Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Panel Clears New Drugs from MSD, Pfizer, Amicus for Approval
Three new medicines gained the blessing of a key health ministry panel on June 4 that sets the stage for their Japanese regulatory approvals, including MSD’s sotatercept and Pfizer’s etrasimod. Sotatercept was recommended approval by the Pharmaceutical Affairs Council’s First…
To read the full story
Related Article
- Mochida’s Low-Dose Lialda to Hit Shelves in September
August 19, 2025
- Japan Approves MSD’s Airwin/Welireg, J&J Bispecific, and More
June 25, 2025
- Pfizer’s UC Drug, MSD’s PAH Therapy, and More Up for Panel Review on June 4
May 22, 2025
- MSD Files PAH Treatment Sotatercept in Japan
November 15, 2024
- Amvuttra Filed for ATTR-CM in Japan: Alnylam
November 12, 2024
- Aculys Pharma Files Diazepam Nasal Spray in Japan
September 3, 2024
- Tremfya Filed for Crohn’s Disease in Japan: J&J
August 13, 2024
- Takeda Seeks CIDP Nod for Immunoglobulin Hyqvia in Japan
August 9, 2024
- Mochida Files Pediatric Dosage of UC Drug Lialda in Japan
July 23, 2024
- Pfizer Seeks Japan Approval for Ulcerative Colitis Drug
July 1, 2024
- Mundipharma Files Anesthetic Med Anerem for New Indication in Japan
September 28, 2023
REGULATORY
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
February 27, 2026
- Executives Urge Stronger CDMO, CRO Base at Drug Discovery WG Meeting
February 27, 2026
- Japan to Closely Monitor US “MFN” Policy: PM Takaichi
February 27, 2026
- Japan to Update Adult Pneumococcal Fact Sheet Ahead of Capvaxive NIP Review
February 27, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…