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Russia’s sovereign wealth fund announced Wednesday that the country’s Sputnik V COVID-19 vaccine was shown to be 92 percent effective in an interim analysis from global phase 3 trials. Read More
ViiV Healthcare released interim results from a late-stage clinical trial that showed its long-acting investigational HIV treatment was 89 percent more effective in preventing infection among women than Truvada, Gilead Sciences’ daily oral pill. Read More
Canadian biopharmaceutical company Medicago has announced that its investigational COVID-19 vaccine generated “significant antibody and cellular immune responses” after two doses in all subjects in an early-stage clinical trial. Read More
Brazil’s National Agency for Sanitary Surveillance (ANVISA) has suspended Beijing, China-based Sinovac’s phase 3 trial of its COVID-19 vaccine, CoronaVac, halting the study Tuesday to evaluate a serious adverse event that occurred. Read More
Almost two-thirds of participants in clinical trials to support U.S. drug approvals from 2015 to 2019 were outside the U.S., the FDA’s Center for Drug Evaluation and Research (CDER) said in a new report unveiled yesterday. Read More
As part of its ongoing efforts to make clinical trials more representative of the population, the FDA yesterday issued a final guidance on what sponsors should do to make trials more accessible and appealing to under-represented racial, ethnic, gender and age groups. Read More
The FDA has issued an Emergency Use Authorization (EUA) for Eli Lilly’s monoclonal antibody treatment bamlanivimab (LY-CoV555), clearing the drug for use in high-risk patients with mild-to-moderate COVID-19 who don’t need hospitalization or oxygen. Read More
Pfizer and BioNTech have pulled ahead to become the frontrunners in the race for a COVID-19 vaccine, announcing that the first interim analysis from their late-stage trial showed the candidate was more than 90 percent effective. Read More
One arm of the UK’s RECOVERY trial evaluating potential COVID-19 treatments is including aspirin in combination with the drugs being evaluated. Read More