REGULATORY

Chugai’s Entrectinib Up for Review for NTRK Tumors on May 30; Label Expansions for Lynparza, Cyramza Also on Agenda

May 17, 2019
Chugai Pharmaceutical’s ROS1/TRK inhibitor entrectinib will come up for review by a key health ministry panel on May 30 for the treatment of NTRK gene fusion-positive solid tumors. If cleared, it will be approved as early as June as the…

To read the full story

Related Article

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…