Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
FDA Resumes Review of Capricor/Nippon Shinyaku’s DMD Cell Therapy
The US FDA has resumed its review of Capricor Therapeutics’ Duchenne muscular dystrophy (DMD) cell therapy deramiocel, also known as CAP-1002, the biotech said on March 10. The agency has set a new target action date of August 22. The…
To read the full story
Related Article
- PIII Win for Capricor’s DMD Cell Therapy Sets Stage for New FDA Try
December 5, 2025
- FDA Rejects Capricor/Nippon Shinyaku’s DMD Cell Therapy, Seeking More Data
July 15, 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
- Astellas’ Protein Degrader Setidegrasib Enters PIII in US
April 1, 2026
- Pfizer Hails Adult Rollout of Prevenar 20 as “Milestone” for Public Health
April 1, 2026
- Kyorin Exercises Option for BIODOL’s Pain Drug Candidate
April 1, 2026
- UCB Japan Files Zilbrysq Autoinjector in Japan
April 1, 2026
- Tanabe Unveils PIII Data for EPP/XLP Therapy, Backing Filing Plans
March 31, 2026
Strategic Talent Acquisition in the Japanese Life Sciences Sector: Your Market Intelligence Briefing
Focus: How to Get the Talent You Need in a Tough MarketThe Japanese life sciences sector presents a challenging landscape for global companies. To succeed, you must move beyond reactive hiring and adopt a truly strategic talent acquisition model. Our…
Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…
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…