Manufacture
FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease Over Manufacturing Concerns
FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Concerns
FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease, Requests Additional Manufacturing Information
FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Information, Complete Response Letter
EU Calls for Cooperation and Increased Manufacturing to Overcome GLP-1 Shortage
GLP-1 receptor agonists, EU, shortages, diabetes, weight management, manufacturing, cooperation, regulatory actions
FDA Rejects Merck-Daiichi’s HER3-Targeted ADC Due to Manufacturing Issues
FDA, Merck, Daiichi Sankyo, HER3-targeted ADC, patritumab deruxtecan, manufacturing concerns, lung cancer treatment
Samsung Biologics and Baxter Expand Manufacturing Partnership with $223M Deal
Samsung Biologics, Baxter Healthcare, Manufacturing Deal, $223M, Drug Products, 2034
Johnson & Johnson Invests €580 Million in Italian Manufacturing Operations Over Five Years
Johnson & Johnson, Italy, Manufacturing, Investment, Capacity Upgrade, Research and Development, Pharmaceutical Industry
Kyowa Kirin Invests $530M in First North American Biologics Manufacturing Facility
Kyowa Kirin, biologics manufacturing, North America, investment, North Carolina
Biotech Faces a Reckoning: The Challenges and Shifts in Cell Therapies
cell therapy, biotech, gene therapy, autoimmune diseases, manufacturing challenges, market acceptance, pharmaceutical industry
Eli Lilly Invests $5.3 Billion in Indiana Plant to Boost Diabetes and Obesity Drug Production ###
Eli Lilly, Diabetes, Obesity, Mounjaro, Zepbound, Tirzepatide, Indiana, Manufacturing, API, Novo Nordisk, GLP-1 drugs
Revolutionizing CAR-Ts: The Future of Automation and Decentralization in Cell and Gene Therapy Manufacturing
Automation, Decentralization, CAR-Ts, Cell and gene therapy manufacturing, Advanced therapies, Personalized medicine, Regulatory compliance, Quality management systems, Supply chain logistics, Digital solutions, Real-time monitoring, Patient-centered care