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FDA turns down Gilead’s JAK inhibitor filgotinib in rheumatoid arthritis, endangering 2020 approval hopes

Gilead’s JAK inhibitor filgotinib has been unexpectedly knocked back by the FDA as a therapy to treat moderately to severely active rheumatoid arthritis (RA), jeopardising the company’s ability to secure approval before the end of this year.

In a Complete Response Letter (CRL) sent to Gilead in response to its New Drug Application, the US regulator asked for additional data from two clinical studies due to concerns over the benefit/risk profile of the medication when administered in a 200mg dose.

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.

Gilead applies for FDA approval to treat coronavirus patients with remdesivir

Photo by FDA/CDC

Gilead Sciences has asked the FDA to approve its drug remdesivir to treat COVID-19 patients.

The drug would go under the brand name of Veklury. The treatment is already available on an emergency basis for people suffering with severe symptoms from coronavirus. It has not received general approval to treat the virus in the US, but has in several European countries and Japan.

Kite secures FDA approval for second CAR T therapy Tecartus in relapsed or refractory mantle cell lymphoma

Kite Pharma has chalked up another regulatory success for its parent company Gilead with the news that the FDA has awarded approval to Tecartus (brexucabtagene autoleucel), the company’s second approved chimeric antigen receptor (CAR) T cell therapy after Yescarta, and the first authorised for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), a rare form of non-Hodgkin lymphoma.

The decision comes on the heels of a priority review and Breakthrough Therapy Designation awarded to the therapy, and was based on trial data which showed that Tecartus

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 acquires 49.9% of Pionyer Therapeutics in potential $1.5bn+ deal

Gilead has announced its intention to acquire 49.9% of shares in cancer immunotherapy specialist Pionyr Therapeutics with a payment of $275 million, as part of a deal that could be worth up to an additional $1.47 billion.

Pionyr develops its proprietary Myeloid Tuning therapies, which can potentially provide benefit to cancer patients who do not show clinical improvement with checkpoint inhibitors. This includes two candidates, known as PY314 and PY159, which have shown preclinical promise in solid tumours when combined with anti-PD(L)1 agents.

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.

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