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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
A United Nations-backed agency announced yesterday that 18 generic drug manufacturers have pledged to cooperate to speed up access to COVID-19 treatments for low- and middle-income countries. 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
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