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FDA authroizes emergency use of Regeneron antibody treatment given to Trump

The Food and Drug Administration announced Saturday evening it has granted emergency use authorization for Regeneron Pharmaceuticals' antibody cocktail given to President Trump to treat his COVID-19 infection last month.

Why it matters: Regeneron's two monoclonal antibodies, casirivimab and imdevimab, are for people who tested positive for the coronavirus and "who are at high risk for progressing to severe COVID-19," including people who are 65 and older, and/or people with certain chronic illnesses, per an FDA statement.


Of note: "The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated," the FDA said.

Driving the news: A clinical trial of patients with COVID-19 found that when the two antibodies were administered together, they "were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo," the FDA said.

What to expect: Regeneron said in a statement it expects to have doses of the treatment, called REGEN-COV2, ready for some 80,000 patients by the end of November, about 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021.

Go deeper: Regeneron CEO: Trump's success with antibody cocktail is not evidence of cure

Editor's note: This a breaking news story. Please check back for updates

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House Judiciary chairman accuses Attorney General Barr of undermining democratic norms

House Judiciary Chairman Jerry Nadler (D-N.Y.) painted the integrity of the Justice Department as "more at risk than at any time in modern history" in opening remarks at a hearing for Attorney General Bill Barr Tuesday, accusing him of shielding President Trump from responsibility and eroding democratic norms.

Why it matters: The hearing, which focuses on the DOJ's alleged politicization under Barr, is the attorney general's first time appearing before the committee. Barr in his own remarks accused the committee's Democrats of trying to discredit him over his investigations into the origins of the FBI's Russia probe.

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The pandemic is getting worse again

Data: The COVID Tracking Project, state health departments; Note: Due to a database error, Missouri had a 3 day gap in reporting from Oct. 11-13; Map: Andrew Witherspoon/Axios

Every available piece of data proves it: The coronavirus pandemic is getting worse again, all across America.

The big picture: As the death toll ticks past 212,000, at a moment when containing the virus ought to be easier and more urgent than ever, we are instead giving it a bigger foothold to grow from.

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Fauci says transition delay harmful to public health as COVID-19 cases surge

NIAID Director Anthony Fauci said on CNN's "State of the Union" Sunday that President Trump's refusal to cooperate with President-elect Biden's transition team hurts public health as coronavirus cases surge across the country.

The state of play: As President Trump refuses to concede the election to President-elect Joe Biden, General Services Administration Administrator Emily Murphy has not signed documents declaring Biden the apparent winner, preventing the president-elect's agency review teams from having access to the information they need in order to get to work.

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Biden to unveil executive actions on gun violence prevention

President Biden is expected to present a series of executive actions on guns Thursday, including directing his Justice Department to tighten regulations on purchases of so-called “ghost guns."

Why it matters: The president has faced increased pressure from Democrats and gun violence prevention groups to act on the issue following a series of recent high-profile gun tragedies across the U.S.

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