Gilead's remdesivir gets U.S. FDA approval for hospitalized COVID-19 patients

10/23/2020 5:15:00 AM

The U.S. Food and Drug Administration approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

The U.S. Food and Drug Administration approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States. Remdesivir, given intravenously, was one of the drugs used to treat U.S. President Donald Trump during his bout with …

RemdesivirRemdesivirremdesivirRemdesivirhas become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival. The drug also has not been proven to significantly help moderately-ill patients, and many doctors remain wary of using it in patients with less severe illness.

remdesivir‘s benefits.Also on Thursday, the FDA issued a new emergency use authorization for

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Gilead’s remdesivir gets US FDA approval for use in hospitalized COVID-19 patientsThe U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc&039;s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug

Outbound travelers no longer need to test negative for COVID-19: PalaceSa ibang mga bansa d gaanong k complicated pag local air travel pero pag galing foreign n bansa at papasok s country nla talagang quarantine ang bagsak wid full food ayuda at mala hotel n akomodation bago k papayagan tumuloy s kanilang bansa. Cguro iba ibang peg lng talagesh Sna for local travel less restrictions n as long as proper protective protocols are strictly implemented pra makabawi ang airline industry at matigil n yung lay offs ng mga airline workers at makakatulong n rin buhayin ang local tourism. Pag me trabaho ang mg tao less complain Ahmm.. Ask ko lang po paano naman po pag yung mga taong papasok ng bansa po ng pilipinas Papaano po yung mga Galing Sa United states of america (katulad ko po) pauwi sa pilipinas Sana ma pansin niyo po tanong ko po.. God Bless po😇

Biden warns of 'dark winter' of COVID-19 in final Trump debateJoe is so poor in dabate... He sounds like a typical and traditional politician... Trump will lose this election big time! Can't believe some Filipinos supports this racist president that compared himself to be the least one 'since or maybe' Abraham Lincoln. 🤡 haiz eto na Naman like rapplerdotcom sp bias of JoeBiden and also the party TheDemocrats since 44th BarackObama days 🤔

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The U.Reuters / 04:43 AM October 23, 2020 An ampule of Gilead Sciences COVID-19 antiviral remdesivir is pictured during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues.MANILA - Travelers headed abroad are no longer required to test negative for the novel coronavirus before their trip, Malacañang said Friday, as authorities sought to boost the pandemic-battered economy.WASHINGTON - Joe Biden on Thursday assailed President Donald Trump as having no plan to stop a "dark winter" of coronavirus deaths as they sparred in their last head-to-head clash 12 days before the election.

S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.S. Remdesivir , given intravenously, was one of the drugs used to treat U. "Wala na pong antigen requirement sa lahat po na bibiyahe sa labas ng bansa," Roque added in a Laging Handa public briefing.S. Gilead said it is currently meeting real-time demand for remdesivir, which is sold under the brand name Veklury, in the United States and anticipates meeting global demand by the end of October. President Donald Trump during his bout with COVID-19. "We're about to go into a dark winter," he said.

The FDA’s formal approval comes just hours before the president’s final debate with Democratic rival Joe Biden ahead of the Nov.S. The Philippines is forecast to see a 6. 3 presidential election. Remdesivir has been available under an FDA emergency use authorization (EUA) since May, after a study led by the National Institutes of Health showed it reduced hospital stays by five days. Remdesivir has become the standard of care for patients hospitalized with severe COVID-19 after a major study led by the National Institutes of Health showed that it reduced hospital stays by five days. However, the World Health Organization (WHO) last week said its global trial of COVID-19 therapies found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. It has been gradually reopening the economy to allow more businesses to resume operations and more people to go back to work, but partial restrictions in and around the capital Manila remain to keep the virus spread in check. That study has not been reviewed by outside experts. We're rounding the corner.

Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning that patients and their doctors were aware of which treatments were being used. Remdesivir , which will be sold under the brand name Veklury, costs $3,120 for a five-day treatment course, or $2,340 for government purchasers such as the Department of Veterans Affairs. Shares of Gilead rose 4.3% in after hours trading to $63.30. Trump's demeanor changed in the first moments of the debate, with the normally combative tycoon speaking of his son's COVID-19 diagnosis and not immediately going on attack.

Remdesivir has become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival. The drug also has not been proven to significantly help moderately-ill patients, and many doctors remain wary of using it in patients with less severe illness. Gilead Sciences Inc pharmaceutical company is seen after they announced a Phase 3 Trial of the investigational antiviral drug remdesivir in patients with severe coronavirus disease (COVID-19), during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. Some 45 million Americans are estimated to have joined an unprecedented wave of early voting and polls indicate that almost all voters have already firmly made up their minds.

(Reuters/Mike Blake, file) “The formal FDA approval doesn’t change our (sales) estimates or outlook for remdesivir given it has already been branded standard-of-care prior to formal approval,” Raymond James analyst Steven Seedhouse said in a research note, calling the prescribing guidelines and approval “pretty much a best case for Gilead,” given the WHO results questioning remdesivir ‘s benefits. Gilead said it is currently meeting demand for the drug in the United States and anticipates meeting global demand by the end of October. The company said Veklury has regulatory approvals or temporary authorizations in about 50 additional countries. Also on Thursday, the FDA issued a new emergency use authorization for remdesivir to treat hospitalized pediatric patients under age 12 who weigh enough to receive an intravenous drug. Gilead said it is still working to understand the full potential of remdesivir , in different settings and as part of combination therapy approaches. At one point, Biden turned to the president and told him to "shut up.

The company is also developing an inhaled version of the drug that might be used outside a hospital setting, if approved. — Reporting by Vishwadha Chander in Bengaluru and Deena Beasley in Los Angeles; Editing by Cynthia Osterman and Bill Berkrot .