Phase III
Many companies appear to be getting their clinical trial news updated ahead of the holidays. Here’s a look.
Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study assessing the monoclonal antibody VIR-7831 as a potential treatment of hospitalized adults diagnosed with COVID-19.
It seems like history is repeating itself from just a week ago. Yesterday, the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant Moderna’s COVID-19 vaccine emergency use authorization (EUA).
Shares of Mesoblast Limited are down more than 30% in premarket trading following the company’s disappointing announcement late Thursday regarding its stem-cell therapy trial in ventilator-dependent patients with COVID-19 patients who have moderate to severe acute respiratory distress syndrome.
It’s been a busy day so far for biopharma news and updates. Read on for more.
On Tuesday, Novartis announced the first interpretable results from its Phase III KESTREL study of humanized single-chain antibody fragment (scFv) Beovu, demonstrating significant improvement in central subfield thickness in Diabetic Macular Edema.
Many drug makers are investing in new science and hope to develop new therapeutics that address autoimmune disease. BioSpace has captured some key efforts.
All eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
Germany’s CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19.
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