Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Gene Therapies from Ferring, Ultragenyx in Line for Orphan Status, Moderna mRNA Drug Too
A Japanese health ministry panel on December 9 agreed to grant orphan designation for three regenerative medicine products including Ferring Pharmaceuticals’ bladder cancer gene therapy nadofaragene firadenovec, known as Adstiladrin in the US. The Pharmaceutical Affairs Council’s Committee on Regenerative…
To read the full story
Related Article
- Ferring Files for Japan Approval of Bladder Cancer Gene Therapy
September 8, 2025
REGULATORY
- DPP Calls for End to Off-Year Drug Price Cuts, Chuikyo Reform
June 15, 2026
- Pharma Wages Multi-Front Lobbying amid Push for Leaner Honebuto
June 12, 2026
- Many Approved AGs Remain Unlisted Despite Final Pre-Reform Opportunity
June 12, 2026
- iPark CEO Calls for National AI Drug Discovery Platform at LDP Hearing
June 12, 2026
- MHLW Official Urges Proper IRB Selection under New GCP Rules
June 12, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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 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…