Gene therapy developer Kate Therapeutics Inc. (KateTx), which is developing next-generation adeno-associated virus (AAV) vectors that target skeletal and cardiac muscle, has unveiled $51 million series A round and a licensing deal with Astellas Pharma Inc. Read More
Less than two years ago, in October 2021, a group of investors bid at auction on a promising monoclonal antibody to treat asthma, chronic rhinosinusitis and other inflammatory conditions, winning the asset known as UPB-101, the sole focus of the then-newly launched Upstream Bio Inc. Read More
Following strong phase I study data in malignant melanoma released a year ago, Ultimovacs ASA’s lead candidate, UV-1, stumbled in the phase II trial, which did not meet the primary endpoint of progression-free survival in second-line treatment of malignant pleural mesothelioma. Read More
The U.S. FDA’s Antimicrobial Drugs Advisory Committee voted unanimously, 21-0, June 8 in support of Astrazeneca plc’s nirsevimab as a one-dose prophylactic for infants born during or entering their first respiratory syncytial virus (RSV) season. Read More
China’s NMPA granted a green light to China Medical System Holdings Ltd.’s tildrakizumab injection to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sold under the brand name Ilumetri, tildrakizumab is a humanized lgG1/κ monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor to block the release of pro-inflammatory cytokines and chemokines. Read More
Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Amgen, Ascentage, Beyondspring, Bicara, Cohbar, Immvira, Jazz, Kite, Merck & Co., Moderna, Morphogenesis, Nascent, Neximmune, Nkgen, Oncoinvent, Oncolytics, Portage, Precigen, Promontory, Puma, Replimune, Servier, Sorrento, Sutro, Zentalis, Zymeworks. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baudax, Bioinvent, Bridgebio, Coya, Durect, Emergex, Fibrogen, Fluoguide, Lixte, Ocular, Oncternal, Replimune, Rigel, Ventyx, Vera, Vistagen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capricor, Dtx, Itabmed, Janssen, Legend, Med-Life, Merz, Onquality. Read More