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HIV/AIDS

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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Path to End HIV Could Be Within Reach for United States in Next Decade

The United States could be on track within the next decade to see significant steps towards ending the HIV epidemic in this country, suggests new research from the Johns Hopkins Bloomberg School of Public Health and Brigham and Women’s Hospital. The researchers say their findings reveal that, with adequate commitment, …

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FDA Grants Tentative Approval to Mylan’s HIV Drug Combo Under PEPFAR

HERTFORDSHIRE, England and PITTSBURGH, March 20, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Efavirenz, Lamivudine and …

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Gilead Presents Positive Mid-Stage Data for its Investigational HIV Candidate Bictegravir

SEATTLE–(BUSINESS WIRE)–Feb. 13, 2017– Gilead Sciences, Inc. (NASDAQ: GILD) today announced data from a Phase 2 study evaluating the efficacy, safety and tolerability of a combination of bictegravir (75 mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) versus dolutegravir (50 mg) (DTG) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) in treatment …

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Researchers Use CRISPR to Accelerate Search for HIV Cure

Researchers at UC San Francisco and the academically affiliated Gladstone Institutes have used a newly developed gene-editing system to find gene mutations that make human immune cells resistant to HIV infection. The team built a high-throughput cell-editing platform using a variant of CRISPR/Cas9 technology that allowed them to test how …

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