Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
PNH Drug Crovalimab Accepted for FDA Review: Chugai
Chugai Pharmaceutical said on September 6 that the US FDA has accepted for review a regulatory application for the company’s anti-C5 recycling monoclonal antibody crovalimab for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The filing is based on data from…
To read the full story
Related Article
- Chugai Files NDA for PNH Drug Crovalimab in Japan
June 15, 2023
BUSINESS
- Lilly Discloses Japan Filing for Orforglipron, Starting with Obesity
February 6, 2026
- Ono Recalls Certain Opdivo Lots over Possible Metal Contamination
February 6, 2026
- Eisai Snares Japan Commercial Rights to Henlius’ PD-1 Inhibitor
February 6, 2026
- Takeda Rolls Out 31-Foot Containers for Drug Transport
February 6, 2026
- Okajima to Take Helm of Asahi Kasei Pharma in April
February 6, 2026
Japan’s Biological Raw Material Rules Enter Major Revision; Clarity on Benefits and Safety Holds Key
Japan is poised to make the most sweeping revision in eight years to the Standards for Biological Raw Materials —…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…