Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Eisai Seeks Label Expansion for Fycompa to Include Monotherapy
Eisai said on September 27 that it has filed a supplemental application for its antiepileptic drug Fycompa (perampanel) in the US, proposing that its use as monotherapy for partial-onset seizures be included in its label. Specifically, the company is seeking…
To read the full story
BUSINESS
- Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
March 6, 2026
- Sawai Pharmaceutical to Promote Toshiomi Nakate to President
March 6, 2026
- Asahi Kasei Pharma to Rebrand as Asahi Kasei Therapeutics in April
March 6, 2026
- Keytruda Maintains Top Spot for 29 Straight Months in February: Encise
March 6, 2026
- Takeda Files Japan NDA for Narcolepsy Drug Oveporexton
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…