REGULATORY

Shelf Life of Ronapreve, Xevudy Extended to 30 Months in Japan

March 1, 2023
Japanese regulatory authorities have announced the extension of the shelf life for two COVID-19 antibody therapies, Ronapreve (casirivimab/imdevimab) and Xevudy (sotrovimab), which were respectively developed by Chugai Pharmaceutical and GlaxoSmithKline.The original shelf life of both products was 24 months when…

To read the full story

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

The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…

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…