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Gilead

Gilead's lenacapavir meets primary goal in heavily treated and multidrug resistant HIV-1

Gilead has pulled back the curtain on promising new data for its long-acting HIV-1 capsid inhibitor lenacapavir for heavily treated and multidrug resistant HIV-1 infection, an area of great unmet need.

The Phase 2/3 data was generated from 36 recruited patients with multi-class HIV drug resistance and detectable viral load who were not seeing their disease controlled with their current regimen.

WHO warns regulators to consider all available evidence before approving remdesivir for COVID-19

The World Health Organization’s Chief Scientist Soumya Swaminathan has warned that experts and regulators assessing the use of Gilead’s remdesivir should consider all the available evidence before awarding marketing authorisation to treat COVID-19, and not just the FDA’s approval last week. 

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

The FDA has approved Gilead’s antiviral therapy Veklury (remdesivir) for the treatment of hospitalised COVID-19 patients, making it the first and only therapy to receive full marketing authorisation to treat the virus in the US.

The approval concerns patients at least 12 years old and weighing at least 40kg, and the drug is only to be administered in a hospital or healthcare setting

Gilead's Biktarvy proves non-inferior to standard care for HIV in Black and African American patients

Gilead has revealed promising new Phase 3 data reinforcing the non-inferiority of Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg) compared to standard care in treating Black and African American patients with HIV-1.

The 495 participants in the study self-identified as Black or African American and had failed to control their disease with treatments in the past or proved resistant to treatment. All participant HIV was virologically suppressed at the time of analysis.

European Commission stands by €1bn remdesivir supply deal despite disappointing COVID-19 benefit

As Europe continues to face down a rising second wave of COVID-19, the European Commission quickly moved to secure a new €1 billion supply deal with Gilead on behalf of 37 nations within the European Union and the European Economic Area to replenish rapidly diminishing stocks of remdesivir as a treatment for infection with the virus.

However, this was before the pharma firm revealed

Gilead to meet rising remdesivir demand in Europe with new supply deal

The European Commission (EC) has signed a new joint procurement agreement (JPA) with pharma firm Gilead to improve access to its antiviral therapy remdesivir for the treatment of COVID-19 as stocks of the drug begin to run dry worldwide.

Under the terms of the agreement, 37 nations across the European Union, including member states and those within the European Economic Area (EEA), will have the option to order doses of the drug.

Japan approves Gilead and Eisai's Jyseleca for rheumatoid arthritis

Gilead and Eisai have secured approval for their oral JAK1 preferential inhibitor Jyseleca (filgotinib) from the Japanese Ministry of Health, Labour and Welfare as a treatment for rheumatoid arthritis (RA), it has emerged.

The approval relates to patients for whom conventional therapies for the prevention of structural joint damage have not been effective.

Gilead agrees to pay $97 million to settle Medicare kickbacks case

Photo by Mike Mozart https://www.flickr.com/photos/jeepersmedia/49449461223

Gilead has agreed to pay $97 million to resolve claims from the US Government that it used an independent charity to pay illegal kickbacks to cover Medicare patients’ upfront costs for its drug Letairis. 

Gilead scoops up Immunomedics in deal worth $21 billion

The Board of Directors from both companies have unanimously agreed for Gilead to acquire Immunomedics for $88 per share in cash, in a new deal which represents a valuation of the latter company at $21 billion.

The primary focus of the deal for Gilead is Immunomedics’ Trop-2 directed antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy), which it scoops up as part of the agreement.

Gilead and Jounce Therapeutics forge immuno-oncology partnership worth a potential $700m+

Gilead and Jounce Therapeutics have come together in a new immuno-oncology partnership potentially worth over $700 million.

The primary drive of the deal for Gilead is to secure exclusive licensing rights to Jounce’s JTX-1811, a monoclonal antibody which targets the chemokine receptor CCR88 to selectively deplete immunosuppressive tumour-infiltration T regulatory (TITR) cells.

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