Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for SUSTIVA (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg.
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"The Indonesian government hopes to implement one of the largest ever examples of 'compulsory licensing,' which will enable the generic manufacture of drugs still under patent," IRIN reports.
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Three antiretroviral-based strategies intended to prevent HIV infection among women did not prove effective in a major clinical trial in Africa.
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Gilead Sciences, Inc. announced today its results of operations for the fourth quarter and full year 2012.
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Gilead Sciences, Inc. today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.
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Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults.
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Since the start of 2012, a new drug called rilpivirine has been available for adult patients infected with the human immunodeficiency virus type 1 (HIV-1). It is marketed by two different pharmaceutical companies, by one as a single agent (trade name Edurant-) and by the other as a fixed combination with other HIV drugs (trade name Eviplera-).
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Gilead Sciences, Inc. today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate, an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective.
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Several large clinical trials have demonstrated that a daily oral dose of one or two antiretroviral drugs used to treat HIV infection can prevent infection in an approach known as pre-exposure prophylaxis, or PrEP.
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The U.S. Food and Drug Administration today approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.
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Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.
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Gilead Sciences Inc. announced Thursday that it plans to partner with Mylan Inc., Ranbaxy Laboratories Ltd. and Strides Arcolab Ltd. "to promote access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine in developing countries," the Wall Street Journal reports.
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Mylan Inc. today announced the establishment of a new agreement between its subsidiary Mylan Laboratories Limited and Gilead Sciences Inc. Under this agreement, Mylan has licensed the rights to produce and market generic versions of Gilead HIV/AIDS therapies containing Emtricitabine, including single and fixed-dose combinations.
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Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2012.
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A large clinical trial testing the long-term safety and effectiveness of a new approach for preventing HIV in women - a vaginal ring used once a month - is now underway in Africa, researchers announced today at the XIX International AIDS Conference (AIDS 2012).
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Included in the 2012 International Antiviral Society-USA panel recommendations for human immunodeficiency virus (HIV) patient care is that all adult patients, regardless of CD4 cell count, should be offered antiretroviral therapy (ART), according to an article in the July 25 issue of JAMA, a theme issue on HIV/AIDS.
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Scientists are launching the first clinical trial to test whether drug regimens containing maraviroc, a medication currently approved to treat HIV infection, are also safe and tolerable when taken once daily by HIV-uninfected individuals at increased risk for acquiring HIV infection. The eventual goal is to see if the drug regimens can reduce the risk of infection.
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The daily pill is the first aimed at reducing the risk of contracting HIV in healthy people who are at high risk of contracting AIDS. It will have a boxed warning that it should be used only by people whose HIV-negative status is confirmed prior to prescription and at least every three months after.
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Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truto reduce the risk of sexually-acquired HIV infection in adults at high risk.
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Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
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