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Roche’s BTK wins broaden MS portfolio — mixed questions on data depth
Roche announced two Phase 3 successes for its BTK inhibitor in multiple sclerosis, showing efficacy in both relapsing and primary progressive forms. Company statements emphasized the drug’s...
Gene‑therapy ecosystem tests capacity and oversight — Tenaya hold, Catalent cuts
Regulatory and manufacturing strains surfaced this week: the FDA placed Tenaya Therapeutics’ heart‑disease gene therapy trial on hold while the company standardizes immunosuppression practices...
Iambic raises $100M as AI‑discovered drug firm scales programs and deals
Iambic closed an oversubscribed financing that brought in over $100 million to advance its AI‑discovered therapeutics and platform technologies, with participation from strategic life‑science...
Metsera auction ends: Pfizer lands obesity play at $10B
Pfizer agreed to acquire Metsera in a deal valuing the obesity drug developer at about $10 billion, ending a week-long bidding contest with Novo Nordisk. Pfizer’s amended offer matched rival bids...
Lilly bulks up genetic medicines: eye gene therapy and RNAi pact
Eli Lilly expanded its genetic-medicine footprint with two transactions this week: it paid for global rights to MeiraGTx’s retinal AAV program targeting LCA4 and struck a $1.2 billion research...
FDA reverses course: boxed warnings to be removed from HRT labels
The U.S. Food and Drug Administration announced it will work with manufacturers to remove boxed warnings on hormone replacement therapies (HRTs) used for menopause, concluding that the historical...
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...