AstraZeneca’s Ultomiris Gains FDA Approval for Rare Autoimmune Condition – NMOSD

AstraZeneca, Ultomiris, ravulizumab-cwvz, FDA Approval, Rare Autoimmune Disease, Neuromyelitis Optica Spectrum Disorder (NMOSD), Long-acting C5 complement inhibitor, Phase 3 CHAMPION-NMOSD Trial, Reduced Relapse Rate, Dosing Frequency

Lonza Acquires Roche’s Massive Biologics Production Facility in Vacaville, California for $1.2 Billion

Lonza, Roche, Genentech, Biologics Manufacturing Site, Vacaville/ California, $1.2 Billion Deal, Large-Scale Commercial Mammalian Products, Expansion Plans ($561 Million), Capacity Utilization, Contract Development and Manufacturing Organizations (CDMOs), Global Biologics Market Growth

FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review

Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.