Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Astellas’ Izervay, Otsuka’s Nexletol among New Drugs Up for Japan Panel Review; Eylea Biosimilars Also on Agenda
Japan’s health ministry will convene the Pharmaceutical Affairs Council’s First Committee on Drugs on August 29 to review a slate of applications, including six new molecular entities (NMEs) — some positioned as next-generation growth drivers for major firms. The agenda…
To read the full story
Related Article
- Japan Panel Clears Izervay, Nexletol for Approval; Eylea Biosimilars Edge Ahead Too
September 1, 2025
- Maruishi Files Midazolam Oral Syrup for Pediatric Use
March 7, 2025
- Higher-Dose Regimen of Spinraza Filed in Japan: Biogen
March 3, 2025
- Izervay Filed for Conditional Approval in Japan: Astellas
February 6, 2025
- J&J Files Nipocalimab for Generalized Myasthenia Gravis in Japan
January 31, 2025
- Pfizer Files Migraine Drug Rimegepant in Japan
November 28, 2024
- Otsuka Files Esperion’s Cholesterol Fighter in Japan
November 27, 2024
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
June 8, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…