Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA Reviewing New Safety Risks for Soliris, Venclexta/Noxafil
The Pharmaceuticals and Medical Devices Agency (PMDA) is investigating new side effect risks for Alexion Pharmaceuticals’ C5 complement inhibitor Soliris (eculizumab), a move likely to trigger label changes in the near future. According to the agency’s risk communication update on…
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REGULATORY
- MHLW Panel Calls for Careful Design of OTC-Like Drug Charge System
March 23, 2026
- Japan Hands Out Orphan Tags to Ianalumab, Bleximenib, and Lots More Drugs
March 23, 2026
- Ex-LDP Lawmaker, Pharmacist Jun Matsumoto Dies at 75
March 23, 2026
- LDP Project Team Flags Drug Pricing as Key to Investment
March 19, 2026
- Japan Sets Up Radiopharma Discovery Hub in Fukushima, Targets Rare Cancers
March 18, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…