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EMA probes Amgen’s Tavneos — Amgen pares down immunology program
The European Medicines Agency opened a review of Amgen’s vasculitis drug Tavneos (avacopan) after receiving new information that raised questions about data integrity in the ADVOCATE study...
Lecanemab ARIA linked to CD8 expansion — immune mechanism surfaces
A new study in Nature Communications reports clonal expansion of cytotoxic CD8+ T cells in association with ARIA (amyloid‑related imaging abnormalities) observed in patients treated with...
Grail files Galleri for FDA PMA — multi‑cancer blood test moves toward market
Grail submitted a premarket approval (PMA) application to the U.S. FDA for its multi‑cancer early detection test Galleri, citing performance and safety data from over 25,000 patients in the...
DeepMind publishes AlphaGenome — AI decodes noncoding variant effects
DeepMind released AlphaGenome, a large DNA‑sequence model reported in Nature that predicts regulatory effects of noncoding variants across up to one million base pairs. The model outputs thousands...
AstraZeneca bets $18.5bn: China tie brings next‑gen weight‑loss shots
AstraZeneca struck a transformative strategic collaboration with China’s CSPC Pharmaceuticals, paying $1.2 billion up front and structuring the deal to reach roughly $18.5 billion in total...
FDA designates NanoMosaic’s nanoneedle — gene therapy QC cleared for priority engagement
The FDA’s Center for Biologics Evaluation and Research (CBER) granted an Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s nanoneedle/Tessie multiplex QC platform, recognizing it...
TrumpRx launch postponed... compliance and anti‑kickback questions stall rollout
The White House delayed the public launch of TrumpRx, the administration’s direct‑to‑consumer drug marketplace, after administration officials and outside counsel flagged potential anti‑kickback...
Amgen jilts Kyowa Kirin — high‑stakes immunology asset returns after program exit
Amgen terminated its collaboration with Kyowa Kirin on an anti‑OX40 autoimmune candidate, returning rights to Kyowa Kirin despite Amgen having run extensive pivotal programs and achieved Phase 3...
Quince’s Phase 3 miss: steroid program fails, company halts development
Quince Therapeutics announced its once‑monthly steroid‑based therapy failed a Phase 3 trial in ataxia‑telangiectasia, a rare genetic disorder, and said it will stop development of the experimental...
Illumina closes SomaLogic deal: $350m buy expands proteomics and CLIA lab reach
Illumina completed its acquisition of SomaLogic and related assets from Standard BioTools for $350 million in cash, plus potential near‑term milestone payments and royalties. The deal brings...
Lilly ramps capacity: $3.5B Lehigh Valley plant to make retatrutide and injectables
Eli Lilly announced a $3.5 billion investment to build a new manufacturing campus in Lehigh Valley, Pennsylvania, dedicated to next‑generation obesity injectables and associated devices, including...
FDA draft: MRD recommended for accelerated multiple myeloma approvals
The FDA issued draft guidance updating preferred endpoints for multiple myeloma drug development, advocating minimal residual disease (MRD) negativity as an intermediate endpoint for accelerated...
Grail files Galleri for FDA premarket approval — large study evidence included
Grail submitted a PMA application to the FDA seeking premarket approval for its multi‑cancer early detection blood test Galleri, citing performance and safety data from more than 25,000 patients...
Tenpoint wins FDA approval — presbyopia duo‑drop cleared with $235M financing
Tenpoint Therapeutics secured FDA approval for Yuvezzi, a dual‑agent eye drop (carbachol and brimonidine) for adult presbyopia, becoming the first dual‑mechanism topical treatment cleared in the...
AstraZeneca bets $18.5bn on CSPC weight‑loss drugs: $1.2bn upfront
AstraZeneca struck a landmark agreement to secure global rights to eight long‑acting, one‑month injectable weight‑loss candidates from China’s CSPC, committing up to $18.5 billion in deal value....
AstraZeneca in China... venture bets and dealmaking to fuel $15bn plan
AstraZeneca outlined a $15 billion investment program for China through 2030, announcing capital deployment across manufacturing, R&D and partnership activity to expand local capabilities. Company...
FDA grants NanoMosaic AMT designation – gene‑therapy QC gets regulatory nod
The FDA’s Center for Biologics Evaluation and Research awarded NanoMosaic an Advanced Manufacturing Technology (AMT) designation for its Nanoneedle/Tessie platform, which performs multiplexed...
Repertoire adds Lilly to partnership roster – autoimmune pact tops $2.6bn
Repertoire Immune Medicines expanded its Big‑Pharma partnerships by signing an alliance with Eli Lilly to develop tolerizing therapies for autoimmune diseases. Financial terms reported include an...
Tenpoint wins FDA clearance for combo presbyopia drop – financing follows
Tenpoint Therapeutics received U.S. FDA approval for Yuvezzi, the first dual‑agent ophthalmic drop for presbyopia combining carbachol and brimonidine. The company concurrently closed financing...
FDA suspends Regenxbio gene‑therapy trials after tumor finding – regulator steps in
U.S. regulators put Regenxbio’s clinical programs on hold after detection of a central nervous system neoplasm in a pediatric participant, prompting an FDA clinical hold across at least two...