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Despite the FDA’s recent approval, international skepticism persists over the use of Gilead Sciences’ remdesivir for treating COVID-19 patients. Another prominent group, the European Society of Intensive Care Medicine, is now advising clinicians that the drug should not be routinely used for treating COVID-19 patients Read More
A small U.S. study found that the anti-depressant, fluvoxamine, may have potential as a treatment of COVID-19 patients with breathing problems. Read More
Moderna announced last week that it has seen an increased rate of COVID-19 cases across sites in its late-stage vaccine trial and, as a result, its first interim analysis will include significantly more coronavirus cases than anticipated. Read More
The Infectious Diseases Society of America (IDSA) said that it is conducting its own evaluation of the data that led to the FDA’s Emergency Use Authorization (EUA) for the 700-mg dose of Eli Lilly’s COVID-19 antibody treatment bamlanivimab. Read More
Research into COVID-19 therapeutics has faced a number of problems during the pandemic that ought to be learned from, including underpowered trials, a lack of coordination and enrollment issues, according to Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, who is currently on leave heading the therapeutics arm of the government’s Operation Warp Speed program. Read More
Mallinckrodt has launched a retrospective study to collect real-world data on its nitric gas inhaled therapy, INOmax, as a potential treatment for COVID-19 patients with respiratory problems. Read More
AstraZeneca has announced that its blood cancer drug, Calquence (acalabrutinib), failed to reduce COVID-19-linked respiratory failure or death in two clinical trials. Read More
Novavax published its entire $1.6 billion Operation Warp Speed vaccine contract in a Securities and Exchange Commission (SEC) filing this week, ending speculation about the details. Read More
The World Health Organization (WHO)’s ACT-Accelerator program is focusing on increasing global access to dexamethasone and monoclonal antibodies and has built up significant vaccine manufacturing capabilities, but it has zero plans for facilitating access to the only FDA-approved COVID-19 treatment, remdesivir. Read More