Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
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
- Japan Panel to Review Kyowa Kirin’s Libmeldy for Approval on Nov. 9
November 4, 2026
- PMDA Sets Out AI Principles for Regulatory Activities, Stresses Human Oversight
November 4, 2026
- Public-Private Pharma Talks Expand to Domestic R&D, Manufacturing Investment
November 2, 2026
- Japan’s Healthcare Spending Hits Record 48.8 Trillion Yen in FY2024
November 2, 2026
- PMDA Renews Warning on Off-Label GLP-1 Use amid Adverse Event Reports
November 2, 2026
Analysis of individual placements across 43 companies over the past 18 months paints a vivid picture of Japan’s evolving healthcare industry. This comprehensive snapshot illuminates current market demands, strategic shifts, and the enduring appeal of this pivotal Asian market.Rare Diseases…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Japan’s pharmaceutical industry asked the ruling Liberal Democratic Party (LDP) on October 29 to boost the country’s drug supply security…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…