REGULATORY

Takeda’s RCC Drug Cabometyx in MHLW Panel’s Review Roster for January 29; Alecensa, Opdivo and More

January 16, 2020
A key health ministry advisory panel will discuss whether to recommend approval for Takeda Pharmaceutical’s renal cell carcinoma (RCC) treatment cabozantinib, which was licensed from US biotech Exelixis, on January 29. If cleared by the panel, the drug would gain…

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REGULATORY

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Shinya Sato

Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…

By Philip Carrigan

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,…

By Ken Yoshino

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…