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The UK has authorized the use of the corticosteroid dexamethasone to reduce the risk of death in COVID-19 patients requiring ventilation or oxygen. Read More
A majority of European clinical trials of COVID-19 drugs are being run by universities and companies who either lack experience or have a poor track record in uploading their results to the EU’s trial database, which could lead to wasted research, according to a new report. Read More
A small study of early COVID-19 patients in Italy showed Roche’s Actemra (tocilizumab) provided no benefit, the Italian Medicines Agency (AIFA) said. Read More
The FDA has been forced to streamline its guidance development process during the COVID-19 pandemic, and the change is likely to shape its approach beyond the pandemic, says Center for Biologics Evaluation and Research (CBER) Director Peter Marks. Read More
“It is not reasonable to believe that the test may be effective in detecting antibodies against SARS-CoV-2 or that the known and potential benefits of the test outweigh the known and potential risks of the test,” the agency said. Read More
The WHO said this decision does not apply to the use or evaluation of hydroxychloroquine as a prophylaxis treatment in people exposed to COVID-19. Read More
The European Union announced a COVID-19 vaccine strategy yesterday to deliver a vaccine within 12 to 18 months, or possibly sooner, and to procure an adequate supply for EU members. Read More
Sponsors of trials impacted by the COVID-19 pandemic have several statistical analysis options for mitigating the effect of missing data, according to the FDA. Read More
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