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First ever benefit-risk analysis is "favourable" for remdesivir as COVID-19 treatment

The UK-based Drug Safety Research Unit (DSRU) has reported its findings from the first ever systematic benefit-risk analysis of Gilead’s remdesivir, one of the leading hope in the treatment of COVID-19, noting that it found the drug to have a tentatively “favourable” profile.

The team at DRU evaluated public data in peer reviewed journals and some clinical data which has not yet been published in order to build a profile of the therapy which detailed “all possible benefits and risks for COVID-19 patients receiving remdesivir”.

Japan authorises exceptional approval of Gilead's remdesivir for severe COVID-19

Image credit: BlackRiver, https://commons.wikimedia.org/wiki/File:GovernmentOfficeComplexNo5.jpg

Remdesivir, perhaps the leading hope in the race against COVID-19, has secured approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) under the brand name Veklury for the treatment of severe COVID-19, its license holder Gilead has announced.

The antiviral therapy has emerged as the most effective treatment available thus far against the virus amongst a dearth of alternatives, though the mostly-positive efficacy data accumulated so far has been the subject  of criticism due to small study sizes which have often lacked control arms or have not been peer-reviewed.

FDA approves emergency use of Gilead's remdesivir for hospitalised COVID-19 patients

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.

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The search for a COVID-19 treatment has ramped up this week, with two new studies detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with coronavirus, while researchers in America have been studying famotidine, the active ingredient in Pepcid, as a potential drug to help alleviate symptoms of the virus.

Two studies reveal "positive" data for Gilead's remdesivir in hospitalised COVID-19 patients

Image Credit:Michael Vi/Shutterstock

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 said that it had been made aware of “positive data” emerging from a randomised, controlled trial sponsored by the National Institute of Allergy and Infectious Diseases’ (NIAID) – the first in the US to test a therapy for the novel coronavirus – in hospitalized patients with advanced COVID-19 and lung involvement, noting that the trial had met its primary endpoint.

Leading COVID-19 hope remdesivir fails to provide clinical benefit in first randomised trial

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.

In the China-based trial of 237 participants, 158 were randomised to receive remdesivir, while 79 received placebo plus standard of care. It was found that remdesivir failed to reduce the amount of the virus present in the bloodstream, and patients treated with it did not show clinical improvement.

Gilead's remdesivir significantly reduces COVID-19 symptoms in rhesus monkeys in NIH trial

Image credit: J.M.Garg,, https://commons.wikimedia.org/wiki/File:Rhesus_Macaque_(Macaca_mulatta)_in_Kinnarsani_WS,_AP_W_IMG_5792.jpg

A study from the National Institutes of Health has shed more light on the efficacy of Gilead’s promising antiviral therapy remdesivir in the fight against COVID-19, showing that the drug was able to “significantly reduce” clinical disease and lung damage in rhesus macaque monkeys infected with the novel coronavirus SARS-CoV-2.

The study utilised the same dosing and treatment procedures as those applied to human patients hospitalised with COVID-19 in another large, multicentre study conducted by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

Leaked data show Gilead's remdesivir allows severe COVID-19 patients to be discharged after six days

Image Credit:Michael Vi/Shutterstock

The clinical benefit of Gilead’s promising antiviral therapy Remdesivir has been touted in the treatment of severe cases of COVID-19 after anecdotal reports of its success were obtained from a trial conducted at the University of Chicago Medicine.

Many have high hopes for the therapy, which was originally trialled as an Ebola treatment and has pulled to the front of the pack in the race for an effective treatment in the short term for severe cases of COVID-19.

Gilead halts COVID-19 remdesivir trial due to enrolment issues, efficacy of the drug uncertain

A clinical trial in China investigating Gilead’s antiviral therapy remdesivir as a potential treatment for COVID-19 has been placed on hold after it failed to enrol an adequate number of participants, sending the company’s shares down by 3%.

The Phase 3 trial sought to determine the drug’s efficacy in mild to moderate cases of COVID-19 in hospitalised patients, with time to clinical recovery being the primary measure of success. It was thought that the drug could provide more benefit in this patient population than in more severe cases.

Judge increases the amount of damages Gilead owes Bristol-Myers Squibb in CAR-T legal dispute

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A judge has ruled that Gilead Sciences owe Bristol-Myers Squibb (BMS) additional funds after infringing on one of the company's patents.

In December, a California jury decided to award Bristol-Myers Squibb $752 million regarding Gilead’s CAR-T treatment Yescarta. Gilead had acquired Kite Pharma in 2017 to gain Yescarta, and Bristol-Myers Squibb alleged the treatment's development was based on a patent owned by Juno therapeutics, that BMS acquired in 2018.

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