Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Label Revision Ordered for Opdivo, Yervoy to Add Meningitis Risks
The Ministry of Health, Labor and Welfare (MHLW) on June 13 ordered label revisions for Ono Pharmaceutical’s Opdivo (nivolumab) and Bristol Myers Squibb’s Yervoy (ipilimumab) to flag a side effect risk of meningitis. Meningitis will be added to the clinically…
To read the full story
Related Article
- PMDA Reviewing Safety Risks for Opdivo, Yervoy
May 22, 2023
REGULATORY
- Japan Sets Up Radiopharma Discovery Hub in Fukushima, Targets Rare Cancers
March 18, 2026
- MHLW Seeks Industry Survey on Petroleum-Linked Products amid Iran Crisis
March 18, 2026
- MHLW Orders Label Revisions for Antiepileptics and Other Drugs
March 18, 2026
- MHLW Panel OKs Draft Criteria for “Specified Medical Technologies”
March 17, 2026
- Growth Strategy Council WG Weighs Incentives for Clinical Trial Sites
March 17, 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…