The PD-1 receptor, a major immune checkpoint inhibitor whose signaling is the target of multiple blockbuster anticancer drugs, differs functionally between rodents and humans in previously unknown ways. Researchers from the University of California, San Diego, and co-authors at the Chinese Academy of Sciences and the National Cancer Institute reported these findings in the Jan. 3, 2025, online issue of Science Immunology.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alentis, Bayer, DBV, Karolinska, Genascence, Inmagene, Maat Pharma, Rapport , Sanofi, Seres.
The U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will scrutinize Jan. 10 the safety and efficacy of Ferring Pharmaceuticals Inc.’s SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc hernia.
It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched the number of biologics referenced by biosimilars from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024.
Modest signs of recovery were seen in the biopharma IPO market in 2024, though activity remains significantly below the levels seen during the 2018-2021 boom. In 2024, 32 biopharma companies went public, a slight increase from 27 in 2023 but a decline from 35 in 2022. These figures pale in comparison to the peak years, with 134 IPOs in 2021, 106 in 2020 and even 65 in 2019. Both the total value and volume of IPOs continue to lag far behind those earlier highs.
Top-line data from Maat Pharma SA’s phase III study of MaaT-013, an enema microbiome ecosystem therapy for acute graft-vs.-host disease, hit its primary endpoint. The milestone has prompted the company to think about filing an MAA submission for the treatment in Europe sometime in the middle of 2025, which is earlier than it had anticipated.
Coave Therapeutics SA has completed the transition to becoming a genetic medicines specialist, after divesting its single ophthalmology program and raising $33 million in a series A round.
New Anglo/U.S. obesity and cardiometabolic specialist Verdiva Bio Ltd. has launched with a massive $411 million series A and a portfolio of GLP-1 and amylin agonists in-licensed from China.
RSS
