Us, Gilead, Coronavirus, Covıd-19

Us, Gilead

Gilead seeks US approval for COVID-19 treatment remdesivir

Gilead seeks US approval for COVID-19 treatment remdesivir

11/8/2020 12:11:00 AM

Gilead seeks US approval for COVID-19 treatment remdesivir

Gilead Sciences Inc said on Monday it has filed a marketing application with the U.S. Food and Drug Administration for its experimental COVID-19 ...

WorldFILE PHOTO: Gilead Sciences Inc pharmaceutical company is seen during the outbreak of the coronavirus disease (COVID-19), in California11 Aug 2020 04:52AMShare this contentBookmarkREUTERS: Gilead Sciences has filed an application with the US Food and Drug Administration seeking full approval for remdesivir, its experimental COVID-19 drug currently used under emergency authorization, the drugmaker said on Monday (Aug 10).

Disney to cut 28,000 jobs at US theme parks in one of biggest layoffs of coronavirus era JPMorgan fined $1.26 billion for manipulating precious metals, treasury market WATCH LIVE at 9am: Donald Trump, Joe Biden go head-to-head in first presidential election debate

The antiviral drug, which helped shorten the hospital recovery time in a US trial, has been at the forefront of the battle against the pandemic after the FDA granted it emergency use authorization (EUA) in May.AdvertisementAdvertisementThe authorization cleared the way for broader use of the drug in more hospitals around the United States, which has recorded over 162,600 COVID-19 deaths and over 5 million infections. But the EUA status is designed to be temporary.

Gilead said its marketing application for remdesivir, to be sold under brand name Veklury, is supported by data from two late-stage trials conducted by the drugmaker and another by the National Institute of Allergy and Infectious Diseases.Remdesivir has already been approved by multiple regulatory authorities around the world, including in the European Union, Australia and Japan.

The US government has secured nearly all of remdesivir's supply through September. To boost the drug's availability globally, Gilead has signed multiple manufacturing and supply deals, including with Pfizer Inc and Britain's Hikma Pharmaceuticals.

AdvertisementAdvertisementA bipartisan group of state attorneys general urged the US government last week to allow other companies to make remdesivir to increase its availability and lower prices.Shares of Gilead were down 1.5 per cent in late afternoon trading.

Oppenheimer analyst Hartaj Singh said investors are worried that if Gilead cannot secure full approval until at least by the end of the year, it might not be able to meet 2020 sales estimates for the drug."On many occasions, government entities are expressly forbidden from buying or utilizing drugs not approved by the FDA and other regulatory authorities."

Read more: CNA »

Sexual offences, quotas and serving NS: K Shanmugam speaks frankly about women’s issues

After launching a series of public engagements on women’s issues in a move towards greater gender equality on Sunday (Sep 20), Home Affairs and Law Minister K Shanmugam sits down with Lin Suling to talk about gender relations, the law and sexual offences, and women in the workplace. He also gives his take on whether quotas would work and responds to comments about women serving National Service.

US sets record as COVID-19 cases top 5 millionThe United States set a record for coronavirus cases on Saturday, with more than 5 million people now infected, according to a Reuters tally, as ...

Top US mall operator Simon faces COVID-19 pandemic painINDIANAPOLIS: Surging COVID-19 infections in big states like California, Texas and Florida are scaring shoppers away from newly reopened malls, ...

Covid-19 cases in US children soared in late July: ReportWASHINGTON (REUTERS) - The number of new Covid-19 cases among children in the United States rose 40% in the last two weeks of July, according to a report released just weeks before tens of millions of American students are scheduled to begin the new school year.. Read more at

US COVID-19 deaths drop for first time in four weeksThe U.S. death toll from COVID-19 fell 16per cent to about 7,200 people last week, the first decline in deaths after four weeks of increases, ...

EU seeks reinstated curbs due to COVID-19 'resurgence'STOCKHOLM: The EU's health agency Monday (Aug 10) urged countries seeing an increase in cases of COVID-19 to reinstate some curbs, warning of a ...

Commentary: 100 days without COVID-19 community transmission – and how New Zealand did itNew Zealand committed relatively early to a clearly articulated elimination strategy and pursued it aggressively, say observers.