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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 Senate Appropriations Committee has released the draft of a bill that would grant the FDA $3.2 billion in fiscal 2021 funding — an amount that mirrors what the House allocated in July and is in line with the Trump administration’s budget request for the agency. Read More
Democrats in both the House and Senate have penned letters to the Department of Justice protesting its $8.3 billion settlement with Purdue Pharma that would see the beleaguered opioid maker become a public benefit company as it emerges from bankruptcy over its role in the opioid crisis. 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
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
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