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
- Hisamitsu Sets April 17 Shareholders Meeting to Approve Squeeze-Out
March 16, 2026
- AbbVie Japan Files Rinvoq for Vitiligo
March 16, 2026
- SSP Appoints Yoko Motoshima as New President
March 16, 2026
- PMP Returns Slam Drug Makers' Leading Products, Prazaxa Cut 45%: Jiho Poll
March 13, 2026
- Lilly to Invest Additional 20 Billion Yen in Japan's Seishin Plant
March 13, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…