Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
KalVista Files HAE Drug Sebetralstat in Japan
KalVista Pharmaceuticals has submitted a new drug application in Japan for its investigational plasma kallikrein inhibitor sebetralstat, which could potentially be the country’s first oral on-demand treatment for hereditary angioedema (HAE) attacks. The drug, which targets adults and adolescents aged…
To read the full story
Related Article
- Japan Panel Clears KalVista’s HAE Drug, GSK’s Asthma Agent, and More for Approval
November 28, 2025
- Japan Panel to Review KalVista’s Oral HAE Drug, GSK’s Asthma Med, and More on Nov. 27
November 14, 2025
- Kaken Bags Japan Commercial Rights to KalVista’s HAE Drug
April 10, 2025
- KalVista Eyes Japan Debut with World’s 1st Oral On-Demand HAE Drug
March 14, 2025
BUSINESS
- Leqembi FY2025 Global Sales Reach 88 Billion Yen: Eisai
May 1, 2026
- Rohto Files CMV Corneal Endotheliitis Drug in Japan
May 1, 2026
- Mochida Files in Japan for PAH Drug Tyvaso DPI
May 1, 2026
- Tanabe Clinches EU Approval for Parkinson’s Drug Onerji
May 1, 2026
- 3D “Deeply Disappointed” by Toho Plan to Seek Defense Trigger Approval
May 1, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…