REGULATORY
Keytruda’s Sakigake Designation Revoked after Opdivo Gastric Cancer Nod
A health ministry panel on September 28 approved the withdrawal of a sakigake fast-track designation for MSD’s anti-PD-1 antibody Keytruda (pembrolizumab) as a gastric cancer treatment after its archrival in the class, Opdivo (nivolumab), earned the nod for the indication.…
To read the full story
REGULATORY
- 679 Safety Reports Logged for Regenerative Medical Products in 2H FY2025
August 21, 2026
- Japan Panel to Discuss Approval of 6 NMEs, Leqembi SC on Aug. 26
August 20, 2026
- DPP Lawmaker Calls for Inflation Relief in 2027 Off-Year Drug Price Revision
August 19, 2026
- CEA Review Group Wraps Up Technical Debate, Urges More Company Access
August 19, 2026
- Japan Panel to Weigh Keytruda SC, J&J Psoriasis Pill among 6 NMEs on Aug. 24
August 18, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…





