REGULATORY
CSL’s HAE Drug, Tecentriq Up for Panel Review on Jan. 30; 1st Cases of Expedited Approval
A key health ministry advisory panel will discuss on January 30 whether to recommend approval for CSL Behring’s hereditary angioedema (HAE) treatment garadacimab and a label expansion for Chugai Pharmaceutical’s PD-L1 inhibitor Tecentriq (atezolizumab). Starting this year, the Ministry of…
To read the full story
Related Article
- Japan Approves CSL’s HAE Med Andembry, Tecentriq Sarcoma Use, and More
February 21, 2025
- CSL’s HAE Drug, Tecentriq Sarcoma Use Clear Panel Review; February Approval Expected
January 31, 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
REGULATORY
- Japan to Start CEA Technical Discussions as Early as May 25
May 20, 2026
- LDP Study Group’s Honebuto Proposal Urges “Freeze” on On-Patent Drug Price Cuts
May 20, 2026
- PMDA Flags Iron Products, ST Combination Drug in Risk Review
May 20, 2026
- MHLW Orders Detailed Report on Tavneos Efficacy Concerns
May 20, 2026
- Japan Approves Jascayd, mNEXSPIKE, Zepbound OSA Use, Others
May 19, 2026
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…





