ACADEMIA
Study Group Recommends “Reference Groups,” Dose-Escalation Studies to Promote Development of Ultra-Orphan Drugs
A study group backed by the Ministry of Health, Labor and Welfare has issued guidance for promoting the development of “ultra-orphan drugs” for diseases that affect no more than around 1,000 people in Japan. Among other things, the study group,…
To read the full story
Related Article
ACADEMIA
- Arava Safety Backup at Risk as Questran Supply Falters on Nitrosamine Issue
May 11, 2026
- NCC Launches First Japan Trial for CP Inhibitor-Related Liver Dysfunction
April 27, 2026
- Dementia Drugs See Modest Uptake in Japan amid Eligibility Limits, Safety Concerns
April 9, 2026
- Cancer Drug Supply Risks Spur Calls for Pricing Reform: JSMO
March 31, 2026
- Japan Ophthalmology Society Flags Off-Label Concerns Ahead of Upneeq Launch
March 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…





