Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Chugai’s DMD Gene Therapy Now in Line for Conditional Approval
Chugai Pharmaceutical’s gene therapy for Duchenne muscular dystrophy (DMD) cleared the review of a key health ministry panel on April 18, opening the way for its conditional, time-limited approval. The product, delandistrogene moxeparvovec, gained the blessing of the Pharmaceutical Affairs…
To read the full story
Related Article
- Chugai’s DMD Gene Therapy Snags Conditional Approval in Japan
May 14, 2025
- J-TEC’s JACC Widens Label into Knee Osteoarthritis
May 14, 2025
- Chugai Files DMD Gene Therapy Elevidys in Japan
August 19, 2024
- J-TEC Files JACC for Label Expansion into Knee Osteoarthritis
June 19, 2024
REGULATORY
- MHLW to Allow OTC Drugs to Match Prescription Doses under Specific Conditions
February 5, 2026
- Japan Launches Biotechnology Working Group, Roadmap Draft Due in April
February 4, 2026
- Japan Panel Backs Nonprescription Switch of Second Emergency Contraceptive
February 4, 2026
- MHLW Set to Launch Searchable Drug Supply Database in April
February 3, 2026
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…