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
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
- LDP Study Group’s Honebuto Proposal Urges “Freeze” on On-Patent Drug Price Cuts
May 20, 2026
- PMDA Flags Iron Products, ST Combination Drug in Risk Review
May 20, 2026
- MHLW Orders Detailed Report on Tavneos Efficacy Concerns
May 20, 2026
- Japan Approves Jascayd, mNEXSPIKE, Zepbound OSA Use, Others
May 19, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
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…