Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bonalive, Evoendo, Novacyt, Oncimmune.
As the Biden administration continues to play musical chairs with key U.S. federal health leadership positions, its latest move is naming Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisers on Science and Technology.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Center for Pain & Stress Research, Esaote North America.
Studies published this week have introduced a consensus-based definition of long COVID-19 in children and young persons, narrowing its prevalence estimates, which have been wildly divergent. Long COVID rates for adults are still unclear, but a recent meta-analysis estimated that between one third and two thirds of adult COVID-19 patients who had severe acute disease develop symptoms of long COVID.
While a number of U.S. cities and towns have been conducting wastewater testing for the SARS-CoV-2 virus for some time, the CDC has finally established a dashboard for reporting the results of this surveillance. While the resulting data may be useful in the current pandemic for allocation of resources, the establishment of a network of wastewater surveillance instruments can also be instrumental in future public health efforts, such as tracking foodborne infections and detecting the emergence of new antibiotic-resistant pathogens.
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
Russia’s Ministry of Health is looking to extend its role on the global stage. Over the next few months, the ministry, along with other regulatory agencies in Russia, said it plans to start the accreditation process of coming into compliance with World Health Organization (WHO) standards.
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
LONDON – The first human challenge study of SARS-CoV-2 infection has reported initial results, showing it is safe to infect healthy volunteers with the virus in controlled conditions, and paving the way for the model to be used to accelerate clinical trials of COVID-19 vaccines, antivirals and diagnostics.
The availability of rapid antigen tests for the COVID-19 pandemic has been far short of ideal in recent weeks despite a recent order by the Biden administration for half a billion tests. The question of whether additional federal dollars are forthcoming for additional tests is up in the air, however, due to congressional concerns that there is roughly $800 million in unspent federal dollars, a signal that any additional monies might not be made available any time in the near term.
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