Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
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
- Panel Backs RSV Antibodies for Japan’s Routine Immunization Program
October 23, 2026
- Japan Weighs Possible Approval Revocation for Tavneos, Action Against Kissei
October 22, 2026
- Hernexeos, Rinvoq, Tukysa Label Expansions Now in Line for Japan Approval
October 22, 2026
- LDP, Ishin Resume Social Security Talks, Chuikyo Reform to Follow
October 22, 2026
- LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
October 20, 2026
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…