Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Sovaldi Has High Unmet Medical Need for Genotype 3 Hep C: MHLW Panel
A panel of experts at the Ministry of Health, Labor and Welfare (MHLW) agreed on August 3 that a high unmet medical need exists for the off-label use of Gilead Sciences’ Sovaldi (sofosbuvir) in patients with genotype 3 hepatitis C.…
To read the full story
REGULATORY
- Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
- Health Minister Signals Early March Approval for iPSC Products
February 20, 2026
- Takaichi Urges Public-Private Investment Push in Drug Discovery
February 20, 2026
- Two iPSC-Derived Products Now in Line for Conditional Approval
February 20, 2026
- PM Takaichi Keeps Cabinet Intact after Lower House Vote
February 18, 2026
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…