There are now two FDA-backed monoclonal antibody COVID-19 treatments after the agency granted Glaxosmithkline plc (GSK) emergency use authorization (EUA) for single-dose sotrovimab to treat mild to moderate COVID-19 in adults and children as young as 12. Vir Biotechnology Inc. collaborated on the program. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 May 27 that the benefits of Provention Bio Inc.’s teplizumab outweighed its risks, but the vote was not a ringing endorsement of the anti-CD3 monoclonal antibody biologic that could be the first disease-modifying treatment for people at risk of developing type 1 diabetes (T1D). Read More
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19. Read More
Locust Walk Acquisition Corp. CEO and biotech veteran Chris Ehrlich said his firm sifted through more than 90 prospects before setting on a merger with Effector Therapeutics Inc., focused on selective translation regulation inhibitors (STRIs) in cancer. Read More
LONDON – Pulmocide Ltd. has closed a $92 million oversubscribed series C, providing the means to take its inhaled antifungal drug, PC-945, through a global phase III registration study in invasive pulmonary aspergillosis. Read More
The Research to Accelerate Cures and Equity for Children Act is leading to deep changes in pediatric cancer research. Passed in 2017 and fully implemented in 2020, the RACE Act requires companies to investigate targeted drugs for adult cancers in pediatric cancers as well “when the molecular target of the drugs are substantially related to a pediatric cancer.” Read More
Engine Biosciences Pte. Ltd., a Singapore and Silicon Valley-based company using machine learning, combinatorial genetics and other technologies to hasten the discovery of gene interactions and biological networks underlying disease, has raised $43 million in series A financing. Polaris Partners led the round, which the company said would help it expand its portfolio of precision oncology therapeutics, prepare for its first clinical programs, and scale its technology platform. Read More
Biopharmas raising money in public or private financings, including: Acurx, Day One, Frazier, HCW, Mirecule, Oisín, Reviva, Sparta Healthcare. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC, Aim, Astrazeneca, Bavarian Nordic, Boan, Cancervax, Dicerna, Dynavax, Eloxx, Lilly, Medisynergics, Metagenomi, Oncorus, Smoore, Onk, Pfizer, Pharmather, Recce, Snipr, UCLA, University Hospital Zurich. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioinvent, Dicerna, Eli Lilly, Emmaus, Foresee, Gannex, GSK, Hightide, Intercept, J&J, Legend, Myovant, Ocugen, Pfizer, Seelos, Tarus, Transgene, Vir. Read More
