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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The FDA issued draft guidance updating preferred endpoints for multiple myeloma drug development, advocating minimal residual disease (MRD) negativity as an intermediate endpoint for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...
CMS names drugs for Round‑Three negotiation: Part B biologics included
The U.S. Centers for Medicare & Medicaid Services published the 15 drugs selected for the third round of Medicare drug‑price negotiations, marking the first time Part B physician‑administered...
Eikon pushes public markets: dual IPO filings point to large raise for oncology push
Eikon Therapeutics advanced IPO plans with public filings indicating a multi‑hundred‑million dollar raise to fund its oncology‑focused pipeline anchored by Chinese cancer assets. The company set...
Moderna spins out late‑stage rare disease asset to Recordati: $50m upfront
Moderna out‑licensed a late‑stage rare‑disease candidate to Recordati in a deal that included $50 million up‑front consideration, shifting registrational‑stage development to the buyer. The...
Amgen walks away from Kyowa $400m autoimmune pact – program halted
Amgen terminated its collaboration with Kyowa Kirin on the anti‑OX40 antibody rocatinlimab, exiting a program for which it had previously paid $400 million in rights. Industry reports indicate...
FDA halts Regenxbio gene trials: tumor triggers safety pause
The FDA placed Regenxbio’s early-stage gene therapy trials on clinical hold after a treated pediatric patient was diagnosed with a central nervous system tumor. The regulator suspended studies of...
FDA grants AMT to NanoMosaic: gene therapy QC gets priority access
The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Tessie platform, a nanoneedle-based QC system for AAV gene therapies. The designation enables enhanced agency...
AstraZeneca doubles down on China: $15B plan and regional deals
AstraZeneca unveiled a long-term China strategy backed by a planned $15 billion investment to expand R&D and manufacturing across the value chain through 2030. The investment aims to scale cell...
Repertoire expands Big‑Pharma footprint: Lilly deal tops prior partnerships
Repertoire Immune Medicines added Eli Lilly to its roster of pharma partners in a multimarket tolerizing‑therapy collaboration, securing a major upfront and milestone package that values the...