Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Medipal/JCR’s MPS IIIB Therapy Snags Orphan Tag in US
Medipal Holdings and JCR Pharmaceuticals said on May 7 that the US FDA has granted orphan drug designation for JR-446, an investigational drug for mucopolysaccharidosis type IIIB (MPS IIIB), a lysosome disease also known as Sanfilippo syndrome type B.JR-446 is…
To read the full story
Related Article
BUSINESS
- Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
March 6, 2026
- Japan Grants First-Ever Approval to iPSC-Based Therapies
March 6, 2026
- Meiji Starts Japan PIII Trial of Rezurock for CLAD
March 6, 2026
- Meiji Rolls Out Rezurock in Taiwan
March 6, 2026
- Toray Out-Licenses Parkinson’s Drug to Immunis
March 6, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…