Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alpheus, Atom, Biosplice, Cybin, Equillium, Immix, Immunitybio, Inventprise, Janssen, Longeveron, Nanology, Oncosec, Que, Redx, Resolve, Stellas, TME, Unicycive.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biomebank, Eikonoklastes, Nfl, Novartis, Oryzon, Regeneron, Xilio.
Veru Pharmaceuticals Inc.’s COVID-19 therapy VERU-111 (sabizabulin) failed to win full support from the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee, which was asked to decide about endorsing the firm’s request for an emergency use authorization to market the drug.
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.
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