REGULATORY
PAFSC’s 1st Committee on New Drugs Recommends Orphan Drug Designation for 2 Products Including Kyowa Kirin’s Cinacalcet
At a meeting on November 30, the Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) First Committee on New Drugs recommended the orphan drug designation for two products, including Kyowa Hakko Kirin’s cinacalcet HCl for the expected indication of hypercalcemia associated…
To read the full story
REGULATORY
- 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
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
December 16, 2025
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 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…





