News for Gilead Sciences
Dec 31 · 3:59:00 PM · Source: Zacks
Gilead Sciences received a major pipeline setback with disappointing results from a phase III trial of darusentan in which it failed to achieve its primary endpoint.
The drug was being studied under an international clinical trial (DAR-312) for the treatment of resistant hypertension. As a result of the setback, Gilead is considering the option of dropping the program so that its resources can be utilized for other potential candidates rather than conducting another intensive phase III study.
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by Michael Oliveto
Dec 8 · 3:17:00 PM · Source: Reuters
U.S. Food and Drug Administration staff cited concerns on Tuesday with the design and analysis of clinical studies intended to support the effectiveness of Gilead Sciences's experimental cystic fibrosis drug.
"There are concerns that assumptions used in the analysis could have been determined retrospectively," the staff said in their 48-page briefing document.
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by Michael Oliveto
Dec 8 · 3:14:00 PM · Source: The Economic Times
Gilead Sciences has filed an appeal in the Indian Intellectual Property Appellate Board (IPAB) to challenge a recent order by an Indian Patent Office that rejected two patent claims for its best seller drug Viread (tenofovir disoproxil fumarate).
In August, the Indian Patent Office in Delhi rejected two patents sought by the firm for Viread after patient groups and Indian company Cipla challenged its patentability.
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by Michael Oliveto
Nov 5 · 1:02:00 PM · Source: Business Wire
Gilead Sciences today announced the presentation of three-year (144-week) open label data from two pivotal Phase III clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread® (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.
These new data show that the majority of patients who received Viread for up to 144 weeks experienced sustained suppression of HBV DNA levels in the blood to below 400 copies/mL (87 percent in Study 102 and 71 percent in Study 103). Additionally, cumulatively over 144 weeks, 8 percent of all patients in Study 103 (HBeAg-positive) experienced “s” antigen (HBsAg) loss, which can contribute to resolution of chronic hepatitis B infection. Notably, no mutations associated with resistance to Viread developed in any patients up to 144 weeks of treatment.
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by Michael Oliveto
Oct 22 · 3:06:00 PM · Source: Press Release
Gilead Sciences reported Q3 earnings of $0.72 per share on net income of $673 million compared to $0.52 per share on net income of $496 million in the year ago period.
Product sales increased 23 percent to a record $1.65 billion for the third quarter of 2009, compared to $1.34 billion in the third quarter of 2008. This increase in sales was driven primarily by Gilead’s antiviral franchise, including the strong growth in sales of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) and continued growth in sales of Truvada® (emtricitabine/tenofovir disoproxil fumarate), as well as the addition of Ranexa®Â (ranolazine) to our commercial portfolio.
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by Michael Oliveto
Oct 21 · 3:11:00 PM · Source: Reuters
Gilead reported Q3 earnings of $0.72 per share on net income of $673 million versus $0.52 per share on net income of $495.9 million in the year ago period.
The results beat the average analyst forecast of 67 cents a share. Quarterly revenue rose 31% to $1.8 billion.
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by Michael Oliveto
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