Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Kaken Files Vascular Malformation Drug in Japan, Eyes FY2027 Approval
Kaken Pharmaceutical said on May 15 that it has filed for regulatory approval in Japan for KP-001 (serabelisib), its investigational treatment for refractory vascular malformations. The application is based on data from a domestic PIII trial, with the company aiming…
To read the full story
Related Article
- Kaken’s KP-001 Hits Goal in PIII Vascular Malformation Trial
November 11, 2025
BUSINESS
- Moderna Japan Looks Beyond COVID for Next Growth Pillars
June 9, 2026
- Oncolys Targets 300 Hospitals for Telomelysin Rollout
June 9, 2026
- CSL Behring Japan President Yoshida to Step Down
June 8, 2026
- Japan Approves Oncolys’ Telomelysin for Esophageal Cancer
June 8, 2026
- Takeda Swings to Loss after Booking Amitiza Litigation Charge
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…