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Grail files Galleri for FDA PMA: large clinical dataset submitted
Grail submitted its Galleri multi‑cancer early detection test to the FDA for premarket approval, citing performance and safety data from more than 25,000 patients drawn from the Pathfinder 2 study...
Beckman pairs with Automata — Danaher backs automation scale
Beckman Coulter Life Sciences announced a strategic partnership to integrate its liquid‑handling and cell‑analysis instruments with Automata’s LINQ AI‑ready automation platform, aiming to deliver...
Ultragenyx resubmits UX111: gene therapy for Sanfilippo A refiled
Ultragenyx Pharmaceuticals resubmitted an application to the FDA seeking approval for UX111, an AAV‑based gene therapy for Sanfilippo syndrome type A, following an earlier rejection last summer....
Repertoire signs Lilly pact: $85m upfront, $1.84bn in milestones
Repertoire Immune Medicines signed a collaboration with Eli Lilly to develop tolerizing therapies for several autoimmune indications. The agreement provides an $85 million upfront payment and...
AstraZeneca bets $18.5bn on CSPC obesity lineup
AstraZeneca moved decisively to bulk up its obesity and metabolic pipeline by striking a wide-ranging partnership with China’s CSPC Pharmaceutical Group and committing major investments in the...
Beckman Coulter partners Automata: scale AI‑ready lab automation
Beckman Coulter Life Sciences announced a strategic partnership with London automation firm Automata to integrate liquid‑handling and cell analysis instruments into Automata’s LINQ AI‑ready...
NanoMosaic earns FDA AMT designation – speeds AAV QC
The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle/Tessie platform, recognizing the technology as a regulatory‑relevant approach for multiplexed quality...
Illumina completes SomaLogic acquisition to expand proteomics
Illumina closed its acquisition of SomaLogic and related assets from Standard BioTools, paying $350 million in cash plus up to $75 million in near‑term milestones and royalties. The deal brings...
Repertoire lands Lilly’s $1.9bn autoimmune pact
Repertoire Immune Medicines signed a high‑value partnership with Eli Lilly to develop tolerizing therapies for multiple autoimmune diseases. The deal includes an $85 million upfront payment, up to...
Phase III fizzle... Quince collapses
Quince Therapeutics announced top‑line results from its pivotal Phase III Neat trial testing monthly dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP) for...
FDA drafts myeloma guidance: MRD favored for accelerated approvals
The FDA issued draft guidance advising sponsors developing multiple myeloma therapies to use minimal residual disease (MRD) negativity as a key endpoint for accelerated approval pathways. The...
Grail submits Galleri multi‑cancer test to FDA for PMA
Grail filed a premarket approval (PMA) submission for its Galleri multi‑cancer early detection test, centering the dossier on performance and safety data from more than 25,000 participants in...
DeepMind launches AlphaGenome: predicts regulatory variant effects
Google DeepMind published AlphaGenome, a sequence‑based model that predicts regulatory effects of non‑coding genomic variants across long DNA contexts up to one million base pairs. The model...
Corcept says FDA warned it — regulatory dispute surfaces
Two reports surfaced about Corcept Therapeutics’ failed submission for a Cushing’s syndrome drug: the company received a complete response letter, and the FDA stated the agency had flagged serious...
AstraZeneca bets on China: $15bn push and $1.2bn CSPC obesity pact
AstraZeneca expanded its China play with two coordinated moves: a broad investment commitment and a targeted licensing pact. The company agreed a strategic collaboration with CSPC that pays $1.2...
Illumina closes SomaLogic buy: proteomics scales inside NGS ecosystem
Illumina completed its acquisition of SomaLogic and related assets, paying $350 million in cash plus contingent milestones and royalties. The transaction brings SomaLogic’s SomaScan aptamer‑based...
NanoMosaic wins FDA AMT nod: gene therapy QC tech prioritized
The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Nanoneedle platform for multiplex testing of AAV vector genome and capsid titers. The designation gives...
Tenpoint’s presbyopia win: FDA clears dual‑agent drop and backstops launch with $235M
Tenpoint Therapeutics secured FDA approval for Yuvezzi, the first dual‑agent ophthalmic drop for presbyopia combining carbachol and brimonidine. The clearance positions Tenpoint against...
Phase‑III miss implodes Quince: steroid therapy for A‑T abandoned
Quince Therapeutics halted development of its lead eDSP (dexamethasone encapsulated in autologous erythrocytes) program after its pivotal NEAT Phase III in ataxia‑telangiectasia failed to meet...
Lilly taps Repertoire: $1.92bn alliance to decode and treat autoimmunity
Eli Lilly struck a deal with Repertoire Immune Medicines to develop tolerizing therapies for autoimmune diseases, a collaboration structured with an $85 million upfront payment and up to $1.84...