Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
US FDA Accepts sNDA for Fycompa: Eisai
The US FDA has accepted a supplemental new drug application (sNDA) for Eisai’s antiepileptic drug Fycompa (perampanel) for adjunctive treatment of primary generalized tonic-clonic seizures (PGTC) in patients aged 12 and older. Applications for this indication were filed with both…
To read the full story
BUSINESS
- Sumitomo Regains Growth Momentum, Eyes 350 Billion Yen from 2 Key Drugs in FY2028
March 3, 2026
- Middle East Turmoil Raises Fears over API Shipments as Key Airports Shut
March 3, 2026
- UCB, Daiichi Sankyo to Wind Up Japan Partnership for Vimpat
March 3, 2026
- Itochu Snaps Up CoreMed to Bolster Japan Entry Support
March 3, 2026
- Ono to Transfer Opalmon, Prostandin to Daito by November
March 3, 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…