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
- Unpacking “MFN”: Japan Listed as Reference Country in US Pricing Models
April 16, 2026
- MHLW Taps Kawabata to Lead Drug Discovery Support Office
April 15, 2026
- MHLW Reviewing EMIS Data on Petro-Product Supply to Medical Institutions
April 15, 2026
- Japan Panel to Review Ferring Gene Therapy, Fujifilm Cell Product on April 20
April 14, 2026
- LDP, Ishin to Explore Role of Private Insurance in Reform Talks
April 14, 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…





