The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dascena, Labcorp, OralDNA Labs.
Humanigen Inc. reported progress in COVID-19 treatment by deploying a drug candidate, lenzilumab, that was created to fight cytokine storms in CAR T patients. The drug is partnered for the latter with Gilead Sciences Inc., which rolled out pandemic news of its own related to the investigational broad-spectrum antiviral Veklury (remdesivir).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biomarin, Bluebird, Innovation, Kyowa Kirin, Mesoblast, Optibiotix Health, Ovoca, Pharmacyte, Sanofi, Seed Health.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aduro, Akorn, Allele, Chiesi Global Rare Diseases, Chinook, Cognate, Fibrogenesis, Innate Immune, Jaguar, Lakes, Novus, PDL, Protalix, R4D Biotech, Scancell, Teva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aiviva, Algernon, Astrazeneca, Cytokinetics, Epygenix, Kyowa, Mei, Otonomy, RVL, Synthetic Biologics, Xencor.