Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Rejects Capricor/Nippon Shinyaku’s DMD Cell Therapy, Seeking More Data
Capricor Therapeutics has hit a regulatory snag with its Duchenne muscular dystrophy (DMD) cell therapy, as the US FDA issued a complete response letter (CRL) saying the current application for deramiocel does not meet the agency’s bar for efficacy. Commercial…
To read the full story
Related Article
- FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
March 12, 2026
- PIII Win for Capricor’s DMD Cell Therapy Sets Stage for New FDA Try
December 5, 2025
- DMD Cell Therapy Accepted for FDA Review: Capricor/Nippon Shinyaku
March 6, 2025
- Nippon Shinyaku Set to Expand Capricor DMD Therapy Pact to Europe
September 19, 2024
- Nippon Shinyaku Grabs Japan Rights to Capricor’s DMD Cell Therapy
February 17, 2023
- Nippon Shinyaku Snags US Commercial Rights to Capricor’s DMD Cell Therapy
January 26, 2022
BUSINESS
- Pharma Earnings Season Kicks Off; Off-Year Impact, Overseas Trends in Focus
April 24, 2026
- Gilead Files Trodelvy-Keytruda Combo for 1L TNBC in Japan
April 24, 2026
- Co-Promotions Dominate in Oncology, Diabetes Alliances: Fuji Keizai
April 24, 2026
- Medii, Pediatric Neurology Society Build System to Support Elevidys Use
April 24, 2026
- Oncolys’ OBP-301 Wins US Fast Track Designation
April 24, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…