July 2025
Atai’s Schizophrenia Drug Fails to Improve Cognition in Phase 2 Study
Atai Life Sciences; Recognify Life Sciences; inidascamine; schizophrenia; cognitive impairment; Phase 2b trial; clinical trial failure; cognition; CIAS; clinical endpoints
Rethinking Clinical Trial Data in the Era of Decentralization: Key Trends and Challenges (2025)
decentralized clinical trials; DCT; data quality; patient diversity; remote monitoring; AI in trials; data integration; risk-based oversight; clinical trial data; regulatory guidance
Roche Doubles Down on Alzheimer’s with Next-Gen Amyloid-Lowering Drug Trontinemab
Roche; Alzheimer’s disease; trontinemab; amyloid-lowering drug; Brainshuttle; Phase III trial; TRONTIER studies; drug development; biomarkers; early intervention
CHMP Recommends Against Approval of Elevidys Gene Therapy in Europe, Dealing Blow to Sarepta and Roche
CHMP; Elevidys; Sarepta; Roche; gene therapy; Duchenne muscular dystrophy; EMA; negative opinion; Europe; EMBARK trial
Trinity Biotech Repositions for AI-Driven Growth with CGM+ Biosensor Platform
Trinity Biotech; CGM+; AI-powered healthcare; digital health; continuous glucose monitor; wearable biosensor; multi-sensor data; predictive analytics; personalized medicine; chronic disease management
FDA Official Says Sarepta Faces Major Hurdles to Reintroduce DMD Therapy Elevidys
Sarepta; Elevidys; FDA; Duchenne muscular dystrophy; gene therapy; CBER; safety concerns; shipment pause; new studies; approval status
Galapagos Considers Sale of Cell Therapy Unit in Ongoing Strategic Overhaul
Galapagos; cell therapy; sale; strategic alternatives; pipeline pruning; biotech; spinout; Gilead Sciences; GLPG5101; mantle cell lymphoma; business development
Rocket Pharmaceuticals Cuts 30% of Staff, Refocuses on Heart Gene Therapies
Rocket Pharmaceuticals; layoffs; restructuring; 30% workforce reduction; cardiovascular gene therapy; adeno-associated virus (AAV); Danon disease; PKP2-associated cardiomyopathy; BAG3-associated dilated cardiomyopathy; operating cost reduction; Fanconi Anemia; Pyruvate Kinase Deficiency; KRESLADI
Novartis Bets on Covalent Chemistry in $1B Matchpoint Therapeutics Deal
Novartis; Matchpoint Therapeutics; covalent chemistry; exclusive option and license agreement; inflammatory diseases; oral inhibitors; Advanced Covalent Exploration platform; drug development; biotechnology partnerships
AstraZeneca’s Self-Administered Myasthenia Gravis Drug Gefurulimab Clears Phase 3 Trial
AstraZeneca; gefurulimab; myasthenia gravis; self-administered drug; Phase 3 trial; PREVAIL trial; C5 inhibitor; autoimmune disease; clinical trial; Alexion acquisition