Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
REGULATORY
Japan Panel Clears KalVista’s HAE Drug, GSK’s Asthma Agent, and More for Approval
A Japanese health ministry panel on November 27 endorsed approvals for seven new molecular entities (NMEs) — including KalVista Pharmaceuticals’ on-demand hereditary angioedema (HAE) therapy sebetralstat, known overseas as Ekterly. The Pharmaceutical Affairs Council’s Second Committee on Drugs backed sebetralstat,…
To read the full story
Related Article
- Nipro-Samsung Alliance Nears First Approval in Japan with Stelara Biosimilar
November 14, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
- Tecentriq Filed for Thymic Carcinoma in Japan: Chugai
May 15, 2025
- Nippon Shinyaku Files BPDCN Drug in Japan
March 31, 2025
- Sanofi Japan Files Dupixent for Asthma in Children Aged 6-11
February 12, 2025
- GSK Files Depemokimab for Asthma and CRSwNP in Japan
January 29, 2025
- KalVista Files HAE Drug Sebetralstat in Japan
January 29, 2025
REGULATORY
- LDP Leans Towards “Special Charges” for OTC-Like Drugs, Not Coverage Removal
December 15, 2025
- Ishin Urges “Special Charge” Scheme for OTC-Like Drugs, Eyes FY2026 Launch
December 15, 2025
- Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests
December 15, 2025
- LDP Tax Panel OKs New 40% R&D Credit for Strategic Technologies
December 12, 2025
- Pharma Renews Call to Scrap “Spillover,” “Huge-Seller” Rules as FY2026 Talks Enter Final Stretch
December 11, 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…