REGULATORY

BMS’ Second CAR-T Therapy Ide-Cel in Line for Approval in January

December 7, 2021

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Bristol Myers Squibb’s second CAR-T cell therapy idecabtagene vicleucel (ide-cel) cleared a key Japanese health ministry advisory committee on December 6. This opens the way for its official approval as early as January as the country’s fourth CAR-T product. Ide-cel,…

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Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

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

COLUMN

The Strategic MSL: Beyond Data Delivery, It’s About Impact

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…

COMMENTARY

Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?

By Hayate Horiguchi

Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…