Janssen Submits New Drug Application to U.S. Food and Drug Administration for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1
Janssen seeks approval for investigational regimen that aims to combine efficacy, durability, and the high genetic barrier to resistance of darunavir with the renal and bone safety profile of emtricitabine/tenofovir alafenamide in a once daily pill (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 19, 2017 Category: Pharmaceuticals Source Type: news
Janssen Announces Pivotal Phase 3 Study Results for Investigational Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection in Adults Switching from Boosted Protease Inhibitors Plus Emtricitabine and Tenofovir Disoproxil Fumarate Regimens
EMERALD 48-week safety and efficacy results published in The Lancet HIV and to be presented at IDWeek (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 6, 2017 Category: Pharmaceuticals Source Type: news
European Commission Approves Symtuza ® for the Treatment of HIV-1 In Adults and Adolescents in Europe
- Symtuza ® is the only darunavir-based single-tablet regimen (STR) approved for the treatment of HIV-1 in the European Union (Source: Johnson and Johnson)
Source: Johnson and Johnson - September 26, 2017 Category: Pharmaceuticals Source Type: news
Janssen Submits NDA to U.S. FDA for the First Darunavir-Based Single Tablet Regimen for the Treatment of HIV-1
TITUSVILLE, NJ, Sept. 25, 2017 – Janssen Research& Development, LLC today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for darunavir 800mg/cobicistat 150mg/emtricitabine... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 25, 2017 Category: Drugs & Pharmacology Source Type: news
Janssen reports positive results from Phase III darunavir-based HIV regimen trial
Janssen-Cilag International has reported positive results from a Phase III clinical trial (EMERALD) of darunavir containing a single-tablet regimen (STR) in patients with human immunodeficiency virus type 1 (HIV-1). (Source: Drug Development Technology)
Source: Drug Development Technology - July 25, 2017 Category: Pharmaceuticals Source Type: news
Janssen Receives Positive CHMP Opinion for SYMTUZA ™
The First Darunavir-Based Single-Tablet Regimen for the Treatment of HIV
- Proven efficacy and durability of darunavir combined with the improved renal laboratory and bone mineral density profile of emtricitabine/tenofovir alafenamide as compared to emtricitabine/tenofovir disoproxil fumarate into one single tablet (Source: Johnson and Johnson)
Source: Johnson and Johnson - July 21, 2017 Category: Pharmaceuticals Source Type: news
Johnson & Johnson at IAS 2017: Latest Innovations from its Janssen Pharmaceutical Companies Include First In-Human Data for Investigational Preventive HIV-1 Vaccine and Phase 3 Pivotal Trial Results for Darunavir-Based, Single-Tablet Regimen
First in-human, Phase 1/2a data from APPROACH preventive HIV-1 vaccine clinical trial to be featured in oral presentation and included in official IAS press program.
Interim results from the Phase 3 pivotal EMERALD trial investigating darunavir-based single-tablet regimen selected for oral presentation; data submitted to regulatory authorities for EMA approval, September 2017. (Source: Johnson and Johnson)
Source: Johnson and Johnson - July 12, 2017 Category: Pharmaceuticals Source Type: news
Switching From ATV or LPV to DRV Improves Kidney Function Switching From ATV or LPV to DRV Improves Kidney Function
HIV patients who switched their protease inhibitor to darunavir realized an improvement in renal function.AIDS (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - March 6, 2017 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news
Darunavir Linked to Heightened Heart Disease Risk Darunavir Linked to Heightened Heart Disease Risk
The early protease inhibitors are known to increase risk for heart attack, stroke, and sudden cardiac death. Now, data from the D:A:D study raise concerns about next-generation drugs.Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - February 17, 2017 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news
Darunavir Associated with Heart Disease (CME/CE)
(MedPage Today) -- But atazanavir use in HIV patients not linked to cardiovascular disease (Source: MedPage Today Cardiovascular)
Source: MedPage Today Cardiovascular - February 17, 2017 Category: Cardiology Source Type: news
Merck ’s Doravirine, an Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) for the Treatment of HIV-1 Infection, Met Primary Efficacy Endpoint in Pivotal Phase 3 Trial
Dateline City:
KENILWORTH, N.J. Data Presented at CROI Showed Doravirine Was Non-inferior to Ritonavir-boosted Darunavir in Treatment-na ïve Adults after 48 weeks of TreatmentKENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced results of a pivotal Phase 3 clinical trial evaluating
the safety and efficacy of doravirine (MK-1439), an investigational
non-nucleoside reverse transcriptase inhibitor (NNRTI).Language:
EnglishContact: MerckMedia:Doris Li, 908-246-5701Carmen de Gourville, 267-664-0146orInvestors:Teri...
Source: Merck.com - Research and Development News - February 14, 2017 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK Doravirine HIV MSD NYSE:MRK Source Type: news
Efficacy of DRV/r Monotherapy vs DRV/r With Two NRTIs Efficacy of DRV/r Monotherapy vs DRV/r With Two NRTIs
How does darunavir/ritonavir monotherapy compare with DRV/r-based triple ART in terms of efficacy and safety?HIV Medicine (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - January 11, 2017 Category: Infectious Diseases Tags: HIV/AIDS Journal Article Source Type: news
Prezcobix (Darunavir and Cobicistat Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - November 14, 2016 Category: Drugs & Pharmacology Source Type: news
Darunavir/Ritonavir in HIV-1-Infected Pregnant Women Darunavir/Ritonavir in HIV-1-Infected Pregnant Women
How does pregnancy affect the pharmacokinetics of this antiretroviral regimen?HIV Medicine (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - November 9, 2016 Category: Infectious Diseases Tags: HIV/AIDS Journal Article Source Type: news
A Study of DRV/r for HIV Post-Exposure Prophylaxis A Study of DRV/r for HIV Post-Exposure Prophylaxis
Should ritonavir-boosted darunavir be considered as part of a HIV post-exposure prophylaxis regimen?HIV Medicine (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - October 4, 2016 Category: Infectious Diseases Tags: HIV/AIDS Journal Article Source Type: news
