REGULATORY
Second CAR-T Therapy Yescarta Up for Panel Review; MHLW to Report Corrective Measures for Zolgensma Issue
A key health ministry advisory committee will discuss whether to recommend approval for Daiichi Sankyo’s CAR-T cell therapy axicabtagene ciloleucel, known as Yescarta overseas, at its meeting on December 3. If approved, it will be the second CAR-T product, after…
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
- Novartis’ Flawed and Delayed Inquiry Responses in Zolgensma Review “Extremely Unusual”: PMDA Report
April 16, 2020
- Novartis Japan Chided over Flawed Zolgensma Data, Delayed Responses
April 8, 2020
- Daiichi Sankyo Files Yescarta, Second CAR-T Therapy in Japan
March 30, 2020
REGULATORY
- LDP, Ishin Fail to Seal Deal on OTC-Like Drugs as Talks Stall over Fiscal-Savings Figure
December 18, 2025
- Japan Moves LLP Payment Hike toward Political Call, Eyes 1/2 or Higher
December 18, 2025
- Panel to Weigh Orphan Designation for Tecartus on December 22
December 17, 2025
- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
December 17, 2025
- Solo Distribution Poses Threats to Stable Supplies, Price Negotiations: Survey
December 17, 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…





