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Remdesivir has a "favourable" benefit/risk profile in COVID-19 but more data needed, DSRU review argues

Southampton’s Drug Safety Research Unit (DSRU) has released a systematic benefit/risk analysis of Gilead’s antiviral drug remdesivir in the treatment of COVID-19, published in Drug Safety.

Remdesivir has attracted much attention as one of the few effective, commercially available treatments for COVID-19 infection, and is one that has been administered to President Donald Trump, who has been infected with the virus.

Lilly's baricitinib/remdesivir combo lowers recovery time in hospitalised COVID-19 patients, according to new data

Eli Lilly has unveiled promising new data from a study investigating the efficacy of baricitinib when combined with with Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

The study, launching on 8 May and sponsored by  the National Institute of Allergy and Infectious Diseases (NIAID), part of the United States National Institutes of Health (NIH), included over 1,000 participants in total receiving 4mg baricitinib in combination in combination with remdesivir.

Racial minority groups are not adequately represented in COVID-19 clinical studies, research argues

New research has warned that minority groups and people of colour are underrepresented in current trials for COVID-19 therapies, despite the disproportionately higher rates of infection, hospitalisation and death faced by these groups.

Experts from the University of Georgia, University of Colorado and Phoebe Putney Memorial Hospital came together to analyse data from some of the leading COVID-19 clinical trials.

Mylan launches generic version of Gilead's remdesivir for COVID-19 patients in India

Mylan has launched its own generic version of Gilead’s remdesivir on the Indian market for the treatment of patients with COVID-19 under the brand name Desrem, it has emerged.

The therapy is priced at Rs 4,800, or $64, for a 100mg vial.

The antiviral therapy has generated a lot of attention in recent months for Gilead after showing promising efficacy across a number of studies in the treatment of patients hospitalised with COVID-19.

New data shows Gilead's remdesivir “potently inhibited” SARS-CoV-2 in human lung cell cultures

New findings published from researchers at Vanderbilt University Medical Center (VUMC) at the University of North Carolina, as well as pharmaceutical firm Gilead, have detailed more positive data for the latter’s antiviral therapy remdesivir in the treatment of COVID-19 disease.

Gilead's remdesivir becomes first EU-recommended therapy for COVID-19

Image credit: Ulrich Perrey

In a crucial step amidst the ongoing pandemic, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Gilead’s antiviral treatment remdesivir be awarded conditional marketing approval of COVID-19, the first for any treatment in Europe for the virus.

To meet prevalent unmet need, the therapy was recommended in patients at least 12 years old with pneumonia who require supplemental oxygen.

Gilead to investigate inhaled formulation of promising COVID-19 therapy remdesivir

Gilead is intent on pushing the applications of its antiviral drug remdesivir after it has shown efficacy in the treatment of COVID-19, with the company now revealing that it intends to begin testing on a new inhaled formulation of the therapy.

Remdesivir is currently administered via intravenous infusion (IV) meaning patients must visit a hospital to receive treatment with the drug.

EMA could approve Gilead’s streamlined remdesivir application for COVID-19 “within weeks”

Image credit: Ulrich Perrey

The European Medicines Agency has received the application from Gilead for the first conditional marketing authorisation (CMA) of its antiviral drug remdesivir in the treatment of COVID-19, it has been revealed, with the agency looking to streamline its review process to approve the therapy for use as soon as possible.

Remdesivir has so far gained perhaps the most traction in the treatment of COVID-19 compared to other therapies, having been shown to reduce recovery times for affected patients in a number of studies.

Australian Taskforce recommends Gilead's remdesivir for routine use in the country's COVID-19 patients

Image credit: Ulrich Perrey

Australia could be set to follow the decisions of other nations around the world in officially licensing Gilead’s antiviral therapy remdesivir in the treatment of COVID-19, after the country’s National COVID-19 Clinical Evidence Taskforce, a specialist team bringing together some of Australia’s leading health groups, has given its recommendation for routine use of the drug.

The taskforce found that available evidence supported the use of remdesivir in moderate, severe or critical cases of COVID-19 in order to speed recovery times in patients.

India and South Korea approve Gilead's remdesivir for emergency use against COVID-19

Image credit: Ulrich Perrey

India and South Korea have moved to follow in the footsteps of the US in approving Gilead’s antiviral therapy remdesivir for emergency use in a bid to fight the ongoing COVID-19 pandemic.

India’s Central Drugs Standard Control Organisation (CDSCO) has approved five different doses of the therapy for the treatment of hospitalised adult patients and children with “severe” manifestations of the disease.

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