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GSK and Anaptys in court — billion‑dollar royalties and rights at stake
A legal fight escalated between GSK (via Tesaro) and AnaptysBio over licensing terms tied to the cancer immunotherapy Jemperli. Tesaro filed suit alleging Anaptys breached the 2014 collaboration...
Moderna restructures: $1.5B lifeline and pipeline pruning
Moderna secured a $1.5 billion financing package as part of a plan to reach break‑even by 2028 and to redirect revenue from its seasonal vaccine franchise into oncology and rare disease. At the...
FDA ramps hiring and starts email clarifications to speed reviews
The U.S. Food and Drug Administration announced hiring more than 1,000 staffers to bolster review capacity and launched a pilot communications program letting sponsors send one 'quick...
AI accelerates early drug discovery: Iambic and AI Proteins scale up
Two AI‑driven discovery firms highlighted rapid chemistry‑to‑clinic timelines and fresh capital for protein therapeutics. Iambic reported that physics‑informed algorithms and automation have...
Abbott to buy Exact Sciences: $23 billion diagnostic push
Abbott agreed to acquire Exact Sciences in a cash deal that values the cancer-diagnostics company at roughly $21–23 billion. The transaction combines Abbott’s global diagnostics footprint with...
Bayer’s HER2 drug cleared — Thermo Fisher test approved
The FDA approved Bayer’s oral HER2-directed therapy Hyrnuo (sevabertinib) for adults with locally advanced or metastatic HER2-mutant non-small-cell lung cancer, granting the drug priority review...
Ginkgo Datapoints launches Virtual Cell Initiative... 12 billion data-point goal
Ginkgo Bioworks’ Datapoints unit unveiled the Virtual Cell Pharmacology Initiative (VCPI), an open-source effort to build a standardized pharmacology dataset and reference engineered cell line...
Ocean Diagnostics’ rapid sepsis test matches culture results 100%
France-based Ocean Diagnostics completed a pilot clinical evaluation showing its rapid bloodstream pathogen identification test matched gold‑standard blood cultures at 100% in a prospective ICU...
Novartis to build flagship US manufacturing hub — North Carolina expansion
Novartis announced plans to construct a flagship manufacturing hub in North Carolina as part of a $23 billion U.S. infrastructure investment over five years. The project will add biologics...
Industry pushes for FDA stability as Makary aide stays amid White House fracas
Hundreds of biotech CEOs delivered a letter to FDA Director Marty Makary warning that regulatory unpredictability threatens innovation; the group cited survey evidence that 82% of respondents were...
Contineum’s PIPE‑307 misses Phase II vision endpoints — shares tumble
Contineum Therapeutics reported topline results from its Phase II VISTA trial of PIPE‑307, an M1 receptor antagonist developed with Janssen, and the study failed to meet its primary and secondary...
Hepta publishes cfDNA methylation proof‑of‑concept for liver disease
Hepta released proof‑of‑concept data indicating cell‑free DNA methylation signatures in plasma reflect liver biology, including fibrosis and cell‑type composition, based on an atlas assembled with...
Cassidy Bio raises $8M seed to scale AI platform for gene‑editing design
Tel Aviv‑based Cassidy Bio closed an $8 million seed round led by Ahren Innovation Capital to develop an AI platform that predicts optimal combinations of guide RNAs, editing enzymes and delivery...
Aspen closes $115M Series C to advance personalized Parkinson’s cell therapy
Aspen Neuroscience secured $115 million in Series C financing to support its autologous cell therapy program for Parkinson’s disease, expand manufacturing capacity and progress an ongoing clinical...
Abbott to buy Exact Sciences: $105-a-share deal reshapes cancer-diagnostics market
Abbott announced a definitive agreement to acquire Exact Sciences for $105 per share, a transaction valued at roughly $21 billion in equity and about $23 billion on an enterprise basis in some...
FDA clears Bayer’s Hyrnuo: new HER2 therapy and companion test land
The U.S. Food and Drug Administration approved Bayer’s oral HER2‑directed drug Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non‑squamous NSCLC harboring activating HER2...
Pfizer’s mRNA flu shot... Phase 3 shows 34.5% efficacy advantage
Pfizer released full Phase 3 data showing its experimental mRNA influenza vaccine candidate delivered a 34.5% greater protective efficacy than a standard control vaccine in the trial cohort. The...
Novartis builds flagship US hub: North Carolina chosen for end‑to‑end manufacturing
Novartis announced plans to build a flagship manufacturing hub across its North Carolina sites, adding new biologics, sterile packaging and solid‑dose facilities in Durham and Morrisville. The...
FDA hires 1,000+ and pilots email clarifications to speed drug reviews
The FDA announced plans to add more than 1,000 staffers and launched a pilot communications program that allows sponsors to submit one brief email clarification to Office of New Drugs review staff...
Lilly hits $1 trillion: obesity drugs drive pharma’s first trillion‑dollar market cap
Eli Lilly briefly became the first pharmaceutical company to reach a $1 trillion market capitalization, a milestone driven by blockbuster growth in its obesity and diabetes portfolio. The intraday...