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New Drug Designations - September 2023

New Drug Designations – September 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, and China. This month’s report includes 10 biological drugs, 15 small molecules, 5 cell and gene therapies, 4 devices, 1 vaccine and 1 microbiota MicuRx’ Contezolid and Contezolid acefosamil, focused on the treatment of Diabetic…

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VIEWPOINTS_Simon Portsmouth_2023

Simon Portsmouth Shares Insights from P-III Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection

Shots:Simon spoke about the enrollment of the first participant in Japan in the P-III (SCORPIO-PEP) study to evaluate the safety and efficacy of Ensitrelvir for the prevention of symptomatic SARS-CoV-2 infectionHe mentioned how this study will supplement data from the pivotal SCORPIO-SR trial's P-III segment which showed ensitrelvir's effectiveness in treating mild-to-moderate COVID-19…

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