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https://s3.us-west-1.wasabisys.com/virusreports/2020/05/cropped-virus-favicon-32x32.png authorizes Archives - Virus Reports https://virusreports.net/tag/authorizes/ 32 32 Cuomo authorizes New York schools to reopen amid coronavirus pandemic https://virusreports.net/cuomo-authorizes-new-york-schools-to-reopen-amid-coronavirus-pandemic/ https://virusreports.net/cuomo-authorizes-new-york-schools-to-reopen-amid-coronavirus-pandemic/#respond Fri, 07 Aug 2020 16:21:50 +0000 https://virusreports.net/cuomo-authorizes-new-york-schools-to-reopen-amid-coronavirus-pandemic/ New York Gov. Andrew Cuomo announced Friday that schools across the state are "authorized to open" for the 2020 school year amid the coronavirus pandemic."Every region is well below our COVID infection limit, therefore all school districts are authorized to open," Cuomo tweeted Friday. "If the infection rate spikes, the guidance will change accordingly. School districts…

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New York Gov. Andrew Cuomo announced Friday that schools across the state are “authorized to open” for the 2020 school year amid the coronavirus pandemic.

“Every region is well below our COVID infection limit, therefore all school districts are authorized to open,” Cuomo tweeted Friday. “If the infection rate spikes, the guidance will change accordingly. School districts are required to submit plans to NYS for review.”

During a news conference Thursday, Cuomo said it was important that parents and teachers be included in the decision-making.

CUOMO SAYS SCHOOLS IN NEW YORK CAN REOPEN IF REGION IS IN ‘PHASE 4’

“Parents have to be included and believe the plan makes sense,” he said. “Teachers have to be included and believe the plan makes sense.”

He added: “They are the ultimate determination.”

“If a teacher doesn’t show up, you can’t open the class,” he continued. “If a parent doesn’t send their child there’s no child to educate.”

Cuomo announced last month that schools can only begin in-person learning in the state once the region has entered its “Phase 4”—its final phase—of reopening. Cuomo also said that the daily infection rate in that region needed to remain at 5 percent or lower over a 14-day average.

Cuomo teased last month that his administration would make the determination in the first week of August and would monitor all numbers between the time the decision to reopen a school is made and the first day of school, while warning that if an infection rate in the region goes over 9 percent on a seven-day average, the decision to reopen schools will likely be reversed.

Cuomo had asked last month that all school districts and local governments “submit a plan” to his administration to be reviewed.

One plan submitted to Cuomo’s office was from New York City Mayor Bill de Blasio, who suggested that students would learn on a “blended” schedule and be limited to a maximum of three days in the classroom, while engaging in remote learning for the remainder of the week.

NYC PUBLIC SCHOOLS TO OPEN ON ‘BLENDED, SPLIT-SCHEDULE’ MODEL, WITH PART-TIME IN PERSON, PART-TIME REMOTE LEARNING

The de Blasio administration also said that they would send “schedules” to families in August so that parents “will know which days the students are expected in person.”

Classrooms will only hold between nine and 12 students for in-person learning, city officials said Wednesday, adding that the schools will be working on additional models to determine if some students need more in-person learning than others.

This is a developing story; check back for updates.

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Senate authorizes subpoena in Hunter Biden probe https://virusreports.net/senate-authorizes-subpoena-in-hunter-biden-probe/ https://virusreports.net/senate-authorizes-subpoena-in-hunter-biden-probe/#respond Wed, 20 May 2020 18:21:10 +0000 https://virusreports.net/senate-authorizes-subpoena-in-hunter-biden-probe/ A Senate committee on Wednesday voted to authorize a subpoena as it probes the business ties of Hunter Biden, the son of likely Democratic presidential nominee Joseph R. Biden. The 8-6 party-line vote in the Senate Homeland Security and Governmental Affairs committee gives Chairman Ron Johnson the authority to subpoena Blue Star Strategies, a PR…

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A Senate committee on Wednesday voted to authorize a subpoena as it probes the business ties of Hunter Biden, the son of likely Democratic presidential nominee Joseph R. Biden.

The 8-6 party-line vote in the Senate Homeland Security and Governmental Affairs committee gives Chairman Ron Johnson the authority to subpoena Blue Star Strategies, a PR firm that has done work for the Ukrainian energy company Burisma.

Mr. Johnson said if there’s no wrongdoing there’s nothing to fear in moving forward, while Democrats have said Republicans are grasping at straws with an election-year move to dent the presidential prospects of Mr. Biden, the likely Democratic nominee.

Blue Star CEO Karen Tramontaro said in a letter to Mr. Johnson on Wednesday that they have been cooperating with committee requests for documents and are “puzzled” on why the committee was proceeding with a subpoena.

A committee spokesman said the company had dragged its feet on the matter for months and only picked up the pace after lawmakers announced plans for the vote.

President Trump and his allies have raised questions about Hunter Biden and the sweetheart gig he had on the board of Burisma while his father was vice president.

The elder Mr. Biden has bragged about threatening to withhold $1 billion in U.S. loan guarantees from Ukraine if its leaders did not get rid of a top prosecutor in the country who reportedly was eyeing corruption in the country, including at Burisma.

The Democrat-led House voted to impeach Mr. Trump last year, saying the president abused his power in trying to strong-arm Ukraine into digging up dirt on the Bidens. The GOP-controlled Senate voted to acquit Mr. Trump earlier this year.

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FDA authorizes emergency use of coronavirus drug remdesivir https://virusreports.net/fda-authorizes-emergency-use-of-coronavirus-drug-remdesivir/ https://virusreports.net/fda-authorizes-emergency-use-of-coronavirus-drug-remdesivir/#respond Sat, 02 May 2020 16:59:04 +0000 https://virusreports.net/fda-authorizes-emergency-use-of-coronavirus-drug-remdesivir/ The FDA has issued emergency authorizations for a range of Covid-19 tests as well as hydroxychloroquine | Jacquelyn Martin, File/AP Photo The Food and Drug Administration on Friday issued an emergency-use authorization for remdesivir in a bid to help patients get quicker access to the first antiviral to show promise against Covid-19 infection. The authorization…

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The FDA has issued emergency authorizations for a range of Covid-19 tests as well as hydroxychloroquine | Jacquelyn Martin, File/AP Photo

The Food and Drug Administration on Friday issued an emergency-use authorization for remdesivir in a bid to help patients get quicker access to the first antiviral to show promise against Covid-19 infection.

The authorization comes two days after data from a government trial suggested the experimental drug could help patients recover faster and might reduce death rates compared with a placebo. The nation’s top infectious disease doctor, Anthony Fauci, said the results make remdesivir the new standard of care as researchers continue to develop more effective options.

But he also cautioned that, while the results were encouraging, they represented an early step toward finding effective coronavirus treatments — much as the drug AZT represented the first hope for AIDS patients in the 1980s, but was later supplanted by much more effective combination therapies.

An emergency-use authorization is not a full approval — the drug must undergo further review — but it allows doctors to use remdesivir outside clinical trials during the pandemic. FDA has issued emergency authorizations for a range of Covid-19 tests as well as for hydroxychloroquine, a malaria medicine with limited evidence suggesting it can fight the coronavirus. President Donald Trump has called remdesivir a “building block” in progress toward fighting the coronavirus.

The EUA allows the drug to be administered to patients with confirmed or suspected coronavirus infections.

“The statutory standard for EUA is very weak,” said Holly Fernandez Lynch, a medical ethics professor at the Perelman School of Medicine at the University of Pennsylvania. “If it was met for [hydroxychloroquine], which was questionable to be honest, it was clearly met here. It’s just ‘may be effective’ based on available evidence.”

Fernandez Lynch said she was “a little surprised” that the EUA applied to patients whose coronavirus diagnosis had not been confirmed by testing.

The full findings from the federal trial of the drug, sponsored by the National Institute of Allergy and Infectious Diseases, have not been publicly released.

Gilead has said it will donate the first 1.5 million doses of remdesivir, which should be enough for about 140,000 Covid-19 patients. Questions remain on how much remdesivir will eventually cost.

Democratic Reps. Lloyd Doggett of Texas and Rosa DeLauro of Connecticut recently questioned Health and Human Services Secretary Alex Azar on how much the federal government has spent on the research and development of remdesivir.

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FDA Authorizes Gilead’s Remdesivir for COVID-19 https://virusreports.net/fda-authorizes-gileads-remdesivir-for-covid-19/ https://virusreports.net/fda-authorizes-gileads-remdesivir-for-covid-19/#respond Sat, 02 May 2020 01:48:20 +0000 https://virusreports.net/fda-authorizes-gileads-remdesivir-for-covid-19/ A temporary authorization for emergency use during the pandemic follows two successful clinical trials. The U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to Gilead Sciences (NASDAQ:GILD) to use its investigational antiviral drug remdesivir to treat COVID-19. President Trump made the announcement in the Oval Office along with Gilead Chief Executive Officer…

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A temporary authorization for emergency use during the pandemic follows two successful clinical trials.

Jim Crumly

The U.S. Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to Gilead Sciences (NASDAQ:GILD) to use its investigational antiviral drug remdesivir to treat COVID-19. President Trump made the announcement in the Oval Office along with Gilead Chief Executive Officer Daniel O’Day, and the FDA released a letter confirming the authorization.

Remdesivir hasn’t been formally approved to treat any disease, but today’s action by the FDA authorizes it for temporary use during the pandemic to treat hospitalized patients with severe COVID-19.

Vials of drugs on a manufacturing line

Image source: Getty Images.

The FDA decision was based on a review of top-line data from two clinical trials. In a placebo-controlled phase 3 trial  conducted by the National Institute for Allergy and Infectious Diseases, 1,063 critically ill patients receiving remdesivir had an average recovery time of 11 days, compared with 15 days in the placebo group. Those receiving the drug also had a lower mortality rate, although the mortality result was not proven with statistical significance. Patients in Gilead’s own Simple-1 trial showed improvement as well, but that trial was for comparing two different durations of treatment and wasn’t placebo-controlled.

Gilead is donating its entire current supply of the drug at no cost, which amounts to enough to treat 140,000 patients, assuming a course of treatment lasting 10 days. The biotech company is racing to ramp up manufacturing capacity and has set a goal of producing 500,000 treatment courses by October and a million by December. The Simple-1 study, though, suggested that a 5-day course of treatment produced similar results as a 10-day course, so Gilead now believes it will be able to treat far more patients than it thought when it set those goals.


Jim Crumly owns shares of Gilead Sciences. The Motley Fool owns shares of and recommends Gilead Sciences. The Motley Fool has a disclosure policy.

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FDA authorizes first at-home test kit for COVID-19 https://virusreports.net/fda-authorizes-first-at-home-test-kit-for-covid-19/ https://virusreports.net/fda-authorizes-first-at-home-test-kit-for-covid-19/#respond Wed, 22 Apr 2020 14:25:20 +0000 https://virusreports.net/fda-authorizes-first-at-home-test-kit-for-covid-19/ Fox News Back to Top ©2020 FOX News Network, LLC. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed. All market data delayed 20 minutes. New Privacy Policy - New Terms of Use (What's New) - FAQ

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FDA authorizes first at-home coronavirus test https://virusreports.net/fda-authorizes-first-at-home-coronavirus-test/ https://virusreports.net/fda-authorizes-first-at-home-coronavirus-test/#respond Tue, 21 Apr 2020 14:25:34 +0000 https://virusreports.net/fda-authorizes-first-at-home-coronavirus-test/ Get all the latest news on coronavirus and more delivered daily to your inbox. Sign up here.The FDA has authorized the first diagnostic test with a home collection option for COVID-19, the disease caused by coronavirus.In a statement released Tuesday, the FDA said that it had reissued an Emergency Use Authorization for LabCorp to COVID-19 RT-PCR…

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The FDA has authorized the first diagnostic test with a home collection option for COVID-19, the disease caused by coronavirus.

In a statement released Tuesday, the FDA said that it had reissued an Emergency Use Authorization for LabCorp to COVID-19 RT-PCR Test to permit testing of samples that were self-collected by patients at home using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit.

“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Dr. Stephen Hahn.

CORONAVIRUS OUTBREAK LEADS TO NASAL SWABS BEING 3D-PRINTED

Coronavirus testing is in the spotlight as America fights to contain the outbreak. Data compiled by the CDC indicate that, since the start of April, up to 140,000 coronavirus tests a day have been conducted in the U.S.

“This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline,” explained the FDA, in its statement. “Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.”

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As of Tuesday morning, more than 2.49 million coronavirus cases have been diagnosed worldwide, at least 787,960 of which are in the U.S. The disease has accounted for at least 171,255 deaths around the world, including at least 42,364 people in the U.S.

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