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- Sakigake Status Withdrawn for Aducanumab: MHLW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
- 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
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.…





