Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Nakai Tapped as MHLW’s Top Pharmacy Officer; Ohara to Steer Drug Pricing Reform
August 7, 2026
- Sarclisa SC, Joenja, Kineret, and 7 More Drugs Bound for NHI Listing
August 6, 2026
- Tepezza Price Cut Set at 5.5% under Japan’s CEA Scheme
August 6, 2026
- Dupixent Faces Fourth Re-Pricing under Japan’s SPA-SSS
August 6, 2026
- Chuikyo Clears NHI Listing for Oncolys’ Telomelysin
August 6, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…