REGULATORY

Panel OKs Ofev for PF-ILD; Label Expansion for Xtandi/Erleada, Prevenar and More

May 25, 2020
Nippon Boehringer Ingelheim’s tyrosine kinase inhibitor Ofev (nintedanib) has grabbed the nod of a key health ministry panel for an additional indication of progressive fibrosing interstitial lung disease (PF-ILD), setting the stage for its official stamp of approval as early…

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 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…

By Tatsuya Otsuka

Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…

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…