REGULATORY

Panel OKs Xarelto’s Label Expansion for Post-Fontan Heart Failure Patients

October 30, 2023
Bayer Yakuhin’s anticoagulant Xarelto (rivaroxaban) on October 27 cleared the review of a key health ministry advisory organ for its additional indication as a thromboprophylaxis in heart disease patients after a Fontan procedure. The Pharmaceutical Affairs and Food Sanitation Council’s…

To read the full story

Related Article

REGULATORY

By Philip Carrigan

In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…

By Takashi Ebisawa

Japan’s Ministry of Health, Labor and Welfare (MHLW) proposed a full review of the so-called “G1/G2” rule — a framework…

By Tatsuya Otsuka

Japan’s drug wholesalers are facing mounting financial pressure as rising logistics and procurement costs deepen losses on product distribution, even…

By Sakura Kono

Japan’s Central Social Insurance Medical Council (Chuikyo) on October 15 approved the reimbursement listing of five new medicines, with the…

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…