Johnson & Johnson to Expand Partnership with U.S. Department of Health & Human Services to Accelerate the Discovery of Potential COVID-19 Treatments
NEW BRUNSWICK, N.J., February 18, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies will expand its existing partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services, to seek treatment solutions for COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2 (also known as 2019-nCoV). This latest collaboration will enhance Janssen’s ongoing work with global partners to screen a library of existing antiviral...
Source: Johnson and Johnson - February 18, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Announces Collaboration with U.S. Department of Health & Human Services to Accelerate Development of a Potential Novel Coronavirus Vaccine
NEW BRUNSWICK, N.J., February 11, 2020 – Johnson & Johnson today announced that its Janssen Pharmaceutical Companies will further expedite its investigational coronavirus vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services. The collaborative partnership with BARDA builds on Johnson & Johnson’s multipronged response to the new coronavirus disease (COVID-19) outbreak. In addition to Janssen’s ef...
Source: Johnson and Johnson - February 11, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Johnson & Johnson Launches Multi-Pronged Response to Coronavirus Global Public Health Threat
NEW BRUNSWICK, N.J., January 29, 2020 – Johnson & Johnson today announced that it is mobilizing resources at its Janssen Pharmaceutical Companies to launch a multi-pronged response to the novel coronavirus (also known as 2019-nCoV or Wuhan coronavirus) outbreak. As part of this work, the Company has initiated efforts to develop a vaccine candidate against 2019-nCoV and broadly collaborate with others to screen a library of antiviral therapies. Identifying compounds with antiviral activity against 2019-nCoV may contribute to providing immediate relief to the current outbreak.“J&J has a long-standing comm...
Source: Johnson and Johnson - January 29, 2020 Category: Pharmaceuticals Tags: Our Company Source Type: news

D/C/F/TAF Tablet Effective Rapid-Initiation HIV Treatment D/C/F/TAF Tablet Effective Rapid-Initiation HIV Treatment
The single-tablet combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is effective for treating newly diagnosed HIV-1 infection before baseline laboratory results are available, according to results from the DIAMOND phase-3 study.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - January 21, 2020 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

Four-Drug Combination Effective Long-Term for HIV Suppression Four-Drug Combination Effective Long-Term for HIV Suppression
The single-tablet combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) is effective for long-term viral suppression in previously untreated patients with HIV-1 infection, according to 96-week results from the AMBER trial.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - January 3, 2020 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

Symtuza (Darunavir, Cobicistat, Emtricitabine, and Tenofovir   Alafenamide Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 7, 2019 Category: Drugs & Pharmacology Source Type: news

Medical News Today: What are protease inhibitors for HIV?
Protease inhibitors are a class of HIV medication. They block the function of HIV protease enzymes. Taken with other antiretroviral drugs, protease inhibitors help prevent HIV from multiplying. Brand names include Reyataz, Prezista, and Lexiva. Learn about the actions and side effects of protease inhibitors here. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - December 3, 2018 Category: Consumer Health News Tags: HIV and AIDS Source Type: news

Dual Therapy Lets HIV Patients Avoid Problem Drugs
(MedPage Today) -- Dolutegravir plus boosted darunavir an option for people avoiding NRTIs (Source: MedPage Today Infectious Disease)
Source: MedPage Today Infectious Disease - October 10, 2018 Category: Infectious Diseases Source Type: news

Symtuza (Darunavir, Cobicistat, Emtricitabine, and Tenofovir   Alafenamide Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 25, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Approves Symtuza (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
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 (darunavir, cobicistat, emtricitabine and tenofovir alafenamide -... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 18, 2018 Category: Drugs & Pharmacology Source Type: news

Janssen Announces U.S. FDA Approval of SYMTUZA ™ (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
(Source: Johnson and Johnson)
Source: Johnson and Johnson - July 18, 2018 Category: Pharmaceuticals Source Type: news

Janssen Announces U.S. FDA Approval of SYMTUZATM (D/C/F/TAF), the First and Only Complete Darunavir-Based Single-Tablet Regimen for the Treatment of HIV-1 Infection
(Source: Johnson and Johnson)
Source: Johnson and Johnson - July 18, 2018 Category: Pharmaceuticals Source Type: news

Increased Risk of Cardiovascular Disease With Darunavir Increased Risk of Cardiovascular Disease With Darunavir
Cumulative use of ritonavir-boosted darunavir, a contemporary protease inhibitor used to treat HIV, is associated with an increasing risk of cardiovascular disease, according to results from the D:A:D study.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - May 22, 2018 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

Doravirine Effective in Treatment-naive Adults With HIV Doravirine Effective in Treatment-naive Adults With HIV
Doravirine, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), is as effective as ritonavir-boosted darunavir, a protease inhibitor, in treatment-naive adults infected with HIV-1, according to results from the DRIVE-FORWARD trial.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - April 12, 2018 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

Hetero launches FDC combination of key HIV drugs
The FDC drug ‘Darunavir+Ritonavir’ is an anti-retroviral medication indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adult patients. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 14, 2017 Category: Pharmaceuticals Source Type: news

Single-Pill HIV Regimen Scores in New Patients Single-Pill HIV Regimen Scores in New Patients
A new single-tablet regimen with boosted darunavir and tenofovir alafenamide works in virally suppressed HIV patients, AMBER trial results confirm, but when should it be tried in the treatment na ï ve?Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 3, 2017 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news

Investigational Darunavir-Based Single-Tablet Regimen Shows Positive Results in Previously Untreated HIV Patients in Pivotal Phase 3 AMBER Clinical Trial
AMBER 48-week safety and efficacy results to be presented at the 16th European AIDS Conference (Source: Johnson and Johnson)
Source: Johnson and Johnson - October 25, 2017 Category: Pharmaceuticals Source Type: news

Single-tablet Switch Option Effective in Virologically Suppressed HIV Single-tablet Switch Option Effective in Virologically Suppressed HIV
A new single-tablet regimen (STR) that includes the protease inhibitor (PI) darunavir, cobicistat, emtricitabine, and tenofovir alafenamide maintains viral suppression in adults infected with HIV-1, according to results from the EMERALD phase 3 noninferiority trial.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - October 20, 2017 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

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 20, 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 26, 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 Loxam, 908-740-198...
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

FDA Clears Darunavir (Prezista) for Pregnant Women With HIV FDA Clears Darunavir (Prezista) for Pregnant Women With HIV
Data show darunavir, when taken with ritonavir, is safe, well tolerated, and effective during pregnancy and the postpartum period. FDA Approvals (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - July 21, 2016 Category: Drugs & Pharmacology Tags: HIV/AIDS News Alert Source Type: news

FDA Clears Darunavir (Prezista) for Pregnant Women With HIVFDA Clears Darunavir (Prezista) for Pregnant Women With HIV
Data show darunavir, when taken with ritonavir, is safe, well tolerated, and effective during pregnancy and the postpartum period. FDA Approvals (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - July 21, 2016 Category: Drugs & Pharmacology Tags: HIV/AIDS News Alert Source Type: news

U.S. FDA Approves Prezista (darunavir) for Use in Pregnant Women with HIV
TITUSVILLE, N.J., July 18, 2016 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion to the Prezista (darunavir) U.S. Prescribing... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 18, 2016 Category: Drugs & Pharmacology Source Type: news

Prezista (Darunavir) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - June 30, 2016 Category: Drugs & Pharmacology Source Type: news

Darunavir Plus Cobicistat Works Well in Older HIV Groups (CME/CE)
(MedPage Today) -- Agent to boost protease inhibitor drugs seems safe, effective in older patients (Source: MedPage Today Infectious Disease)
Source: MedPage Today Infectious Disease - June 22, 2016 Category: Infectious Diseases Source Type: news

NRTI Sparing Therapy in Virologically Controlled HIVNRTI Sparing Therapy in Virologically Controlled HIV
This study explores the combination of rilpivirine plus boosted darunavir as an option when switching from standard cART in patients who are virologically suppressed. JAIDS: Journal of Acquired Immune Deficiency Syndromes (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - June 1, 2016 Category: Infectious Diseases Tags: HIV/AIDS Journal Article Source Type: news

Comunicado de la FDA sobre la seguridad de los medicamentos: Importantes interacciones entre el medicamento Victrelis (boceprevir) y los medicamentos inhibidores de la proteasa del virus de inmunodeficiencia humana (VIH) reforzados con ritonavir
El 8 de febrero del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) notificó a los profesionales de la salud y a los pacientes que la interacción entre Victrelis (boceprevir), un medicamento inhibidor de la proteasa del virus de hepatitis C (VHC), y ciertos inhibidores de la proteasa del virus de inmunodeficiencia humana (VIH) reforzados con ritonavir (atazanavir, lopinavir, darunavir) tiene el potencial de reducir la eficacia de dichos medicamentos cuando se usan conjuntamente (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - March 4, 2016 Category: Drugs & Pharmacology 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 - March 4, 2016 Category: Drugs & Pharmacology Source Type: news

Janssen Embraces Continuous Manufacturing for Prezista
Strategy seeks CM’s well-researched savings and efficiencies for its Gurabo, Puerto Rico, plant (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 8, 2015 Category: Pharmaceuticals Source Type: news

Darunavir and Trimethoprim-Sulfamethoxazole Cross-ReactivityDarunavir and Trimethoprim-Sulfamethoxazole Cross-Reactivity
This study examines the cross-reactivity between both drugs. AIDS (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 25, 2015 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news

Prezcobix™ (darunavir / cobicistat) for the Treatment of HIV-1
Prezcobix™ (darunavir / cobicistat), discovered and developed by Janssen Therapeutics, is a fixed-dose antiretroviral combination tablet indicated for the treatment of human immunodeficiency virus (HIV-1) infection. (Source: Drug Development Technology)
Source: Drug Development Technology - May 14, 2015 Category: Pharmaceuticals Source Type: news

Africa: Johnson & Johnson Expands Ip Policy to Create Broad Access in 128 Countries for Development of New and Optimized HIV Medicine Formulations for Children Living With HIV
[PR Newswire] Raritan, New Jersey -Expanded Policy will Increase Access for Darunavir Pediatric Formulations in 128 Resource-Limited Countries (Source: AllAfrica News: HIV-Aids and STDs)
Source: AllAfrica News: HIV-Aids and STDs - May 12, 2015 Category: Infectious Diseases Source Type: news

Dolutegravir Remains Superior to Boosted Darunavir for HIV-1Dolutegravir Remains Superior to Boosted Darunavir for HIV-1
Once-daily dolutegravir maintains its higher virological response rates over those of ritonavir-boosted darunavir in treatment-naïve adults with HIV-1 infection, according to 96-week results from the FLAMINGO study. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - April 6, 2015 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news

Darunavir/Cobicistat (Prezcobix) Combo Pill Clears FDADarunavir/Cobicistat (Prezcobix) Combo Pill Clears FDA
The fixed-dose combination of the antiretroviral drug darunavir (800 mg) and the pharmacokinetic enhancer cobicistat (150 mg) is for adults with HIV-1 infection and no darunavir resistance mutations. FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 30, 2015 Category: Consumer Health News Tags: HIV/AIDS News Alert Source Type: news

FDA Approves Two Medications to Treat HIV Infection: Evotaz and Prezcobix
On January 29, 2015, FDA sent e-mails noting the approval of two HIV medications to treat HIV infection:   "On January 29, 2015, FDA approved Evotaz, a fixed dose combination tablet containing 300 mg of atazanavir and 150 mg of cobicistat. Evotaz is indicated in combination with other antiretroviral agents for the treatment of … human immunodeficiency virus (HIV 1) infection in adults."   "On January 29, 2015, FDA approved Prezcobix a fixed dose combination tablet containing 800 mg of darunavir and 150 mg of cobicistat.   "Prezcobix is indicated in combination with other antiretrov...
Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Service of the U.S. Department of Health and Human Services (DHHS) - January 30, 2015 Category: Infectious Diseases Source Type: news

Lupin gets USFDA nod for HIV drug
Drug firm Lupin has received tentative approval from the US health regulator to market a generic version of Prezista tablets, used in treating HIV infection. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 30, 2014 Category: Pharmaceuticals Source Type: news

Reduced Darunavir Dose Maintains HIV SuppressionReduced Darunavir Dose Maintains HIV Suppression
A 600-mg dose of darunavir is as effective as the approved 800-mg dose in maintaining HIV suppression, researchers from Spain report. Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 29, 2014 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news