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
MSD’s Welireg, BMS’ Inrebic, J&J’s Talvey Now in Line for Japan Approval
A Japanese health ministry panel on June 6 gave the thumbs-up for the approval of three new medicines, all designated as orphan drugs, including MSD’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan. Belzutifan, known as Welireg overseas, gained the backing…
To read the full story
Related Article
- Japan Approves MSD’s Airwin/Welireg, J&J Bispecific, and More
June 25, 2025
- MSD’s Welireg, BMS’ Inrebic, J&J’s Talvey Up for Japan Panel Review on June 6
May 26, 2025
- MM Drug Talquetamab Filed in Japan: J&J
November 21, 2024
- MSD Files Belzutifan for von Hippel-Lindau Disease in Japan
September 18, 2024
- Rinvoq Filed for Giant Cell Arteritis in Japan: AbbVie
August 19, 2024
- Opdivo-Yervoy Combo Filed for HCC in Japan
August 13, 2024
- MSD Seeks Japan Nod for RCC Med Belzutifan
July 23, 2024
REGULATORY
- Vimpat Draws 10 Generic Entrants in December Listing; Forxiga Has Two, but Nipro AG Absent
December 4, 2025
- MHLW Floats Deducting Private-Practice Use for Re-Pricing, but Off-Cycle Cuts Possible; GLP-1 Eyed?
December 4, 2025
- Bayer’s Eylea Bio-AG Finally Reaches NHI Listing amid Reform Talks
December 4, 2025
- MHLW Panel Green-Lights Approval for Kissei’s Uterine Fibroid Drug, 3 More NMEs
December 4, 2025
- MHLW Proposes Pricing New AGs and Bio-AGs on Par with Originators
December 4, 2025
As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…
Japan’s drug pricing panel on November 19 discussed a wide range of potential pricing changes related to patent-protected medicines, including…
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…