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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.

Five-day remdesivir regimen shows promising clinical benefit in COVID-19 patients, Phase 3 data shows

Image credit: David Paul Morris/Bloomberg

Gilead has unveiled eagerly anticipated new Phase 3 data on the addition of its antiviral therapy remdesivir to standard of care (SoC) generated greater clinical benefit than SoC alone in moderately ill COVID-19 patients, specifically those with evidence of pneumonia without reduced oxygen levels.

The new data comes around a month following the release of previous findings from the SIMPLE study which previously compared five-day and 10-day regimens

Gilead's magrolimab shows promising responses in untreated myelodysplastic syndrome and acute myeloid leukaemia at ASCO 2020

Gilead took the opportunity at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting to unveil new Phase 1b data on the combination of its investigational anti-CD47 monoclonal antibody magrolimab with azacitidine, showing positive responses in treatment-naïve myelodysplastic syndrome (MDS) and acute myeloid leukaemia (AML) patients.

Sixty-eight trial participants had received the drug combo by the time of data cut-off; 39 had higher-risk MDS, while 29 were AML patients who were not eligible for intensive chemotherapy. Both groups were previously untreated.

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,

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.

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