COVID-19 vaccines: Global regulators debate phase 3 data requirements
Global regulators have held a workshop designed to nail down the data they will require of companies developing vaccines against COVID-19.
Global regulators have held a workshop designed to nail down the data they will require of companies developing vaccines against COVID-19.
Equillium, Inc., announced that as reported by its partner, Biocon Limited, a clinical trial conducted in India by Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized… read more.
The European Medicines Agency will welcome a new Executive Director by the end of 2020. The change comes as the EU drug watchdog’s current chief, Guido Rasi, is… read more.
Verrica Pharmaceuticals Inc. announced that the Company received a letter from the FDA as part of the FDA’s ongoing review of the Company’s New Drug Application (NDA) for… read more.
Gilead Sciences, Inc. announced additional data on remdesivir, an investigational antiviral for the treatment of COVID-19, adding to the available body of knowledge on treatment outcomes with remdesivir…. read more.
Aldeyra Therapeutics, Inc. announced development plans to support a New Drug Application (NDA) for the novel investigational reactive aldehyde species (RASP) inhibitor reproxalap in dry eye disease …. read more.
BD (Becton, Dickinson and Company) announced that the FDA granted Emergency Use Authorization (EUA) for a rapid, point-of-care, SARS-CoV-2 diagnostic test for use with its broadly available BD… read more.
Regeneron Pharmaceuticals, Inc. announced the initiation of late-stage clinical trials evaluating REGN-COV2, Regeneron’s investigational double antibody cocktail for the treatment and prevention of COVID-19 . A Phase III… read more.
Gilead Sciences, Inc.announced that the European Commission has granted conditional marketing authorization for Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional… read more.
Sanofi and Regeneron Pharmaceuticals, Inc. announced that the . Phase III trial of Kevzara (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary… read more.
Pfizer and BioNTech announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT 162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2. The BNT… read more.
Inovio has announced positive interim clinical data of INO 4800 vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase I clinical trial cohorts. In addition, INO… read more.
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