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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
2024 saw the completion of several cellular-resolution brain maps, including the entire fly brain and a comprehensive connections map of a cubic centimeter of human brain. 2025 began with the addition of another important map. In the Jan. 1, 2025, issue of Nature, researchers from the Allen Institute presented a map of areas and cell types where aging most affected the mouse brain. Read More
The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future. Read More
BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025. Read More
BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the financing trends of the past year and the regulatory actions likely to affect med-tech into 2025. Read More
Biopharmas raising money in public or private financings, including: Acurx, Alesta, Aspect, Citius, Hemogenyx, Maze, Neumirna, Tenvie, Uniqure. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anokion, Bioinvent, Bitterroot, Camp4, Crystal, Eirion, Insilico, Jasper, LB Pharmaceuticals, Sana, Vir. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 1cbio, Acepodia, Alesta, Alloy, Alpha Cognition, Biocytogen, Blackfin Bio, Cassava Sciences, China Medical Systems, Emergent Biosolutions, Esteve, Fauna Bio, Foundery Immune Studio, Galapagos, Helsinn, Ikena, Moma, Novo Nordisk, Oxford Biomedica, Sanofi, Tavros, Valo Health, Vividion, Windtree. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Astellas, Azafaros, Cour, Denali, Formycon, Johnson, Marengo, Merck, Vigeneron. Read More
