Vida Ventures, the venture capital firm co-founded by CAR T pioneer Arie Belldegrun, has closed an oversubscribed $825 million fund, bringing the total amount of assets under management to more than $1.7 billion. Read More
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans. Read More
Accelerated approval based on a phase II single-arm trial doesn’t appear to be in the cards for Incyte Corp.’s retifanlimab as a second-line treatment for advanced or metastatic squamous cell anal cancer (SCAC). Following the lead of FDA reviewers June 24, the agency’s Oncologic Drugs Advisory Committee (ODAC) voted 13-4 to recommend that the agency defer its approval decision until more data are available from POD1UM-303, a confirmatory trial in platinum-naïve advanced SCAC. Read More
Wall Street must wait a while longer to find out if Gilead Sciences Inc. will exercise its $275 million option for Arcus Biosciences Inc.’s TIGIT binder, domvanalimab. Meanwhile, investors took heart from an optimistic – albeit vague – interim report on the phase II ARC-7 trial. Read More
LONDON – New data from a randomized community study involving more than half a million people has shown that of 92,116 who had symptomatic COVID-19, 38% were still reporting symptoms 12 weeks later. Read More
PERTH, Australia – Starpharma Holdings Ltd. is pausing sales of its antiviral nasal spray, Viraleze (SPL-7013), in the U.K. after its retail partner, Lloydspharmacy, received a letter from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) related to promotional claims made about the antiviral with respect to SARS-CoV-2 and COVID-19. Read More
Medigen Vaccine Biologics Corp. released results from a phase III trial of its enterovirus 71 (EV71) vaccine that showed efficacy of 100% against a virus that causes hand, foot and mouth disease and continues to emerge on a regular basis across Asia. Read More
Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes. Read More
TORONTO – Health Canada has proposed a single regulatory framework for medical device and drug clinical trials after broad industry consultation and a hard line drawn by the COVID-19 pandemic for a more streamlined system. Read More
Biopharmas raising money in public or private financings, including: Acumen, Aerovate, Arya, Gliknik, Lyndra, Karyopharm, Monte Rosa, Phoenix Pharmalabs, Portage, Triastek. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Clovis, Editas, Genprex, Gilead, GT, Immunicum, Incarda, Karuna, Medicenna, Nasus, Novartis, Praxis, Seal Rock, Vifor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4D, Abbvie, Betterlife, Bio-Techne, Biontech, BMS, Catamaran, Cobra, Cognate, Charles River, Combigene, Ectin, Eqrx, Exscientia, Foundation Medicine, Gynica, Link Medical, Macrophage, Mydecine, Mylan, Navidea, Poxel, Prothena, PTC, Roche, Takara, Teneobio, Tikun, Viatis and Zenith Epigenetics. Read More
