REGULATORY

Astellas’ Izervay, Otsuka’s Nexletol among New Drugs Up for Japan Panel Review; Eylea Biosimilars Also on Agenda

August 19, 2025
Japan’s health ministry will convene the Pharmaceutical Affairs Council’s First Committee on Drugs on August 29 to review a slate of applications, including six new molecular entities (NMEs) — some positioned as next-generation growth drivers for major firms. The agenda…

To read the full story

Related Article

REGULATORY

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

By Sakura Kono

Japan is poised to make the most sweeping revision in eight years to the Standards for Biological Raw Materials —…

By Philip Carrigan

The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…

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…