Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Label Revisions Ordered for Opdivo, Yervoy, Duvroq, and More
The Ministry of Health, Labor and Welfare (MHLW) on July 17 ordered label revisions for a batch of medicines, including the PD-1 inhibitor Opdivo (nivolumab) and the CTLA-4 inhibitor Yervoy (ipilimumab) for a new safety risk of myelitis. The myelitis…
To read the full story
Related Article
- PMDA Reviewing Safety Risks for Duvroq, Opdivo, and More
June 24, 2024
REGULATORY
- Unpacking “MFN”: Japan Listed as Reference Country in US Pricing Models
April 16, 2026
- MHLW to Set Criteria for Exemptions under OTC-Like Drug Charge Scheme
April 16, 2026
- MHLW Taps Kawabata to Lead Drug Discovery Support Office
April 15, 2026
- MHLW Reviewing EMIS Data on Petro-Product Supply to Medical Institutions
April 15, 2026
- Japan Panel to Review Ferring Gene Therapy, Fujifilm Cell Product on April 20
April 14, 2026
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 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,…
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…