Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Govt Giving Advice to Fujifilm after Shelving Decision on Avigan
The Japanese government is giving Fujifilm Toyama Chemical a full explanation on the rationale of its decision to withhold approval for its antiviral Avigan (favipiravir) for the treatment of COVID-19 and offering related advice. The government revealed this in a…
To read the full story
Related Article
- Avigan Used Improperly for 429 Patients in Observational Study: MHLW
February 21, 2023
- Japan Govt to End Observational Avigan Study for COVID-19
January 5, 2022
- 10,000 COVID-19 Patients Received Avigan in Observational Studies: Govt
February 25, 2021
- Advisory Panel Shelves Decision on Avigan, Says No Clear Efficacy Shown for COVID-19
December 22, 2020
REGULATORY
- Panel Clears Zolgensma Intrathecal Form to Expand Use in Older SMA Patients
March 10, 2026
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
- MHLW Updates Elective Care LLP List; Target Products Down Sharply to 776
March 9, 2026
- MHLW Orders Label Revisions for Cancer Drugs, Anticoagulant over Bleeding Risk
March 9, 2026
- Japan Health Minister Lauds Approval of iPSC-Based Therapies
March 9, 2026
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…