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EMA to review Gilead’s Zydelig over safety concerns
14 March 2016 | By Victoria White
The European Medicines Agency's review follows concerns over serious adverse events in ongoing clinical trials of Zydelig (idelalisib)...
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Gilead Sciences
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CHMP adopts positive opinion of Gilead’s Descovy
26 February 2016 | By Victoria White
Descovy is an investigational fixed-dose combination for the treatment of HIV-1 infection in adults and adolescents in combination with other HIV antiretroviral agents...
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Gilead’s MAA for TAF in hepatitis B now under assessment by the EMA
26 February 2016 | By Victoria White
TAF is a novel, targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to Gilead’s Viread at one-tenth of the dose...
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Gilead announces results from study evaluating switching to F/TAF-based regimens from Truvada
24 February 2016 | By Victoria White
At Week 48 of the study, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens in HIV-1 infected adult patients...
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EMA validates Gilead’s Type II variation application for Truvada for PrEP
1 February 2016 | By Victoria White
The application is based on the results of two large placebo-controlled trials of Truvada for PrEP, the Pre-Exposure Prophylaxis Initiative (iPrEX) and Partners PrEP...
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Gilead’s TAF meets primary objectives in two Phase 3 HBV trials
6 January 2016 | By Victoria White
The studies demonstrated that TAF was non-inferior to Gilead’s Viread (tenofovir disoproxil fumarate, TDF) based on the percentage of patients with HBV DNA levels below 29 IU/mL at 48 weeks of therapy...
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EC grants marketing authorisation to Genvoya for HIV-1 infection
23 November 2015 | By
Genvoya is the first TAF-based regimen to receive marketing authorisation in the EU...
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FDA approves new indications for Gilead’s Harvoni
13 November 2015 | By Victoria White
The FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic HCV infection and in patients co-infected with HIV...
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FDA approves Gilead’s Genvoya for the treatment of HIV
6 November 2015 | By Victoria White
Genvoya contains a new form of tenofovir that has not been previously approved...
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Gilead announces Phase 3 results for investigational HIV treatment Genvoya
22 October 2015 | By Victoria White
Genvoya was found to be statistically non-inferior to Stribild based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL...
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Gilead’s GS-5734 given to UK Ebola patient
22 October 2015 | By Victoria White
GS-5734 was discovered as part of Gilead’s programme to screen compounds in its libraries for activity against a range of potential emerging viruses, including Ebola...
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FDA approves Letairis plus tadalafil for pulmonary arterial hypertension
5 October 2015 | By Victoria White
The combination is approved to reduce the risks of disease progression and hospitalisation for worsening PAH, and to improve exercise ability...
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CHMP adopts positive opinion of Genvoya for HIV-1
25 September 2015 | By Victoria White
The CHMP’s recommendation will now be reviewed by the European Commission. If approved, Genvoya would be Gilead’s first single tablet regimen to contain TAF...
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NICE recommends idelalisib for chronic lymphocytic leukaemia
24 September 2015 | By Victoria White
Idelalisib has been recommended in combination with rituximab for adults with chronic lymphocytic leukaemia (CLL) who have relapsed early...
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EMA validates R/F/TAF MAA for the treatment of HIV-1
21 August 2015 | By Victoria White
An MAA for an investigational regimen that combines emtricitabine, tenofovir alafenamide and rilpivirine (R/F/TAF) has been fully validated by the EMA...
