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Proteome‑wide AI: popEVE prioritizes rare‑disease variants for clinics
Researchers from Harvard Medical School and the Center for Genomic Regulation unveiled popEVE, a proteome‑wide deep generative model that combines evolutionary data with human population variation...
NervGen posts durable SCI gains: NVG‑291 shows functional and neurophys signals
NervGen reported expanded CONNECT SCI results showing durable functional improvements in chronic spinal cord injury patients treated with NVG‑291; improvements continued through week 16 and...
Novo’s semaglutide misses endpoints — Alzheimer’s hopes dim
Novo Nordisk reported top-line results from two Phase III trials showing oral semaglutide failed to slow clinical progression in patients with early Alzheimer’s disease. The studies enrolled...
Bayer’s oral FXIa drug cuts stroke risk — market cheers
Bayer announced that asundexian, its oral factor XIa (FXIa) inhibitor, met the primary endpoint in a large Phase III secondary prevention trial, reducing recurrent ischemic stroke without...
FDA clears Novartis’ intrathecal gene therapy — Itvisma expands SMA reach
The U.S. Food and Drug Administration approved Novartis’ Itvisma (onasemnogene abeparvovec-brve) for patients aged 2 years and older with spinal muscular atrophy (SMA) caused by biallelic SMN1...
FDA opens probe into Takeda’s Adzynma after neutralizing-antibody reports
The U.S. FDA has launched an investigation into Takeda’s Adzynma (apadamtase alfa) following postmarketing reports of neutralizing antibodies to ADAMTS13, including a pediatric death that the...
AstraZeneca to invest $2 billion in U.S. biologics capacity — jobs, onshoring push
AstraZeneca committed $2 billion to expand biologics manufacturing in Maryland, nearly doubling capacity at its Frederick site and building a new clinical-manufacturing facility in Gaithersburg....
Gilead buys TREX1 oncology program — sprinting for preclinical advantage
Gilead Sciences struck a deal to acquire a preclinical TREX1-targeted oncology program from Sprint Bioscience, committing an initial payment with up to ~$400 million in development and commercial...
Abbott to buy Exact Sciences for $23 billion — big med‑tech enters oncology testing
Abbott Laboratories agreed to acquire Exact Sciences for approximately $23 billion, a deal Abbott said will double its diagnostics addressable market by adding oncology screening,...
Cellarity’s AI flags drug‑induced liver injury — new toxicogenomics tool
Cellarity published an AI-driven toxicogenomics platform, ToxPredictor, supported by a DILImap transcriptomics library profiling 300 compounds, to predict dose-related drug-induced liver injury...
Tempus picks up OneOme pharmacogenetics assets — PGx market consolidates
Tempus acquired the pharmacogenetics assets of OneOme after the latter ceased operations, obtaining OneOme’s RightMed PGx test and related partnerships with health systems. Tempus said the deal...
Lawmakers press FDA on ultra‑fast review vouchers — transparency at issue
House Rep. Frank Pallone Jr. and Sen. Bernie Sanders sent a letter to FDA Commissioner Marty Makary expressing 'deep concerns' about the Commissioner's National Priority Voucher (CNPV) program,...
Semaglutide fails in Alzheimer’s... Two Phase III trials show no benefit
Novo Nordisk reported that two large Phase III trials testing oral semaglutide in early Alzheimer’s disease did not slow clinical decline, according to company statements and regulatory...
Novo accelerates amycretin pivots – Pivotal diabetes trials launched after Phase 2 win
Novo Nordisk is expanding development of amycretin, an amylin–GLP-1 combination, after Phase II data showed substantial reductions in body weight and blood glucose in patients with diabetes. The...
Bayer’s asundexian hits Phase III stroke goal – FXIa class revived
Bayer reported that asundexian, an oral factor XIa inhibitor, met its primary endpoint in a Phase III study, reducing recurrent ischemic stroke without increasing major bleeding, the company said...
Abbott to buy Exact Sciences: $23 billion deal reshapes diagnostics
Abbott Laboratories agreed to acquire Exact Sciences for $23 billion, combining Abbott’s diagnostics portfolio with Exact Sciences’ colorectal cancer screening, multi-cancer early detection, and...
AstraZeneca pledges $2 billion to Maryland – Biomanufacturing onshored, jobs promised
AstraZeneca announced a $2 billion investment to expand its biologics manufacturing footprint in Maryland, including a major expansion in Frederick and a new clinical-supply facility in...
Gilead buys TREX1 cancer program – $14M up front, $400M in biobucks
Gilead Sciences struck a deal to acquire a preclinical TREX1-targeting oncology program from Sprint Bioscience, paying $14 million upfront with potential milestone payments up to $400 million,...
NervGen posts durable gains in spinal cord injury – Expanded CONNECT data released
NervGen Pharma released expanded CONNECT SCI study data showing durable functional improvements in chronic spinal cord injury patients treated with NVG-291. The company reported gains that...
Lawmakers press FDA on new priority voucher scheme – Transparency, corruption flagged
Two congressional figures, Rep. Frank Pallone Jr. and Sen. Bernie Sanders, sent a letter to FDA Commissioner Marty Makary raising 'deep concerns' about the agency’s new Commissioner’s National...