For the next few months Talk Evidence is going to focus on the new corona virus pandemic. There is an enormous amount of uncertainty about the disease, what the symptoms are, fatality rate, treatment options, things we shouldn't be doing. We're going to try to get away from the headlines and talk about what we need to know - to hopefully give...

The U.S. Food and Drug Administration on Friday granted emergency use authorization to the antiviral remdesivir to treat COVID-19.

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Penn State Health Milton S. Hershey Medical Center has begun enrolling participants in an international clinical trial evaluating an investigational antiviral drug, remdesivir, for treatment of coronavirus disease 2019 (COVID-19).

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When the coronavirus pandemic began, the pharmaceutical company Gilead pulled remdesivir out of its storeroom. The drug, which had proved to be ineffective against other illnesses, could have a future in the battle against COVID-19. But it's likely not a "game changer."

Japan has fast-tracked the approval of the anti-viral drug remdesivir to be used to treat COVID-19 patients in that country.Speaking to reporters Friday in Tokyo, Japanese Chief Cabinet Secretary Yoshihide Suga confirmed the rare fast-track, four-day approval of remdesivir by the Ministry of Health,...

TOKYO: Japan on Thursday approved Gilead Sciences Inc’s remdesivir as a treatment for Covid-19, making it the country’s first officially authorised drug to tackle the coronavirus disease.

Japan reached the decision just three days after the US drugmaker filed for fast-track approval for the treatment.

“There has so far been no coronavirus medicine available here so it is a significant step for us to approve this drug,” a Japanese health ministry official said at a press briefing. Remdesivir will be given to patients with severe Covid-19 symptoms, he added.

With no other approved treatments for Covid-19, interest in the drug is growing around the world. Administered by intravenous infusion, it was granted authorisation last week by the US Food and Drug Administration for emergency use for the disease caused by the novel coronavirus.

Gilead says the drug has improved outcomes for people suffering from the respiratory disease and has provided data suggesting it works better when given in the early stages of infection.

Japan, with just over 16,000 infections and under 800 deaths, has recorded fewer cases than other major industrialised nations.

However, a steady rise in cases has put pressure on medical facilities in some parts of the country, and a drug that helps patients recover more quickly could help in freeing up hospital beds.

A trial performed by the US Institutes of Health (NIH) showed the drug cut hospital stays by 31 per cent compared with a placebo treatment, although it did not significantly improve survival.

On Monday, Japanese Prime Minister Shinzo Abe extended a month-long state of emergency until the end of May in an attempt to slow the spread of the coronavirus.

Japan as yet does not know when it will get its first doses of remdesivir or how much, the health ministry official said.

Gilead on Tuesday said it was in discussion with several companies, including generic drugmakers in India and Pakistan to produce remdesivir in large quantities.

Remdesivir, which previously failed as a treatment for Ebola, is designed to disable the ability by which some viruses make copies of themselves inside infected cells.

Published in Dawn, May 8th, 2020

Title: Will Remdesivir Help COVID-19 Patients? Two Reports Provide Different Answers
Category: Health News
Created: 4/29/2020 12:00:00 AM
Last Editorial Review: 4/30/2020 12:00:00 AM

Title: Remdesivir (RDV): Experimental Antiviral for Coronavirus (COVID-19)
Category: Medications
Created: 3/26/2020 12:00:00 AM
Last Editorial Review: 5/5/2020 12:00:00 AM

A man in his 30s has been rushed to hospital after a shooting in Camden.

Leading medical experts have described trials for a drug which could treat coronavirus as "a really promising first step" towards overcoming the disease.

Directives from the Centre have to be executed at the state level. So, there are many things that are not in Modi’s hands, says Raamdeo Agrawal.

Remdesivir is currently the world’s best hope for treating COVID-19. But it’s not a silver bullet.

In a clinical trial, the drug remdesivir shortened recovery time for patients with advanced cases of COVID-19, the disease caused by the coronavirus.

Remdesivir, the investigational Gilead Sciences antiviral drug, looks more likely than ever to become the first treatment authorized by the FDA to treat patients with COVID-19. National Institute of Allergy and Infectious Diseases (NIAID) head Anthony Fauci praised the drug after preliminary data released this week from a federally funded trial involving more than 1,000 […]

Regulators on Friday afternoon granted emergency authorization for the Gilead Sciences drug remdesivir as a treatment for patients hospitalized with severe COVID-19 infections. The decision makes the antiviral drug, which is delivered via intravenous infusion, the second drug to receive authorization under the FDA’s emergency guidelines for use against the novel coronavirus. The first was […]

Preliminary results of US government trial show patients who received drug recovered faster than others

Hopes of an effective drug treatment for coronavirus patients have risen following positive early results from a trial of remdesivir, a drug first tried in Ebola patients.

Data from the trial on more than 1,000 severely ill patients in 75 hospitals around the world show that patients put on the drug recovered 31% faster than similar patients who were given a placebo drug instead. Remdesivir cut recovery time from a median of 15 days to 11.

Related: World's stock markets soar on coronavirus treatment hopes

Exclusive: St Vincent’s in Sydney is the only confirmed location so far, as NSW Health negotiates with US pharmaceutical giant Gilead

• Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?
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The US pharmaceutical company Gilead is finalising the location of five hospitals in Australia to receive the highly sought-after experimental coronavirus drug remdesivir.

The only confirmed location is St Vincent’s hospital in Sydney, a major tertiary hospital and the centre of many of the New South Wales outbreak areas. A NSW Health spokeswoman confirmed the health department “has been engaging with Gilead on gaining access to the drug for Covid-19 patients”.

Related: Remdesivir: the antiviral drug is being touted as a possible coronavirus treatment – but will it work?

Gilead’s remdesivir, which has been hailed as one of the few truly promising treatments for COVID-19 at this early stage of the ongoing pandemic, has failed in its first randomised clinical trial, leaked data has revealed.

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

Gilead’s antiviral therapy remdesivir has shown tentatively promising efficacy in the race to find an effective treatment for COVID-19, one of the only therapies to do so at this early stage of the pandemic. Now, the FDA has invoked its Emergency Use Authorization powers to approve the drug for the treatment of patients hospitalised with the novel coronavirus.

South Korea says that remdesivir, traditionally used in treating Ebola, may not be effective enough in treating COVID-19 patients.

New crop of data suggests drug can speed recovery from COVID-19

Move comes after drug showed preliminary efficacy in clinical trial in late April

California’s Gilead Sciences has outlined a plan to ramp up production of newly USA-approved COVID-19…

As had been widely expected, Gilead Sciences on Thursday announced that the Japanese Ministry of Health,…

Gilead Sciences scored a massive win earlier this week with its first positive data readout for investigational candidate remdesivir in treating patients with severe COVID-19. Gilead already has its own supply of the drug humming in anticipation of high demand, but opportunities are out there for a partner to join in. 

Days after U.S. officials reported the first positive controlled data for Gilead's remdesivir in COVID-19, the FDA has given the drug an emergency use authorization.

While Gilead has yet to present a marketing plan for remdesivir—much less a price—ICER figures the COVID-19 drug could be cost-effective at up to $4,460 per patient. That means it could easily rake in blockbuster sales this year, at least theoretically.

Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts wrote.

The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism.

Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more.

When Gilead Sciences scored a groundbreaking FDA emergency use authorization for COVID-19 therapy remdesivir, the company made the unusual move of handing distribution rights to the U.S. government. But the federal rollout has gotten off to a rocky start. 

The FDA has issued emergency use authorization for Gilead Science Inc's (GILD) antiviral drug Remdesivir for the treatment of COVID-19 in adults and children hospitalized with severe disease.

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for.

Since the drug was granted emergency use authorization, doctors have been left with no clear path to get it.

Baba Ramdev will be our guest at The Idea Exchange, an interactive session organised by The Indian Express. Send us your questions for him.

Ronny Gal of Sanford C. Bernstein says he thinks remdesivir will not be the most significant revenue contributor for Gilead Sciences over time. He also explains his rationale for raising the company's price target to $75 from $72.

"This drug makes a big difference, especially if you were worried about a second wave of infections after we reopened the economy," the "Mad Money" host said.

Dr. Scott Gottlieb, Former FDA Commissioner, joins "Closing Bell" to discuss the coronavirus pandemic.

The US food and drug regulatory body has allowed the emergency use of an investigational anti-viral vaccine to treat COVID-19 patients after some researches, including one led by an Indian-American physician, found that the drug helped recover some of the infected cases faster.

The Food and Drug Administration (FDA) gave emergency use authorisation (EUA) for the use of investigational anti-viral Remdesivir for the treatment of COVID-19 patients. "I'm pleased to announce that Gilead now has an EUA from the FDA for Remdesivir," US President Donald Trump told reporters at the White House on Friday.

Remdesivir is given to patients through a vein one time each day for up to 10 days depending on recommendations of healthcare providers. The US National Institute of Allergy and Infectious Diseases (NIAID) announced the results of a trial involving more than 1,000 people on Wednesday.

It found that hospitalised COVID-19 patients with respiratory distress got better quicker than those on a placebo. Specifically, patients on the drug had a 31 percent faster time to recovery. "Although the results were clearly positive from a statistically significant standpoint, they were modest," Anthony Fauci, the scientist who leads the NIAID, said. While not considered a miracle cure, Remdesivir's trial achieved a "proof of concept," according to Fauci that could pave the way for better treatments.

Possible side effects of Remdesivir include infusion-related reactions and increases in levels of liver enzymes. "These are not all the possible side effects of Remdesivir. It is still being studied so it is possible that all of the risks are not known at this time," said the FDA.

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Remdesivir is highly effective in stopping the replication of coronavirus, according to new research published in the iJournal of Biological Chemistry/i by scientists at the University of Alberta.

The US Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) for the experimental remdesivir (anti-viral medication) to treat COVID-19 patients.