REGULATORY
Will Japan Reinstate Sakigake Status for Aducanumab? Many See It Unlikely
Speculation is growing that Japanese regulators will not reinstate its sakigake fast-track designation for Biogen’s Alzheimer’s drug aducanumab, which made a surprising comeback last month with the company announcing a plan to seek approval. The word is that the medicine…
To read the full story
Related Article
- In Shocking U-Turn, Biogen/Eisai Say to File Aducanumab in Early Next Year
October 23, 2019
- Sakigake Status Withdrawn for Aducanumab: MHLW
September 20, 2019
REGULATORY
- MOF Pushes for Full-Scale FY2027 Off-Year Drug Price Revision Ahead of “Spring” Proposal
April 28, 2026
- Japan Panel Backs Boehringer’s IPF Drug, Moderna COVID Vaccine
April 28, 2026
- Japan Allows Flexibility on Pharmacopoeia Test Differences in Supply Crunch
April 28, 2026
- Zepbound in Line for OSA Approval after Key Panel Nod
April 27, 2026
- LDP Team Urges Patent-Period Price Maintenance, CEA Review in Growth Strategy Proposal
April 27, 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…





