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
- LDP Project Team Flags Drug Pricing as Key to Investment
March 19, 2026
- Japan Sets Up Radiopharma Discovery Hub in Fukushima, Targets Rare Cancers
March 18, 2026
- MHLW Seeks Industry Survey on Petroleum-Linked Products amid Iran Crisis
March 18, 2026
- MHLW Orders Label Revisions for Antiepileptics and Other Drugs
March 18, 2026
- MHLW Panel OKs Draft Criteria for “Specified Medical Technologies”
March 17, 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…





