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NanoMosaic wins FDA AMT designation for AAV QC nanoneedle
The FDA’s Center for Biologics Evaluation and Research granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle platform for multiplexed testing of AAV vector genome...
Grail seeks FDA premarket approval for Galleri multi‑cancer test
Grail submitted a premarket approval application to the FDA for its Galleri multi‑cancer early detection (MCED) blood test, citing performance and safety data from more than 25,000 patients in the...
Lilly brings manufacturing scale: $3.5B plant for retatrutide and future obesity injectables
Eli Lilly announced a $3.5 billion manufacturing facility in Lehigh Valley, Pennsylvania, to produce its next‑generation obesity injectables, including retatrutide, and related devices. The plant...
Corcept’s approval bid collides with FDA concerns: agency says warnings were raised early
Regulatory correspondence and reporting show the FDA raised substantive concerns about Corcept Therapeutics’ lead submission for a Cushing’s syndrome drug before the company filed its application....
Ultragenyx resubmits AAV gene therapy for Sanfilippo type A
Ultragenyx resubmitted an approval application to the FDA for its AAV gene therapy candidate UX111 targeting Sanfilippo syndrome type A, following a prior rejection. The company refined its...
FDA recommends MRD for accelerated approvals in multiple myeloma
The FDA issued draft guidance recommending minimal residual disease (MRD) negativity as an intermediate endpoint for accelerated approval pathways in multiple myeloma, reflecting evolving...
AstraZeneca makes $18.5bn bet on CSPC obesity drugs
AstraZeneca struck a wide-ranging collaboration with China’s CSPC Pharmaceutical Group to acquire development and commercialization rights across an eight‑program obesity and diabetes portfolio....
Lilly unveils $3.5B factory to scale next‑gen obesity injectables
Eli Lilly announced a $3.5 billion manufacturing campus in Lehigh Valley, Pennsylvania to produce retatrutide and future obesity injectables. The facility will house drug and device assembly for...
Illumina closes SomaLogic acquisition for $350M
Illumina completed its acquisition of SomaLogic and related assets from Standard BioTools for $350 million in cash, securing a CLIA/CAP lab and SomaScan proteomics capabilities. The deal brings...
Beckman Coulter, Automata link instruments to AI‑ready automation
Beckman Coulter Life Sciences and Automata announced a strategic partnership to integrate Beckman liquid‑handling and cell analysis instruments into Automata’s LINQ AI‑ready automation platform....
FDA grants AMT designation to NanoMosaic’s Nanoneedle for AAV QC
The FDA’s CBER granted an Advanced Manufacturing Technology designation to NanoMosaic’s Nanoneedle platform for multiplex testing of AAV vector genome and capsid titers. NanoMosaic said the assay...
Grail submits Galleri multi‑cancer test for FDA premarket approval
Grail filed for FDA premarket approval of its Galleri multi‑cancer early detection test, citing performance and safety data from over 25,000 patients in the Pathfinder2 study plus first‑year...
CHMP rejects Lilly’s Mounjaro for heart‑failure use; backs Novo’s semaglutide in liver disease
The European Medicines Agency’s CHMP recommended against approving Eli Lilly’s tirzepatide (Mounjaro) for a heart‑failure indication while supporting Novo Nordisk’s semaglutide for a liver disease...
Quince halts eDSP development after Phase III failure; shares collapse
Quince Therapeutics stopped development of its eDSP (dexamethasone sodium phosphate encapsulated in autologous erythrocytes) program after the phase III Neat trial in ataxia‑telangiectasia failed...
Toolbox update: Bio‑Techne, SeekGene, RAN and Reprocell launch lab products and services
Several vendors announced new products aimed at accelerating translational research and clinical workflows. Bio‑Techne launched Simple Plex Ultra‑Sensitive assays for femtogram‑level protein...
Genyro licenses Caltech Sidewinder to scale DNA writing at industrial scale
Genyro licensed Sidewinder, a DNA assembly technology from Caltech, to build complex, high‑accuracy DNA sequences at scale for synthetic biology applications. The platform published in Nature...
AstraZeneca bets on obesity: $1.2B upfront for CSPC roster
AstraZeneca struck a sweeping collaboration with China’s CSPC Pharmaceutical Group to add next‑generation weight‑loss candidates to its metabolic pipeline. The deal includes an upfront payment of...
Lilly builds capacity: $3.5B factory to make retatrutide and next‑gen injectables
Eli Lilly unveiled a $3.5 billion manufacturing facility in Lehigh Valley, Pennsylvania, dedicated to its next‑generation obesity injectables, including retatrutide. The plant will produce drug...
Illumina closes SomaLogic deal: proteomics meets NGS
Illumina completed acquisition of SomaLogic and related Sengenics assets in a cash transaction, securing proteomics capabilities and a CLIA/CAP lab in Boulder, Colorado. The deal brings...
FDA grants AMT to NanoMosaic’s nanoneedle — AAV QC technology advances
The FDA’s Center for Biologics Evaluation and Research awarded an Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle platform for multiplexed testing of AAV vector...