HIV/AIDS

ViiV Healthcare and UNC Chapel Hill Announce Five Year Renewal of Innovative HIV Cure Partnership

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, and the University of North Carolina at Chapel Hill, a leading global public research university with significant expertise in HIV basic and clinical research, today announced a five-year, $20 million …

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NIAID Announces HIV Vaccine Trial HVTN 702 Stopped Early for Non-Efficacy

NEW YORK, Feb. 3, 2020 /PRNewswire/ — Today the US National Institute of Allergy and Infectious Diseases (NIAID) announced that HVTN 702, a large-scale HIV vaccine efficacy trial of a canary pox-based vaccine candidate, has been stopped vaccinations because the vaccine does not prevent HIV. HVTN 702 (also known as …

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Gilead Sciences Licenses Portfolio of HIV Antibodies From The Rockefeller University

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the company has licensed The Rockefeller University’s portfolio of broadly neutralizing antibodies (bNAbs) against HIV, including the two clinical-stage agents 3BNC117 and 10-1074. These investigational agents have potential for use in HIV long-acting therapies for treatment and prevention, as …

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Xencor and Gilead Enter License Agreement for Use of XmAb Antibody Technologies in Investigational Agents for HIV

MONROVIA, Calif.–(BUSINESS WIRE)–Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune disease, asthma and allergic diseases, today announced it has entered into a technology license agreement in which Gilead Sciences, Inc., will access Xencor’s Xtend™ extended half-life and Cytotoxic XmAb® Fc technologies for …

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ViiV Healthcare Receives Complete Response Letter from the FDA for its Investigational Long-Acting HIV Regimen

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically …

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ViiV Submits Fostemsavir NDA to the FDA for Treatment of HIV in Adults with Few Treatment Options Available

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of …

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Exposure to HIV Drug in the Womb May Increase Risk of Microcephaly, Developmental Delays in Children

BETHESDA, Maryland, Nov. 18, 2019 /PRNewswire-HISPANIC PR WIRE/ — Children born to women on HIV therapy containing the drug efavirenz were 2 to 2.5 times more likely to have microcephaly, or small head size, compared to children born to women on regimens of other antiretroviral drugs, according to an analysis …

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FDA Grants De Novo Designation for Vela Diagnostics’ Next Generation Sequencing HIV-1 Genotyping Assay

FAIRFIELD, N.J.–(BUSINESS WIRE)–Vela Diagnostics announced today that it has received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations (DRMs). The Sentosa® SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, …

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ViiV Submits sNDA to the FDA for Use of Dovato in Virologically Suppressed Adults with HIV-1

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Dovato (dolutegravir and lamivudine) as a switch treatment for …

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FDA Approves Gilead’s Descovy for HIV Pre-Exposure Prophylaxis

FOSTER CITY, Calif.–(BUSINESS WIRE)–Oct. 3, 2019– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP™ is indicated to reduce the risk of sexually acquired HIV-1 infection in …

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