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
- Espha to Reinvest AG Profits into New Biz after Reform; Xarelto AG Logs 19 Billion Yen
May 15, 2026
- Meiji Opposes French Fund’s Push to Review Pharma Spin-Off
May 15, 2026
- FRONTEO Opens AI Drug Discovery Lab, Pivots to Out-Licensing Model
May 15, 2026
- Inqovi-Venetoclax Combo Wins FDA Approval in AML: Taiho
May 15, 2026
- Chugai Files Gazyva for Idiopathic Nephrotic Syndrome in Japan
May 15, 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…





