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GLP‑1 supply and science: USP standards released as real‑world nonresponse questions rise
The U.S. Pharmacopeia released analytical reference materials and guidance to help manufacturers ensure purity and detect product‑ and process‑related impurities for GLP‑1 peptides amid surging...
Revvity leans on newborn screening to drive diagnostics growth
Revvity reported third‑quarter diagnostics revenue growth driven by its newborn screening business and immunodiagnostics, citing CE marking for an updated lysosomal storage disease panel and a...
Novartis to buy Avidity for $12B — bet on RNA neuromuscular drugs
Novartis agreed to acquire Avidity Biosciences for roughly $12 billion, taking ownership of three late-stage antibody-oligonucleotide conjugate (AOC) programs aimed at Duchenne muscular dystrophy,...
Intellia pauses CRISPR trials after liver toxicity hospitalisation
Intellia Therapeutics halted enrollment and dosing across two late‑stage CRISPR trials following a volunteer’s hospitalization with severe liver injury linked to its transthyretin amyloidosis...
Zenas’ obexelimab slashes new MS lesions — a convincing mid‑stage readout
Zenas Biopharma reported that obexelimab reduced the cumulative number of new gadolinium‑enhancing brain lesions by about 95% over 12 weeks in a Phase 2 trial in relapsing multiple sclerosis. The...
Health Canada clears lecanemab for early Alzheimer’s — conditional authorization
Health Canada issued a Notice of Compliance with Conditions for LEQEMBI (lecanemab), authorizing Eisai and Biogen’s monoclonal antibody for adults with mild cognitive impairment or mild dementia...
FDA approves Bayer’s non‑hormonal menopause pill Lynkuet — new competition
The FDA approved Lynkuet, Bayer’s once‑daily non‑hormonal oral therapy for moderate‑to‑severe vasomotor symptoms of menopause. Approval relied on three late‑stage trials that demonstrated...
Hemab raises $157M to push coagulation disorder pipeline forward
Hemab Therapeutics closed a $157 million financing to advance a portfolio of clotting‑disorder programs, including two candidates already in clinical testing. The Series C was led by Sofinnova...
BridgeBio pivots filing plans after Phase 3 rare‑disease success
BridgeBio reported positive interim Phase 3 data in a rare muscular dystrophy study and said it will adjust its regulatory strategy and meet with the FDA to discuss a path to approval. The company...
Guardant Health and Zephyr AI team up to accelerate genomic biomarker discovery
Guardant Health struck a strategic partnership with Zephyr AI to combine Guardant’s multimodal molecular data from its oncology testing platform with Zephyr’s machine‑learning analytics. The...
MIT’s BoltzGen expands AI drug design — open‑source model for therapeutic creation
MIT researchers released BoltzGen, an update to their Boltz series that moves beyond structure prediction toward generalizable therapeutic design across modalities including nanobodies,...
MapLight launches with $250M IPO to bankroll schizophrenia drug challenger
MapLight Therapeutics priced a $250 million initial public offering to fund development of a small‑molecule rival to Bristol Myers Squibb’s schizophrenia treatment Cobenfy. The company said...
Intellia pauses phase 3 trials: liver safety signal halts dosing
Intellia Therapeutics halted dosing and enrollment in two late-stage CRISPR gene‑editing trials after a participant was hospitalized with severe liver injury. The company stopped screening and...
Novartis buys Avidity for $12B — three late‑stage RNA programs added
Novartis agreed to acquire Avidity Biosciences for about $12 billion in cash, securing three late‑stage RNA‑based therapeutic programs for muscular dystrophies and related neuromuscular...
BridgeBio eyes FDA after Phase 3 win — filing plans shift
BridgeBio reported positive Phase 3 results for a rare‑disease candidate and is moving to adjust its regulatory strategy to pursue a U.S. filing. The interim analysis showed statistically...
Zenas antibody slashes MS lesions: 95% reduction reported
Zenas Biopharma reported a 95% reduction in new gadolinium‑enhancing brain lesions at 12 weeks for obexelimab versus placebo in a Phase 2 trial for relapsing multiple sclerosis. The MoonStone...
Hemab pulls in $157M to target rare coagulation disorders
Hemab Therapeutics raised $157 million in a financing round to advance a pipeline focused on underserved bleeding disorders. The funding, led by Sofinnova Partners and including Novo Holdings and...
Guardant Health, Zephyr AI partner: multimodal biomarkers in focus
Guardant Health and Zephyr AI announced a strategic partnership to combine Guardant’s multimodal molecular datasets with Zephyr’s AI analytics to accelerate discovery of genomic biomarkers for...
MIT’s BoltzGen opens AI drug design: expands the druggable universe
An MIT research team released BoltzGen, an open‑source generative model that moves from structural prediction toward generalizable therapeutic design across modalities including small molecules,...
MapLight prices $250M IPO — funding Cobenfy challenger
MapLight Therapeutics filed for and priced a $250 million IPO to develop a competitor to Bristol Myers Squibb’s schizophrenia drug Cobenfy. The proceeds will finance clinical development of the...