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NanoMosaic wins FDA AMT—nanoneedle QC platform fast-tracked for gene therapy
NanoMosaic secured an FDA Advanced Manufacturing Technology (AMT) designation for its Nanoneedle/Tessie platform, marking regulatory recognition of a high‑throughput QC assay for AAV gene therapy...
Beckman Coulter and Automata pair up—Danaher joins Automata’s Series C
Beckman Coulter Life Sciences announced a strategic partnership with lab‑automation firm Automata to integrate liquid‑handling and genomics instruments into Automata’s LINQ automation ecosystem;...
DeepMind publishes AlphaGenome—AI models the regulatory 'dark genome'
DeepMind released AlphaGenome (also reported as Alphagenome), an AI system designed to predict the functional effects of noncoding regulatory variants across long DNA sequences. The model...
Repertoire inks $1.92B autoimmune pact with Lilly—tolerizing vaccines push forward
Repertoire Immune Medicines signed a multi‑billion‑dollar partnership with Eli Lilly to develop tolerizing therapies for autoimmune diseases, receiving an $85 million upfront payment and up to...
Grail files Galleri for FDA premarket approval—large multi-study evidence package
Grail submitted its Galleri multi‑cancer early detection test to the U.S. FDA seeking premarket approval, citing performance and safety data from more than 25,000 patients in Pathfinder 2 and...
Phase III failure collapses Quince—monthly steroid therapy for A‑T halted
Quince Therapeutics disclosed top‑line results from its pivotal Neat Phase III trial of eDSP (dexamethasone sodium phosphate encapsulated in autologous erythrocytes) for ataxia‑telangiectasia...
AstraZeneca bankrolls CSPC: up to $18.5B for next‑gen obesity drugs
AstraZeneca struck a landmark licensing and strategic collaboration with China’s CSPC Pharmaceutical Group to acquire global rights to an eight‑program obesity and type 2 diabetes portfolio. The...
FDA clears duo‑drop: Tenpoint wins approval and $235M to commercialize Yuvezzi
The U.S. Food and Drug Administration approved Tenpoint Therapeutics’ Yuvezzi, a dual‑agent ophthalmic solution (carbachol and brimonidine) for adult presbyopia, marking the first FDA‑cleared...
FDA grants AMT: NanoMosaic’s nanoneedle QC platform wins regulatory fast‑track
The FDA’s Center for Biologics Evaluation and Research granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic for its nanoneedle/Tessie platform used to multiplex genome and...
Beckman Coulter integrates with Automata — Danaher backs automation scale‑up
Beckman Coulter Life Sciences and London‑based Automata announced a strategic partnership to integrate Beckman liquid‑handling and genomic instruments into Automata’s LINQ AI‑ready automation...
Eli Lilly bets on Repertoire: $1.9B autoimmune collaboration validates Decode platform
Repertoire Immune Medicines signed a collaboration with Eli Lilly to develop tolerizing therapies for multiple autoimmune diseases. Financial terms include an $85 million upfront payment and up to...
Phase‑III fizzle topples Quince: steroid therapy fails in ataxia trial
Quince Therapeutics disclosed that its pivotal Phase III NEAT trial of dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP) in ataxia‑telangiectasia failed to meet the...
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...