced positive Phase 3 results for bezuclastinib in imatinib-resistant gastrointestinal stromal tumors (GIST), halving the risk of progression or death versus standard...
Roche’s BTK inhibitor clears two Phase 3 studies in multiple sclerosis
Roche reported two Phase 3 victories for its oral BTK inhibitor fenebrutinib across distinct multiple sclerosis populations, including relapsing and primary progressive forms. One trial met its...
Iambic raises $100M to scale AI-discovered drug pipeline
Iambic, an AI-driven biotech, closed an oversubscribed financing of more than $100 million to advance its portfolio of AI-discovered therapeutics and platform capabilities. The round drew...
FDA places Tenaya’s heart-gene trial on hold over immunosuppression standardization
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
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
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
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
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...
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
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
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
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
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
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
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
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
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
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
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...