REGULATORY
Sakigake Status Granted to Takeda’s Narcolepsy Med, Ninlaro, Daiichi Sankyo’s Valemetostat and More
The Ministry of Health, Labor and Welfare (MHLW) said on April 8 that it has granted sakigake fast-track designation, the Japan equivalent of the US FDA’s breakthrough therapy status, to five drugs including two from Takeda Pharmaceutical - TAK-925 and…
To read the full story
Related Article
- Rakuten Medical’s Photoimmunotherapy Filed in Japan, Subject to Conditional Early OK
July 1, 2020
- Rakuten Medical Could File Photoimmunotherapy for Head and Neck Cancer in 2022; COO Says More Indications Eyed
June 12, 2019
- Takeda Calls Off PIII Study of Sakigake-Designated Ninlaro for AL Amyloidosis after Failing to Hit Primary Goal
June 7, 2019
- Sakigake Status Goes to World’s 1st Renal-Function Improving Agent, BBB-Penetrating Hunter Syndrome Med and 4 More Drugs
March 28, 2018
- Sakigake Fast-Track Designation Given to Aducanumab, 4 Other Products
April 24, 2017
- 6 Drugs Get Sakigake Designation for Fast-Track Review
October 27, 2015
REGULATORY
- Takaichi Signals Continued Off-Year Revisions despite Abolition Calls
February 26, 2026
- LDP Panel Delays Approval of Health Insurance Bill amid Concerns over OTC-Like Drug Charges
February 26, 2026
- MHLW Orders Colchicine Label Revision, Warns against Doses above 1.5 mg per Day
February 26, 2026
- Symbicort Switch to OTC Status Gains No Support at MHLW Panel
February 25, 2026
- Japan Govt Council Finalizes Recommendations for National MCM Strategy
February 25, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





