#NewProduct

The Pharmaceuticals and Medical Devices Agency panel has determined that the human (allogeneic) iPS cell-derived cardiomyocyte sheet IPSOC-1 can be approved with conditions and time limitations, and formal approval by the Ministry of Health, Labour and Welfare is expected.

Manufacturing and marketing approval obtained from the Ministry of Health, Labour and Welfare for the Influenza Virus Nucleic Acid Kit "GeneSoC FluA/B Detection Kit," scheduled for sales launch in the first half of fiscal 2026.

Achieved primary endpoints in the Phase III trial of Daridorexant in South Korea; manufacturing and marketing approval application planned for Q1 2026, with approval expected in Q1 2027.

Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug "Zazvey® Capsules 30mg" in Japan and has launched it in the market as a novel mechanism of action treatment with rapid onset.

Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug 'Zavege® Capsules 30mg' in Japan and has started market launch as a novel mechanism of action treatment with rapid efficacy.

Astellas Pharma announced that the combination therapy of PADCEV (Enfortumab Vedotin) and Pembrolizumab improved event-free survival and overall survival in cisplatin-eligible muscle-invasive bladder cancer in the Phase III EV-304 trial.

Zasositinib (TAK-279) achieved primary endpoints in a Phase 3 clinical trial targeting patients with moderate to severe plaque psoriasis, with over half achieving PASI90 and approximately 30% achieving PASI100 at week 16.

Takeda Pharmaceutical Company Limited, in collaboration with Protagonist Therapeutics, announced 52-week data from the Phase 3 VERIFY trial of rusfertide in patients with polycythemia vera, demonstrating sustained hematocrit control and safety.