Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Fycompa Generics Approved despite Extended Patent, Hydrate Switch in Play?
Quick Look: Generics of Eisai’s Fycompa won approval despite an extended patent running through June, pointing to a possible hydrate-to-anhydrous switch to bypass protection. Whether the strategy will succeed remains unclear, given mixed precedents in recent patent disputes. ----- Generic…
To read the full story
Related Article
- Sawai Cedes to Merck in Januvia Row, Accepts Patent Scope
February 4, 2026
- Sawai Wins Lawsuit over CML Use in Sprycel Generic
May 19, 2025
BUSINESS
- Nitrosamine Detected in Nichi-Iko’s Tryptanol, No Need to Halt Prescriptions
March 9, 2026
- Pfizer, ASKA to Co-Promote RSV Vaccine Abrysvo in Japan
March 9, 2026
- Towa Broadens Label for Tacrolimus in Cell Transplantation
March 9, 2026
- Japan Ethical Drug Sales Up 1.2% in January: Crecon
March 9, 2026
- Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
March 6, 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…