European Medicines Agency– tag –
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Global Summits Confront Cell & Gene Therapy Scale-Up: Automation, Cost Efficiency, and Mass Production Strategies
Informa Connect International Overview Upcoming international conferences, including Advanced Therapies Europe and the CAR-TCR Summit in September 2026, are set to address the urgent need for scalable and cost-effective manufacturing in ... -
Exosome-Based Therapeutics Development Summit Convenes in Boston to Address Manufacturing, Regulatory, and Clinical Challenges
Hanson Wade Conferences USA Overview The 8th Exosome-Based Therapeutics Development Summit will be held in Boston from September 22-24, 2026, focusing on overcoming challenges in scalable manufacturing, robust analytical characterization... -
AI-Guided 3D Bioreactors Revolutionize iPSC Manufacturing: Scaling Up and Cutting Costs for Accelerated Commercialization
Wiley Analytical Science USA Overview AI-guided 3D bioreactor technology is revolutionizing iPSC manufacturing, enabling reliable, efficient, and scalable production of pluripotent stem cells (PSCs). This innovative platform facilitates ... -
REPROCELL Pioneers Integrated iPSC Manufacturing Platform, Accelerating US Phase III Clinical Programs with AI-Enhanced Gene Editing and GMP Compliance
REPROCELL Japan Overview REPROCELL has launched a comprehensive iPSC manufacturing platform designed to accelerate the clinical development of iPSC-derived therapeutics, notably supporting a US Phase III program. The platform integrates ... -
Breakthrough: EU Approves Oral BTK Inhibitor Tolebrutinib as First Disability-Targeting Therapy for Nonrelapsing SPMS
NeurologyLive Europe Overview The European Commission has approved Sanofi's oral, brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib (Cenrifki), for nonrelapsing secondary progressive multiple sclerosis (SPMS). This a... -
EMA Panel Backs Incyte’s Opzelura: Topical JAK Inhibitor Promises Rapid Relief for Moderate Atopic Dermatitis
Medical Update Online Europe Overview The European Medicines Agency's (EMA) CHMP has issued a positive opinion for Incyte's Opzelura (ruxolitinib) cream, recommending its approval for adult patients with moderate atopic dermatitis unresp... -
SynaptixBio Accelerates Regulatory Pathway for Ultra-Rare ASO Drugs, Expanding Therapeutic Potential of TUBB4A Mutant Silencers
Advancing RNA USA Overview SynaptixBio is effectively navigating the regulatory landscape for ultra-rare antisense oligonucleotide (ASO) drugs, securing Orphan Drug and Rare Pediatric Disease designations in collaboration with the FDA, E... -
Building Commercial Readiness in Advanced Therapies: Optimizing Supply Chain, Manufacturing, and Regulatory Strategy is Critical
The Medicine Maker Unknown Overview Achieving commercial readiness for Advanced Therapy Medicinal Products (ATMPs), particularly cell and gene therapy products, is an urgent industry imperative. This requires establishing robust supply c... -
CDMO Capacity Crunch Persists in Cell and Gene Therapy Sector: Strategic Partnerships Crucial for Accelerating Innovation
Contract Pharma USA Overview The cell and gene therapy (CGT) sector faces a severe and persistent capacity crunch among Contract Development and Manufacturing Organizations (CDMOs), driven by soaring demand. This bottleneck significantly... -
AGC Biologics Commits Half of New Yokohama Biomanufacturing Plant to Major Long-Term Deal
Megaproject Japan Overview AGC Biologics has secured a significant multi-million dollar, long-term commercial manufacturing contract with an undisclosed pharmaceutical firm for its new Yokohama facility, set to open in 2027. This landmar...
