The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Novartis’ Fabhalta, Novo’s Awiqli, and More Up for PAFSC Review on May 31
Novartis Pharma’s paroxysmal nocturnal hemoglobinuria (PNH) treatment iptacopan and Novo Nordisk Pharma’s once-weekly insulin icodec will come up for approval review by a key health ministry advisory panel on May 31. Iptacopan, known as Fabhalta overseas, is among the four…
To read the full story
Related Article
- Japan Health Ministry Panel Gives Blessing to Novartis’ PNH Drug Iptacopan and More
June 4, 2024
- Tapinarof Cream Hits Main Goal in PIII Eczema Trial in Children: JT/Torii
June 3, 2024
- JT Files Tapinarof Cream for Eczema, Psoriasis in Japan
September 19, 2023
- AbbVie Files Skyrizi for Ulcerative Colitis in Japan
September 15, 2023
- Novo Nordisk Files Once-Weekly Basal Insulin in Japan
August 10, 2023
- UCB Submits Anti-Epileptic Drug Brivaracetam in Japan
July 31, 2023
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
- 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
- MHLW Council Determines 3 “Drug Loss” Products as High-Need, to Seek Development
December 16, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
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…
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…