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Pfizer and BioNTech, current frontrunners in the race for an approved COVID-19 vaccine, have finalized an agreement with the European Commission to supply 300 million doses of their vaccine starting by year’s end — but the vaccine’s distribution is expected to face serious challenges worldwide because it must be stored at super-cold temperatures. Read More
Efficacy questions are swirling about the 700-mg dose of Eli Lilly’s COVID-19 antibody treatment bamlanivimab that just this week received Emergency Use Authorization (EUA) from the FDA. Read More
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