REGULATORY
Japan Doles Out Orphan Tags for 10 APIs, Pulls Status for Biogen’s MS Drug
Japan’s Ministry of Health, Labor and Welfare (MHLW) on August 28 designated 10 APIs as orphan drugs while withdrawing such designation for Biogen Japan’s multiple sclerosis (MS) treatment fampridine. Fampridine had been designated as an orphan drug in March 2016…
To read the full story
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
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…





