Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Add Rhabdomyolysis to Nexium Label: MHLW
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on February 16, calling for the revision of the package insert for the proton pump inhibitor (PPI) esomeprazole (brand name: Nexium) to add rhabdomyolysis as a clinically significant adverse…
To read the full story
Related Article
- Oculomucocutaneous Syndrome, Erythema Multiforme Added to ADR List for Halaven
March 16, 2016
- PMDA Reviewing Nexium for Risk of Rhabdomyolysis
January 25, 2016
REGULATORY
- Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
- Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
March 6, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan's Revised Drug Distribution Guidelines Take Effect
March 6, 2026
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…