Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
ALS Treatment Ozanezumab Designated as Orphan Drug: GSK
GlaxoSmithKline (GSK) K.K. announced on May 17 that its investigational amyotrophic lateral sclerosis (ALS) treatment ozanezumab was granted orphan drug designation by the Ministry of Health, Labor and Welfare (MHLW) on May 13. The agent is in the PII clinical…
To read the full story
BUSINESS
- Takeda Files Japan NDA for Narcolepsy Drug Oveporexton
March 5, 2026
- Nxera Files for Daridorexant Approval in South Korea
March 5, 2026
- Sawai Prevails in Patent Suit against Viatris over Amitiza Generic
March 5, 2026
- Kyowa Kirin Halts Rocatinlimab Clinical Trials on Malignancy Concerns
March 4, 2026
- Meiji’s Morcamilast Wins EU Orphan Tag for Palmoplantar Pustulosis
March 4, 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…