Major Japanese medical device maker Terumo obtained conditional approval for its cell-based heart failure therapy, HeartSheet, the first such approval given in Japan since a new “regenerative medicine” category was created under the revised pharmaceutical affairs law. HeartSheet, autologous skeletal…
To read the full story
Related Article
- Japan Panel Says No to Full Approval of HeartSheet, Clears Breyanzi’s Broader Label
July 22, 2024
- Terumo Debuts Cell-Based Heart Failure Therapy HeartSheet
May 31, 2016
- Drug Pricing Organization to Price JCR’s Cell Therapy Temcell
October 1, 2015
- Terumo Aims at Annual Sales of 1-2 Billion Yen for HeartSheet within 5-10 Years
September 25, 2015
- PAFSC Committee Recommends Approval for 2 Regenerative Medicine Products
September 4, 2015
BUSINESS
- Japan’s Big 4 Drug Wholesalers See Profit Pressure Intensify in FY2025
May 19, 2026
- Asahi Kasei Starts Japan PIII of Extended Teribone Dosing
May 19, 2026
- Allergan Files Botox Vista for Forehead Wrinkles
May 19, 2026
- Stella Begins Japan PIII of BNCT for Recurrent Glioblastoma
May 19, 2026
- Enhertu Earns 2 US Approvals in HER2-Positive Early Breast Cancer
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…





