REGULATORY

MHLW Committee on Medical Devices Recommends Approval of 2 Cancer Gene Panel Tests

December 17, 2018
A health ministry panel on December 13 recommended approval of two cancer gene panel test kits from Sysmex and Chugai Pharmaceutical. Official regulatory approval is normally granted within one month after the committee’s recommendation. If approved, the two products will…

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REGULATORY

Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

By Shinya Sato

More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…

By Philip Carrigan

A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…

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…