European Medicines Agency– tag –
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Catalent Bolsters End-to-End CDMO Services for Autologous & Allogeneic Cell Therapies, Including iPSC Center of Excellence
Catalent USA Overview Catalent is enhancing its end-to-end CDMO manufacturing support and process development services for both autologous and allogeneic cell therapies, covering CAR-T, TCR, TIL, NK cells, and iPSC- and MSC-derived treat... -
AGC Biologics Secures Landmark Multi-Hundred-Million-Dollar Deal for Yokohama Facility, Cementing Japan’s Biologics Manufacturing Leadership
AGC Biologics Japan Overview AGC Biologics has secured a multi-year, multi-hundred-million-dollar commercial manufacturing agreement for its new Yokohama facility, slated to open in 2027. This landmark deal dedicates approximately half o... -
Reusable Bioreactor Market Surges: Driven by Large-Volume Biologics Production and CDMO Capacity Expansion, Hybrid Manufacturing Emerges
Constancy Researchers USA Overview The reusable bioreactor market is experiencing substantial growth, propelled by the increasing demand for large-volume commercial biopharmaceutical production and the expansion of CDMO capacities. A not... -
Perfusion Bioreactor Market Surges Driven by Continuous Biomanufacturing and Intensified Bioprocessing; Thermo Fisher’s DynaDrive Platform Leads
Constancy Researchers USA Overview The perfusion bioreactor market is experiencing rapid growth, primarily fueled by the adoption of continuous biomanufacturing and intensified bioprocessing strategies. Thermo Fisher Scientific's HyPerfo... -
EMA Recommends Approval for New Hypercholesterolemia Drug Evlarco (Obicetrapib / Ezetimibe): A Combination of CETP Inhibitor and Cholesterol Absorption Inhibitor
EMA EU Overview On July 23, 2026, the EMA's CHMP adopted a positive opinion recommending marketing authorization for Evlarco (obicetrapib / ezetimibe). This oral medication is for the treatment of primary hypercholesterolemia or mixed dy... -
Ribo Life Science’s siRNA Therapy Vortosiran Receives EMA Approval for Stroke Prevention Trial in Atrial Fibrillation Patients
Insight, China's Pharmaceutical Industry China Overview Ribo Life Science's siRNA therapy, vortosiran (BD4059), has received clinical trial approval from the EMA for stroke prevention in atrial fibrillation (SPAF) patients. Vortosiran is... -
Daiichi Sankyo & AstraZeneca’s Enhertu Plus Pertuzumab Recommended for EU Approval as 1st-Line Treatment for HER2-Positive Metastatic Breast Cancer, Achieves 44% Risk Reduction in Phase III
Daiichi Sankyo Press Release Japan Overview The EMA's CHMP has recommended Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for approval as a first-line treatment for HER2-positive metastatic breast cancer in the EU. This ... -
EMA CHMP Recommends 12 Medicines for Approval, Including 3 New Hypercholesterolemia Drugs and Therapies for Cholestatic Pruritus and Cerebral Adrenoleukodystrophy
EMA EU Overview The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for twelve medicines at its July 2026 meeting. This includes three new medicines for hypercholesterolemia or mixed dyslipidemia: Ly... -
FDA Flexibilizes Cell and Gene Therapy CMC Regulations, Eliminating ‘Rule of Three’ to Accelerate Development
BioProcess International USA Overview The U.S. FDA has announced a flexible Chemistry, Manufacturing, and Controls (CMC) guidance for Cell and Gene Therapy (CGT) products, effectively ending the traditional 'Rule of Three' validation req... -
AI and Digital Twin Challenges in GMP Manufacturing: Regulators Demand Audit Trails for Continuously Learning Models
BioPharma APAC Singapore Overview AI and digital twin technologies promise breakthroughs in GMP biomanufacturing, enabling predictive maintenance, real-time release, and high yields. However, regulatory challenges concerning the validati...
