Briefing documents related to the Nov. 9 meeting of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee augur well for Veru Pharmaceuticals Inc.’s request for an emergency use authorization to market VERU-111 (sabizabulin) as a treatment for COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brexogen, Inhibikase, Moderna, Sensorion, Sinovac, Verve.
The soluble form of human angiotensin-converting enzyme 2 (hsACE2) could prevent SARS-CoV-2 from binding to the host cell receptors through competitive inhibition, which may avoid viral infection. However, the relatively short half-life of the recombinant hsACE2 limits its clinical application.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Iveric, Medincell, Moderna, Sanofi, Teva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Ascentage, Bioatla, Biomind, Biontech, Laurent, NGM, Pfizer, Rain, Redhill, Vicore.
Formycon AG has published preclinical in vivo results for the development of its COVID-19 drug FYB-207. In in vivo studies, data were collected in two different models on the pharmacokinetics and efficacy of various constructs of the ACE2-Fc fusion protein, in order to select the most appropriate candidate to enter the clinic.
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