An antibody that protects babies against respiratory syncytial virus (RSV) from Astrazeneca Ltd. and Sanofi SA was among a string of recommendations from the EMA’s Committee for Medicinal Products for Human Use, paving the way for approval within the next few months and a potential launch in 2023. Read More
Bearish investors dwelling on a single grade 4 liver enzyme elevation seemed to be the cause for Intellia Therapeutics Inc.’s sinking stock Sept. 16, despite the company reporting impressive, though early stage, data for its leading systemically administered CRISPR candidates targeting hereditary angioedema (HAE) and amyloid transthyretin (ATTR) amyloidosis. Read More
A prespecified interim analysis revealed that Astrazeneca plc’s oral factor D inhibitor danicopan met the primary endpoint of a phase III trial as an add-on therapy for patients with paroxysmal nocturnal hemoglobinuria (PNH) who were also taking a C5 inhibitor, but who still experienced extravascular hemolysis. Read More
What was once effective is now a non-starter. Newly updated guidelines from the World Health Organization (WHO) caution against using the COVID-19 treatments sotrovimab, from GSK plc and Vir Biotechnology Inc., and Regen-Cov (casirivimab + imdevimab), from Regeneron Pharmaceuticals Inc. Omicron, the group said, has rendered the monoclonal antibodies ineffective. Read More
Sex differences at the cellular level could explain why men respond less well to glioblastoma (GBM) treatments, according to a study led by the Washington University School of Medicine in St. Louis (WUSTL). The researchers found that male and female GBM tumor cells had different metabolic needs. GBM cells from male surgical samples absorbed more glutamine and had different nutritional preferences for amino acids. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Alnylam, Ascletis, Biojiva, Brainstorm Cell, Bristol Myers Squibb, Celsion, Curevo, Eloxx, Excision, Inhibikase, Navidea, Omeros, Pfizer, Regeneron. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cage, Cardurion, Enzolytics, Imara, J Ints, Peptistar, Pharvaris, Quince, Sorrento, Syros, Tagcyx, Twist, and Tyme. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aro, Candel, Inversago, Jasper, Kymera, Lipocine, Mallinckrodt. Read More
