Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Panel Clears Amgen’s TED Med, Rexulti for Alzheimer’s Agitation and More
A batch of new medicines including Amgen’s thyroid eye disease (TED) drug teprotumumab, known as Tepezza overseas, were recommended for regulatory approval by a Japanese health ministry panel on August 26. The Pharmaceutical Affairs Council’s First Committee on Drugs, a…
To read the full story
Related Article
- Fuji Pharma Kicks Off Japan PIII for Alyssa in Endometriosis
July 28, 2025
- Japan Approves Lilly’s Kisunla, Eisai’s ALS Med, Gilead’s Trodelvy, and Lots More
September 25, 2024
- High-Dose Mecobalamin Now in Line to Become Japan’s 1st ALS Med in 9-Plus Years
August 28, 2024
- Evrysdi Filed for Pre-Symptomatic SMA in Japan: Chugai
February 16, 2024
- Eisai Resubmits Ultra-High Dose Mecobalamin in Japan for ALS
January 29, 2024
- Amgen Files TED Drug Tepezza in Japan
January 17, 2024
- DyDo Pharma Files Its 1st Drug, LEMS Treatment for Japan Market
December 19, 2023
- Otsuka Files NDA for Lupus Nephritis Drug in Japan
November 13, 2023
- Otsuka Files Rexulti for Alzheimer’s Associated Agitation in Japan
November 1, 2023
- Idorsia Files Insomnia Med Daridorexant in Japan: Sosei, Mochida
November 1, 2023
- Janssen Files PAH Fixed-Dose Combo Drug in Japan
October 24, 2023
- Fuji Pharma/M3’s Dysmenorrhea Drug Filed in Japan, 2024 Rollout Targeted
October 19, 2023
REGULATORY
- Takaichi Signals Continued Off-Year Revisions despite Abolition Calls
February 26, 2026
- LDP Panel Delays Approval of Health Insurance Bill amid Concerns over OTC-Like Drug Charges
February 26, 2026
- MHLW Orders Colchicine Label Revision, Warns against Doses above 1.5 mg per Day
February 26, 2026
- Symbicort Switch to OTC Status Gains No Support at MHLW Panel
February 25, 2026
- Japan Govt Council Finalizes Recommendations for National MCM Strategy
February 25, 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…