Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
To read the full story
Related Article
- Yescarta Sails through PAFSC Review; Panel Roughly OKs Novartis’ Corrective Measures after Zolgensma Delay
December 4, 2020
- Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
September 8, 2020
- Will Zolgensma Delay Spur Revision of Sakigake Designation System?
June 11, 2020
- Zolgensma Hits Japan Market with Stringent Conditions Attached
May 21, 2020
- Chuikyo Members Frown on Zolgensma’s Sakigake Premium; Topic Up for 2022 Pricing Debate
May 14, 2020
- Japan Regulators Upped Zolgensma Price after Novartis Complaints: Chuikyo Paper
May 13, 2020
- Zolgensma to Get Japan’s Highest List Price 167 Million Yen, but Peak Sales Put at Just 4 Billion Yen
May 12, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
- (Update) Japan Approves Novartis’ SMA Gene Therapy Zolgensma; 15-20 Patients Expected Annually
March 19, 2020
- Zolgensma’s Japan Launch Delayed into 2020 as Sakigake Review Drags On, MHLW Still Eager to Make Decision by Year-End
October 23, 2019
REGULATORY
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 2025
- 2024 Reform Spurred New Development Activity, 20 Projects Entered Clinic: Industry Poll
December 11, 2025
- Regenerative Medicine Group Accepts Deferred Debate on Market Expansion Re-Pricing
December 11, 2025
- Wholesalers Urge Price Hikes on Sub-20-Yen Drugs as Negative Margins Mount
December 11, 2025
- Two Bayer/AskBio Gene Therapies Bag Sakigake Designation
December 11, 2025
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…





