Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Data Error Delayed Japan Review of Subcutaneous Rybrevant; Approval Still Expected This Year
Japan’s Ministry of Health, Labor and Welfare (MHLW) disclosed on October 29 that the approval process for Janssen Pharmaceutical’s (J&J) subcutaneous formulation of Rybrevant (amivantamab) had been temporarily put on hold due to a data error in the company’s application…
To read the full story
Related Article
- Japan Approves Batch of New Drugs, Subcutaneous Rybrevant Finally Cleared
December 23, 2025
- Japan Approves Label Expansions for Braftovi, Augtyro, Uplizna, and More
November 21, 2025
- Label Expansion of Braftovi, Augtyro, Lunsumio SC Up for MHLW Panel Review
October 16, 2025
- J&J’s Subcutaneous Rybrevant Faces Delay in Japan Approval Process
September 17, 2025
- Pfizer Files Anaemetro’s Pediatric Use; Coverage Already Granted
May 26, 2025
- Darzquro Filed for High-Risk Smoldering MM in Japan: J&J
February 17, 2025
- AbbVie Files Venclexta for Untreated CLL in Japan
December 23, 2024
- BMS Files Augtyro for NTRK-Positive Solid Tumors in Japan
December 16, 2024
REGULATORY
- Ishin Proposes Adding Drug, Device Makers to Chuikyo, LDP Wary
June 10, 2026
- Cabinet Approves Immunization Act Revision to Cover Antibody Drugs
June 10, 2026
- LDP Lawmakers Seek Routine HPV Vaccinations for Males by April 2027
June 10, 2026
- LDP Team Seeks Minister-Led AI Task Force at MHLW
June 10, 2026
- MHLW to Continue Reviewing Tavneos Safety Measures: Official
June 10, 2026
Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…
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…
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…