ORG
Biotech Leaders Urge FDA to ‘Modernise’ Regulation to Compete with China
FDA; biotech; regulation; modernization; China; cell and gene therapy; CEO roundtable; competitiveness; innovation
23andMe to Restart Auction After Former CEO Anne Wojcicki Outbids Regeneron
23andMe; auction; Anne Wojcicki; Regeneron; TTAM Research Institute; bankruptcy; asset sale; genetics
Corcept Highlights Survival Benefit Despite ALS Trial’s Missed Primary Endpoint
Corcept Therapeutics; dazucorilant; ALS; amyotrophic lateral sclerosis; DAZALS trial; survival benefit; phase 2 study; ALSFRS-R; ENCALS 2025
Schott Pharma Invests Over €100M in New Sterile Cartridge Facility at Hungary Site
Schott Pharma; Hungary; sterile cartridge facility; €100 million investment; RTU cartridges; pharma packaging; manufacturing expansion; Lukácsháza; GLP-1 drugs; diabetes; automation; environmental impact
Cullinan Inks $700M Deal for BCMA Bispecific to Expand Autoimmune T-Cell Engager Portfolio
Cullinan Therapeutics; Genrix Bio; BCMA bispecific; velinotamig; T-cell engager; autoimmune disease; CD19xCD3; CLN-978; multiple myeloma; clinical development; biotech partnerships
Forging the Future of Cell Therapy: Bayer and BlueRock’s Unique Journey
cell therapy; Bayer; BlueRock Therapeutics; Parkinson’s disease; bemdaneprocel; biotech partnerships; RMAT designation; Phase 3 trials; regenerative medicine
Vigil’s Iluzanebart Fails Phase 2 in Rare Neuro Disease; Sanofi Takeover Remains On Track
Vigil Neuroscience; iluzanebart; Phase II IGNITE trial; rare neuro disease; ALSP; Sanofi acquisition; Amgen; TREM2 agonist; VG-3927
Sarepta’s rAAVrh74 Viral Vector Receives FDA Platform Technology Designation for Gene Therapy
Sarepta Therapeutics; FDA; platform technology designation; rAAVrh74 viral vector; gene therapy; SRP-9003; limb-girdle muscular dystrophy; rare diseases
Eli Lilly and Camurus Sign $870M Deal for Long-Acting Obesity Therapies
Eli Lilly; Camurus; obesity drugs; long-acting therapies; FluidCrystal technology; incretin drugs; cardiometabolic health; pharma partnerships; drug development; biotech collaboration
FDA Approves Moderna’s Next-Generation Covid Vaccine With Limited Use for Most Healthy People
Moderna; FDA approval; mNexspike; next-generation Covid vaccine; vaccine restrictions; Covid-19; Spikevax; elderly; high-risk medical conditions; Omicron JN.1 variant