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…
REGULATORY
Takeda’s Oveporexton Gets Sakigake Tag for Narcolepsy Type 1
Japan’s health ministry has designated Takeda Pharmaceutical’s oral orexin receptor 2 (OX2R) agonist oveporexton for the sakigake fast-track pathway for the treatment of narcolepsy type 1. The sakigake designation — Japan’s counterpart to the US FDA’s Breakthrough Therapy designation —…
To read the full story
Related Article
- MHLW Withdraws Sakigake Tag for Takeda’s TAK-925
September 17, 2025
- Japan Panel Clears Izervay, Nexletol for Approval; Eylea Biosimilars Edge Ahead Too
September 1, 2025
REGULATORY
- Another LDP Study Group Submits Emergency Proposal Urging Drug Pricing Overhaul
December 5, 2025
- Ishin Urges Takaichi to Revisit OTC-Like Drug Coverage, Softens Savings Target
December 5, 2025
- JPMA Chief Presses LDP Study Group to Lock In On-Patent Prices, Scrap “Spillover” Rule
December 5, 2025
- LDP, Ishin to Continue OTC-Like Drug Talks on “Special Charge” Design
December 5, 2025
- Forxiga, Zytiga Seen Taking Biggest Hit by PMP Returns in FY2026
December 5, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…