BUSINESS
Zolgensma’s Japan Launch Delayed into 2020 as Sakigake Review Drags On, MHLW Still Eager to Make Decision by Year-End
The Japan debut of Novartis’ spinal muscular atrophy (SMA) gene therapy Zolgensma is expected to be delayed into next year as regulators have yet to wrap up its review nearly a year after its filing despite its sakigake tag. Although…
To read the full story
Related Article
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Zolgensma Up for Japan Advisory Panel Meeting on Feb. 26, Listing Expected as Early as May
February 17, 2020
- Zolgensma Not on Roster for Nov. 13 MHLW Panel Review
November 7, 2019
- Novartis’ SMA Gene Therapy Filed in Japan on Nov. 1 after US, EU; What Will Happen to Sakigake Status?
November 13, 2018
- AVXS-101 Is Game Changer for SMA Treatment: Novartis Neuroscience Chief
October 24, 2018
BUSINESS
- Takeda Targets Psoriasis Market with Zasocitinib, Touts Edge in TYK2 Selectivity
March 4, 2026
- Sumitomo Regains Growth Momentum, Eyes 350 Billion Yen from 2 Key Drugs in FY2028
March 3, 2026
- Middle East Turmoil Raises Fears over API Shipments as Key Airports Shut
March 3, 2026
- UCB, Daiichi Sankyo to Wind Up Japan Partnership for Vimpat
March 3, 2026
- Itochu Snaps Up CoreMed to Bolster Japan Entry Support
March 3, 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…





