REGULATORY
Japan to Set Up Dedicated Team to Expedite Review of Sakigake-Designated Cell/Gene Therapies
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will establish a team dedicated to reviewing cell and gene therapies designated for its sakigake fast-track pathway in FY2020 as it gears up for a flurry of approvals for these up-and-coming products. Funds…
To read the full story
Related Article
REGULATORY
- LDP Biosimilar Group Submits Request to Finance Minister, Seeks Continued Support
December 16, 2025
- LDP’s Patch League Urges Finance Minister to Continue Coverage, Support Prices
December 16, 2025
- Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
December 15, 2025
- LDP Leans Towards “Special Charges” for OTC-Like Drugs, Not Coverage Removal
December 15, 2025
- Ishin Urges “Special Charge” Scheme for OTC-Like Drugs, Eyes FY2026 Launch
December 15, 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…





