HIV/AIDS

FDA Approves ViiV Healthcare’s Rukobia, a First-in-Class Treatment for HIV in Adults with Few Treatment Options

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection …

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FDA Approves First-Ever Dispersible Tablet Formulation of Tivicay PD, a Once-Daily Treatment for Children Living with HIV

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment …

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Global HIV Prevention Study to Stop Early After ViiV’s LAI Formulation of Cabotegravir Dosed Every Two Months Shows Higher Efficacy than Daily Oral PrEP

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the interim analysis of the HIV Prevention Trials Network (HPTN) 083 study evaluating the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention. In the study, …

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FDA Approves Bristol Myers Squibb’s Pomalyst for AIDS-Related and HIV-Negative Kaposi Sarcoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that Pomalyst® (pomalidomide) was approved by the U.S. Food and Drug Administration (FDA) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative.3 Patients with AIDS-related Kaposi sarcoma should …

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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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