REGULATORY

MHLW Orders Label Revisions for Keytruda, Tecentriq, and More

January 11, 2024
The Ministry of Health, Labor and Welfare (MHLW) on January 10 issued a notification ordering label revisions for a batch of medicines, including I/O therapies Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for the risk of myelitis. Myelitis will be added to…

To read the full story

Related Article

REGULATORY

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Philip Carrigan

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…

By Tatsuya Otsuka

Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…

Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

By Ken Yoshino

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…