June 21 Quick Takes: NIH adds GSK- Vir mAb to COVID-19 treatment guidelines; plus Theravance, WHO, Tarsus and Amarin
NIH updated its COVID-19 treatment guidelines to recommend sotrovimab (VIR-7831) from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Vir Biotechnology Inc. (NASDAQ:VIR) to treat high-risk outpatients with mild-to-moderate COVID-19 after the partners reported confirmatory results from the Phase III COMET-ICE study showing the SARS-CoV-2 mAb significantly reduced the risk of hospitalization or death among the patient population. FDA granted the single-dose mAb emergency use authorization last month; GSK and Vir are also testing the therapy in combination with bamlanivimab to treat low-risk outpatients.
Theravance Biopharma Inc. (NASDAQ:TBPH) said its JAK inhibitor nezulcitinib (TD-0903) missed its primary endpoint of reducing the number of respiratory failure-free days vs. placebo at day 28 in a Phase II study to treat hospitalized patients with acute lung injury and impaired oxygenation from COVID-19. ...