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The HHS Office of Inspector General (OIG) has issued a warning to drugmakers to avoid paying kickbacks in the form of payments for speaker programs. Read More
Companies that have developed a COVID-19 vaccine that is approved in the European Union will have to submit monthly safety reports during the pandemic to the European Medicines Agency (EMA), the agency said. Read More
Hacker groups in Russia and North Korea have continue to wage cyberattacks against companies working on COVID-19 vaccines and treatments, Microsoft warned Monday, calling on governments to take action against them. Read More
A new survey shows one in five cancer patients are far less likely to participate in future clinical trials due to fear of COVID-19 exposure, raising the question of whether enrollment levels that have dropped precipitously since the beginning of the pandemic are likely to recover after the virus is controlled. Read More
President Trump said Friday that his administration is “working to secure an Emergency Use Authorization” from the FDA for Pfizer’s vaccine candidate for COVID-19 and that it will be available to the general population for free “as soon as April,” but will be withheld from states like New York whose governors have expressed qualms about a vaccine approved by the FDA under the current administration. Read More
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 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