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FDA has provided an update on the status of its inspections outside of the US in response to the COVID-19 outbreak and announced that it is postponing most foreign inspections through April, effective immediately. The Food and Drug Administration (FDA) said Tuesday that it is postponing most inspAlready a subscriber…
Valneva has announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Based on this data, the company plans to commence a Phase 3 clinical trial by the end of April 2021, subject to regulatory approval, it states in a…
SynAct Pharma has announced additional results from all treated patients in the Phase 2a clinical trial of AP1189 in Covid-19 infected patients with pulmonary insufficiency. The study was setup with part 1, where all patients were treated with AP1189, and a part 2, a randomized placebo-controlledAlready a subscriber Login You…
AZD7442, a combination of two long-acting antibodies (LAAB), reduced the risk of developing symptomatic COVID-19 by 77%, compared to placebo. The Phase III trial accrued 25 cases of symptomatic COVID-19 at the primary analysis. There were no cases of severe COVID-19 or COVID-19-related deaths in Already a subscriber Login You…
