Specialty Pharma Journal Specialty, Precision & Technology
GLASGOW, Scotland–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today unveiled 96-week results from the pivotal Phase 3 AMBER study of SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (D/C/F/TAF)) at HIV Glasgow in Scotland. D/C/F/TAF is a once-daily darunavir-based single-tablet regimen (STR), …
Tag Archives: HIV-1
October, 2018
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4 October
Merck’s Delstrigo Meets Primary Efficacy Endpoint in Phase 3 Study in Patients with HIV
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation of data from the Phase 3 DRIVE-SHIFT trial evaluating a switch of medication to DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil …
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3 October
Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy for the Treatment of HIV-1 in Adults New to HIV Therapy
FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1489) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, Biktarvy …
July, 2018
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18 July
FDA Approves Janssen’s Symtuza, the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV
TITUSVILLE, N.J., July 17, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SYMTUZA™, the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults. …
January, 2018
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8 January
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. …
September, 2017
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21 September
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, …
July, 2017
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26 July
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 …
June, 2017
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12 June
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 …
February, 2017
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14 February
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 …
April, 2016
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5 April
Gilead’s HIV Therapy Descovy Receives FDA Approval
FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 4, 2016– Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in …