U.S. medical device maker Becton Dickinson and Co said on Wednesday its COVID-19 antigen test kit met the requirements for a launch in Europe. The approval comes as the region struggles with insufficient COVID-19 tests and long waits for results, while it battles a resurgence in infections. The test, which can be performed in a…

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For years, researchers have called out a glaring gap in many clinical trials: Despite having far higher rates of many diseases, older adults are largely excluded from studies testing new therapies that might help them. For how extensively experts have studied the issue of age disparities, though, it remains a significant problem — and one…

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The next three months will be among the most consequential in the Food and Drug Administration’s modern history. This fall, at least two of the leading coronavirus vaccine makers could seek emergency approvals, setting up what will be a series of momentous decisions for the regulator. The FDA will face immense pressure to clear a…

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Dive Brief: The Trump administration on Monday announced that 6.5 million Abbott BinaxNOW Ag Card rapid tests will be delivered to states this week to help governors reopen their economies and schools.  Abbott’s COVID-19 point-of-care antigen test, which costs $5 and delivers results in 15 minutes, was granted an FDA emergency use authorization on Aug. 26. A day later, HHS awarded Abbott a…

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Pfizer CEO Albert Bourla and his vaccine partner BioNTech have said the companies expect phase 3 data by the end of October—and that an FDA application could soon follow. But more than 60 researchers and bioethicists urged the partners to wait for more safety data before submitting their shot for a green light, Bloomberg reports. The experts called on Pfizer…

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President Donald Trump announced Monday that the federal government will begin distributing millions of rapid coronavirus tests to states this week and urged governors to use them to reopen schools for students in kindergarten through 12th grade. The move to vastly expand U.S. testing comes as confirmed new COVID-19 cases remain elevated at more than…

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France, Germany and UK among more than 60 countries promising to put wildlife and climate at heart of post-Covid recovery plans World leaders have pledged to clamp down on pollution, embrace sustainable economic systems and eliminate the dumping of plastic waste in oceans by the middle of the century as part of “meaningful action” to…

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WASHINGTON — When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.” The initiative — to accelerate the development of Covid-19 vaccines and therapeutics — lacks the scale, and the degree of secrecy, of the effort to build the atomic bomb. But Operation…

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The World Health Organization announced Monday that it and leading partners have agreed to a plan to roll out 120 million rapid-diagnostic tests for the coronavirus to help lower- and middle-income countries make up ground in a testing gap with richer countries — even if it’s not fully funded yet. At $5 apiece, the antigen-based…

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