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FDA Accepts NDAs for Merck’s Investigational NNRTI for Treatment of HIV-1 Infection

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults. …

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FDA Approves Ortho Clinical Diagnostics’ HIV Combo Test on Immunodiagnostic System

RARITAN, N.J., Dec. 18, 2017 /PRNewswire/ — Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, announced that its VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the U.S. Food and Drug Administration for use on Ortho’s VITROS 3600 Immunodiagnostic …

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CDC Report Finds Frequency of HIV Testing and Time from Infection to Diagnosis Improve

ATLANTA, Nov. 28, 2017 /PRNewswire-USNewswire/ — A new CDC Vital Signs report published today finds that HIV is being diagnosed sooner after infection than was previously reported. According to the report, the estimated median time from HIV infection to diagnosis was three years in 2015. CDC previously estimated that, in …

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FDA Approves ViiV Healthcare’s Juluca for Treatment of Patients with HIV

London, 21 November 2017 – ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Juluca®, indicated as a complete regimen for the maintenance treatment of HIV-1 infection in adults who …

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Sanofi and NIH Researchers Develop Three-in-One Antibodies to Treat HIV

CAMBRIDGE, Mass., Sept. 20, 2017 /PRNewswire/ — In a landmark study published in the journal Science today, researchers produced genetically engineered antibodies with the highest activity and breadth of coverage yet seen against human immunodeficiency virus (HIV-1). Natural antibodies recognize a single target on a foreign protein. In this study, …

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FDA Expands Approval of Epculsa for the Treatment of Hepatitis C in Patients Co-Infected with HIV

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved updated labeling for Epclusa® (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use …

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Merck’s Investigational Doravirine Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from the DRIVE-AHEAD study, the second of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of doravirine, the company’s investigational, non-nucleoside reverse transcriptase inhibitor (NNRTI), for the treatment …

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Gilead Announces Late-Stage Results for Investigational Triple-Combo Therapy for Treatment of HIV

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed 48-week results from two Phase 3 studies (Studies 1489 and 1490) evaluating the efficacy and safety of a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a …

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Gilead Submits Application for Investigational Triple Therapy HIV Treatment to the FDA

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 …

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Gilead’s Investigational HIV Combo Meets Primary Endpoint in Four Late-Stage Studies

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq:GILD) today announced that four Phase 3 studies evaluating a fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection met their primary objectives of non-inferiority. Three of the …

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