REGULATORY

CSL’s HAE Drug, Tecentriq Up for Panel Review on Jan. 30; 1st Cases of Expedited Approval

By Takashi Ebisawa January 17, 2025
A key health ministry advisory panel will discuss on January 30 whether to recommend approval for CSL Behring’s hereditary angioedema (HAE) treatment garadacimab and a label expansion for Chugai Pharmaceutical’s PD-L1 inhibitor Tecentriq (atezolizumab). Starting this year, the Ministry of…

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 Shinya Sato

AAV (adeno-associated virus) gene therapies are moving beyond rare diseases into more prevalent conditions, with neovascular, or wet, age-related macular…

By Philip Carrigan

In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…

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…