Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
J&J’s Subcutaneous Rybrevant Faces Delay in Japan Approval Process
Japan's approval procedure for Janssen Pharmaceutical’s (J&J) subcutaneous formulation of Rybrevant (amivantamab) has been pushed back after the drug was unexpectedly left off the agenda of a health ministry council meeting this month. The product combines Rybrevant with recombinant hyaluronidase…
To read the full story
Related Article
- Data Error Delayed Japan Review of Subcutaneous Rybrevant; Approval Still Expected This Year
October 30, 2025
- J&J Files for 4-Week SC Dosing of Rybrevant in Japan
October 28, 2025
- Japan Approves Pluvicto, Izervay, and Lots More; Subcutaneous Rybrevant Not on Roster
September 22, 2025
- Novartis’ Radioligand Therapy, More Meds Inch Closer to Japan Approval with Panel OK
August 25, 2025
REGULATORY
- MHLW to Allow OTC Drugs to Match Prescription Doses under Specific Conditions
February 5, 2026
- Japan Launches Biotechnology Working Group, Roadmap Draft Due in April
February 4, 2026
- Japan Panel Backs Nonprescription Switch of Second Emergency Contraceptive
February 4, 2026
- MHLW Set to Launch Searchable Drug Supply Database in April
February 3, 2026
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 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…