PMDA– tag –
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Commercial-Scale iPSC Cell Therapy: Advancements in Off-the-Shelf Treatments, Immunogenicity, and Cost Reduction are Key
The Medicine Maker UK Overview This article examines the challenges and technological advances in scaling induced pluripotent stem cell (iPSC) platforms for commercial cell therapies. It highlights the shift towards allogeneic, off-the-s... -
City of Hope Reports Groundbreaking Phase 1 Data for CD19 CAR T-Cell Therapy in High-Risk ALL Patients, Achieving 84% 18-Month Event-Free Survival with Low Toxicity
Evaluate (Oncology Newsletter) USA Overview Researchers at City of Hope presented pivotal Phase 1 data for a CD19 CAR T-cell therapy in acute lymphoblastic leukemia (ALL), demonstrating an impressive 84% 18-month event-free survival rate... -
IPS HEART’s iPSC-Derived Cell Therapy ISX9-CPC Receives FDA Rare Pediatric Disease Designation for Muscular Dystrophy-Associated Cardiomyopathy
StreetInsider USA Overview IPS HEART, Inc. announced that its iPSC-derived cell replacement therapy, ISX9-CPC, has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for cardiomyopathy associated with muscular dystrophi... -
Pharmaceuticals and Medical Devices Agency (PMDA) Updates Regenerative Medicine Product Approval List and Advances International Regulatory Harmonization
Pharmaceuticals and Medical Devices Agency (PMDA) Japan Overview On August 5, 2026, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) updated its approval list for regenerative medicine products, covering April 2015 to May 2026. ... -
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... -
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... -
Understanding Regenerative Medicine: Distinguishing PMDA-Approved Treatments from Research in Japan
GINZA YR CLINIC Japan Overview Regenerative medicine, encompassing cell therapies, stem cell research, and tissue engineering, aims to restore damaged tissues and organs. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is... -
Biologics Outsourcing Redefined: Modality Expertise & End-to-End Integration Key for Partnerships
Bioprocess Online USA Overview Biologics manufacturing outsourcing is evolving into strategic partnerships focused on modality expertise, regulatory excellence, and end-to-end integration, moving beyond mere cost savings. To support incr... -
Data Integrity in Bioprocessing: ALCOA+ Compliance Critical for Ensuring Reliability of GMP Records
Lab Manager Global Overview In bioprocessing labs, data integrity and adherence to ALCOA+ principles are critical for meeting regulatory expectations and ensuring product safety and efficacy. All GMP records, including those from bioreac... -
REPROCELL Submits Application for Manufacturing and Marketing Approval in Japan for Stemchymal® Stem Cell Therapy for Spinocerebellar Ataxia (SCA3 and SCA6)
BioSpace Japan Overview REPROCELL Inc. has submitted an application for manufacturing and marketing approval in Japan for its regenerative medicine product, Stemchymal®, aimed at inhibiting the progression of motor ataxia in patients wit...
