The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Japan Approves CSL’s HAE Med Andembry, Tecentriq Sarcoma Use, and More
Japan’s health ministry awarded regulatory approvals for a batch of drugs mostly for new indications and dosages on February 20. This includes CSL Behring’s hereditary angioedema (HAE) treatment Andembry (garadacimab), the only new molecular entity on the roster. Andembry was…
To read the full story
Related Article
- CSL’s New HAE Drug Andembry Now Available in Japan
April 21, 2025
- Amgen’s Imdelltra, CSL’s Andembry to Join NHI Price List on April 16
April 10, 2025
- 1st CP Inhibitor Approved for Sarcoma, Could This Be a Breakthrough to Treatment of More Subtypes?
February 25, 2025
- Lixiana Now Set for Label Expansion; 11 Drugs to Get Orphan Tags
February 3, 2025
- CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
January 31, 2025
- CSL’s HAE Drug, Tecentriq Up for Panel Review on Jan. 30; 1st Cases of Expedited Approval
January 17, 2025
- Humira Filed for nr-axSpA in Japan Based on Public Knowledge: AbbVie
September 2, 2024
- Japan to Increase Reimbursement Rounds to 7 Times a Year from 2025
May 16, 2024
- Sanofi Files Sarclisa as 1st-Line Quad Therapy for MM in Japan
May 15, 2024
- Tecentriq Filed for Alveolar Soft Part Sarcoma in Japan: Chugai
March 15, 2024
- Genmab Files Epkinly for Follicular Lymphoma Grade 1-3A in Japan
March 12, 2024
REGULATORY
- OTC-Like Drugs Left in Limbo as Panel Debates Cost-Sharing without Clear Policy Signal
December 19, 2025
- LDP, Ishin Fail to Seal Deal on OTC-Like Drugs as Talks Stall over Fiscal-Savings Figure
December 18, 2025
- Japan Moves LLP Payment Hike toward Political Call, Eyes 1/2 or Higher
December 18, 2025
- 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
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…