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Raltegravir Lowers HIV in Late Pregnancy (CME/CE)
(MedPage Today) -- Integrase inhibitor lowers viral load to undetectable levels (Source: MedPage Today Pediatrics)
Source: MedPage Today Pediatrics - July 28, 2017 Category: Pediatrics Source Type: news

Dutrebis (Lamivudine and Raltegravir Film-coated Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 3, 2017 Category: Drugs & Pharmacology Source Type: news

Isentress (Raltegravir Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - June 12, 2017 Category: Drugs & Pharmacology Source Type: news

FDA Clears Once-Daily Raltegravir (Isentress HD) for HIV FDA Clears Once-Daily Raltegravir (Isentress HD) for HIV
Isentress HD is given once daily in two 600-mg film-coated tablets in combination with other antiretroviral agents in appropriate patients with HIV-1 infection.FDA Approvals (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - May 31, 2017 Category: Consumer Health News Tags: HIV/AIDS News Alert Source Type: news

FDA Clears Raltegravir (Isentress HD) for HIV
FDA Clears Once-Daily Raltegravir (Isentress HD) for HIV (Source: eMedicineHealth.com)
Source: eMedicineHealth.com - May 31, 2017 Category: General Medicine Source Type: news

Merck Receives FDA Approval of Isentress HD (raltegravir), a New Once-Daily Option for the Combination Treatment of HIV-1 Infection in Appropriate Patients
KENILWORTH, N.J.-- May 30, 2017 (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 approved Isentress HD, a new 1200 mg once-daily dose of the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 30, 2017 Category: Drugs & Pharmacology Source Type: news

Comparable Long-term Outcomes With HIV Regimens Containing Raltegravir, Efavirenz Comparable Long-term Outcomes With HIV Regimens Containing Raltegravir, Efavirenz
Rates of death or progression to AIDS at four years are low and similar with antiretroviral regimens containing raltegravir or efavirenz, according to a new observational study.Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - May 26, 2017 Category: Infectious Diseases Tags: HIV/AIDS News Source Type: news

Merck ’s Isentress receives CHMP positive opinion to treat HIV-1 infection
Merck ’s Isentress (raltegravir) 600mg film-coated tablets have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for the treatment of HIV-1 infection in adults and paedi… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - May 21, 2017 Category: Pharmaceuticals Source Type: news

Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS(R) (raltegravir) 600 mg in the European Union
KENILWORTH, N.J.--(Healthcare Sales & Marketing Network)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted... Biopharmaceuticals, Regulatory Merck, ISENTRESS, raltegravir, HIV/AIDS (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - May 19, 2017 Category: Pharmaceuticals Source Type: news

Merck Receives CHMP Positive Opinion Recommending Approval of ISENTRESS ® (raltegravir) 600 mg in the European Union
Dateline City: KENILWORTH, N.J.KENILWORTH, N.J.--(BUSINESS WIRE)--Merck  (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ISENTRESS® (raltegravir) 600 mg film-coated tablets, in combination with other anti-retroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg.Language: EnglishContact: MerckMedia:P...
Source: Merck.com - Product News - May 19, 2017 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news

July's top stories: GBT's Phase II1 trial GBT440, Merck's Phase III trial ONCEMRK of Isentress
Global Blood Therapeutics (GBT) began the Phase IIa trial (GBT440-007) of GBT440 in adolescents with sickle cell disease (SCD), and Merck reported positive results from its ongoing Phase III pivotal trial ONCEMRK of Isentress (raltegravir) to treat a … (Source: Drug Development Technology)
Source: Drug Development Technology - August 8, 2016 Category: Pharmaceuticals Source Type: news

Merck reports positive Phase III ONCEMRK trial of Isentress to treat HIV-1 infection
US-based pharmaceutical company Merck has reported positive results from its ongoing Phase III pivotal trial ONCEMRK of Isentress (raltegravir) to treat adults with HIV-1 infection. (Source: Drug Development Technology)
Source: Drug Development Technology - July 24, 2016 Category: Pharmaceuticals Source Type: news

Once-Daily Raltegravir Matches Twice Daily Efficacy (CME/CE)
(MedPage Today) -- Trial shows new dosing strategy feasible (Source: MedPage Today Infectious Disease)
Source: MedPage Today Infectious Disease - July 23, 2016 Category: Infectious Diseases Source Type: news

Data for Merck's Investigational Once-Daily Formulation of ISENTRESS ® (raltegravir) Show That at Week 48, a Regimen Containing the Once-Daily Dosing Formulation...
Dateline City: KENILWORTH, N.J. Resulted in Non-Inferior Efficacy and Safety to a Regimen Containing the Approved Twice-Daily Formulation EMA Accepts File Application, Plans Underway to Submit for Licensure to FDA This Year KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced efficacy and safety data in previously untreated adults with HIV-1 infection for the company ’s investigational once-daily formulation of ISENTRESS ® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg), from...
Source: Merck.com - Research and Development News - July 22, 2016 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK HIV ISENTRESS MSD NYSE:MRK Source Type: news

raltegravir (Isentress)
Title: raltegravir (Isentress)Category: MedicationsCreated: 2/5/2010 12:00:00 AMLast Editorial Review: 6/24/2016 12:00:00 AM (Source: MedicineNet HIV General)
Source: MedicineNet HIV General - June 24, 2016 Category: Infectious Diseases Source Type: news

Raltegravir Noninferior as Second-Line ART in Low-Resource SettingsRaltegravir Noninferior as Second-Line ART in Low-Resource Settings
A raltegravir-based regimen is an "appropriate alternative" for second-line antiretroviral therapy in resource-limited settings, a new phase 3 study confirms. Reuters Health Information (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - May 12, 2016 Category: Infectious Diseases Tags: Family Medicine/Primary Care News Source Type: news

Single shot of PrEP drugs is 'as effective as taking HIV pills twice a day'
Scientists at the University of North Carolina found a high-dose of the drug raltegravir injected once a month could offer the same protection against HIV infection as taking PrEP drugs orally twice a day. (Source: the Mail online | Health)
Source: the Mail online | Health - March 22, 2016 Category: Consumer Health News Source Type: news

Long-acting injectable protects against vaginal HIV transmission
(University of North Carolina Health Care) In an effort to minimize obstacles to adherence and prevent vaginal HIV transmission, researchers from the division of infectious diseases at the University of North Carolina School of Medicine and collaborators from Merck demonstrated the effectiveness of a new long-acting formulation of the HIV drug raltegravir in animal models. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - March 21, 2016 Category: Global & Universal Source Type: news

Merck ’s Investigational Once-Daily Formulation of ISENTRESS® (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study
Dateline City: KENILWORTH, N.J. Results to be Presented at Future Medical Meeting, and Regulatory Submissions Planned for 2016 KENILWORTH, N.J.--( BUSINESS WIRE )--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced top-line results from the company ’s Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS ® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults. Language: English Contact: ...
Source: Merck.com - Research and Development News - February 22, 2016 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK ISENTRESS NYSE:MRK Source Type: news

Merck’s Investigational Once-Daily Formulation of ISENTRESS® (raltegravir) Meets Primary and Secondary Endpoints in Pivotal Phase 3 Study
Dateline City: KENILWORTH, N.J. Results to be Presented at Future Medical Meeting, and Regulatory Submissions Planned for 2016 KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced top-line results from the company’s Phase 3 pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of ISENTRESS® (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults. ...
Source: Merck.com - Research and Development News - February 22, 2016 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News #Merck #MRK $MRK ISENTRESS NYSE:MRK Source Type: news

Results of Raltegravir plus combination antiretroviral therapy in early HIV infection
(Mary Ann Liebert, Inc./Genetic Engineering News) Addition of the integrase strand transfer inhibitor raltegravir (RAL) to standard antiretroviral therapy (ART) in ART-naive patients with early HIV infection was not associated with a difference in the quantity of HIV DNA, residual virus in the blood, or CD4+ T-cells containing replication-competent virus, according to a new study published in BioResearch Open Access. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - February 22, 2016 Category: Global & Universal Source Type: news

Raltegravir Prevents HIV Transmission in Newborns (CME/CE)
(MedPage Today) -- Small study suggests integrase inhibitor can help prevent mother-to-child infections. (Source: MedPage Today Infectious Disease)
Source: MedPage Today Infectious Disease - July 24, 2015 Category: Infectious Diseases Source Type: news

Benefits of Early Antiretroviral Therapy With RaltegravirBenefits of Early Antiretroviral Therapy With Raltegravir
When it comes to lowering T-cell activation levels, early vs. late ART initiation doesn't seem to make a difference. AIDS (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 22, 2015 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news

Fat, Lean Mass Grows With Raltegravir and Protease Inhibitors (CME/CE)
(MedPage Today) -- Unclear if gains are an adverse effect or signal of improved health. (Source: MedPage Today Infectious Disease)
Source: MedPage Today Infectious Disease - March 1, 2015 Category: Infectious Diseases Source Type: news

Recent HIV/AIDS News from CDC, FDA, and NIAID
News from CDC February 24, 2015: CDC statement on IPERGAY trial of pre-exposure prophylaxis (PrEP) for HIV prevention among men who have sex with men February 23, 2015: 9 in 10 new U.S. HIV infections come from people not receiving HIV care News from FDA February 18, 2015: Isentress (raltegravir) label update re: aluminum and/or magnesium hydroxide-containing antacids News from NIAID February 26, 2015: HIV controls its activity independent of host cells   February 18, 2015: NIH-funded scientists create potential long-acting HIV therapeutic February 18, 2015: NIH-sponsored HIV vaccine trial ...
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) - February 27, 2015 Category: Infectious Diseases Source Type: news

Merck and MPP partner to supply paediatric HIV drug in developing nations
US-based pharmaceutical firm Merck has entered an agreement with the Medicines Patent Pool (MPP) to provide its paediatric formulations of raltegravir to treat HIV-1 infection in infants and children from four weeks to below 12 years of age in develo… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - February 25, 2015 Category: Pharmaceuticals Source Type: news

Merck Announces Collaboration with the Medicines Patent Pool to Expand Access to Pediatric Formulations of Raltegravir in Developing Countries
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced an agreement with the Medicines Patent Pool (MPP) to license its pediatric formulations of raltegravir for use in treating HIV-1 infection in infants and children from four weeks to under 12 years of age in developing countries. This is the MPP’s first agreement to provide access to an HIV integrase inhibitor for use in combination HIV therapy for infants and children in this age range. Language: ...
Source: Merck.com - Product News - February 24, 2015 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news

Dutrebis (Lamivudine and Raltegravir Film-coated Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 19, 2015 Category: Drugs & Pharmacology Source Type: news

Dutrebis (Lamivudine and Raltegravir Film-coated Tablets) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - February 19, 2015 Category: Drugs & Pharmacology Source Type: news

FDA Approves Dutrebis, Though It Is Not Commercially Marketed in U.S. at This Time
"On February 6, 2015, the FDA approved Dutrebis a fixed dose combination tablet containing 150 mg of lamivudine and 300 mg of raltegravir. Dutrebis tablet is approved for use in combination with other antiretroviral products for the treatment of HIV-1 infection in adults and pediatric patients greater than or equal to 6 years of age weighing at least 30 kg. …    "According to the manufacturer, Merck Pharmaceuticals, Dutrebis, will not be made commercially available in the U.S. at this time."   For more information, view the FDA news release. (Source: AIDSinfo At-a-Glance: Offering Infor...
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) - February 13, 2015 Category: Infectious Diseases Source Type: news

Combination Antiviral Recommended in EU for HIV Treatment Combination Antiviral Recommended in EU for HIV Treatment
A lamivudine/raltegravir combination is expected to ease the daily pill burden for patients with HIV, with efficacy comparable to that of the individual agents. International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 23, 2015 Category: Consumer Health News Tags: HIV/AIDS News Alert Source Type: news

HIV: Non-Efavirenz Regimens Effective in Initial TreatmentHIV: Non-Efavirenz Regimens Effective in Initial Treatment
Phase 3 results from an AIDS Clinical Trials Group RCT suggest that regimens lacking efavirenz have similar efficacy in initial HIV treatment, and raltegravir has better tolerability. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 10, 2014 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news

Raltegravir in Virologically Suppressed Overweight WomenRaltegravir in Virologically Suppressed Overweight Women
When women with central adiposity switch to RAL from a PI or NNRTI, they could experience a significant decrease in sCD14. HIV Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 25, 2014 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news

Could HIV drugs help treat multiple sclerosis?
Conclusion This large cohort study indicates people with HIV appear to be at a lower risk of developing MS. It is not known what causes this association, but possible reasons put forward by the researchers include: immunodeficiency caused by HIV may stop the body attacking itself in the autoimmune condition MS antiretroviral therapy may suppress other viruses in the body, such as those that have been suggested as causing MS Strengths of the study include the large sample size and the very large number of controls, which would limit any bias by confounding factors. However, the study did have a few limitations: A...
Source: NHS News Feed - August 5, 2014 Category: Consumer Health News Tags: Medication Neurology Source Type: news

Raltegravir Not Better Than NRTIs for Refractory HIVRaltegravir Not Better Than NRTIs for Refractory HIV
Raltegravir showed no benefits over nucleoside reverse-transcriptase inhibitors when used in combination with a protease inhibitor as second-line HIV therapy. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 23, 2014 Category: Consumer Health News Tags: HIV/AIDS News Source Type: news

FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine
Dateline City: WHITEHOUSE STATION, N.J. If Approved, Fixed-Dose Combination Would Be Used with Other Antiretroviral Agents for the Treatment of HIV-1 in Adults, Adolescents and Certain Pediatric Patients Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the New Drug Application (NDA) for a fixed-dose combination (FDC) of raltegravir with lamivudine for the treatment of HIV-1 infection (MK-0518B) has been accepted for standard review by the U.S. Food and Drug Administration (FDA). Language: English ...
Source: Merck.com - Research and Development News - June 24, 2014 Category: Pharmaceuticals Tags: Research and Development News Source Type: news

First Patient Enrolled in New Phase 3 Trial Program Investigating a Once-Daily Dosing Regimen of ISENTRESS® (raltegravir)
Dateline City: WHITEHOUSE STATION, N.J. ONCEMRK Study Globally Enrolling Treatment-Naïve Adults with HIV-1 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the first patient has been enrolled in the company’s global Phase 3 clinical trial, ONCEMRK. ONCEMRK is assessing a once-daily investigational formulation of ISENTRESS® (raltegravir), known as reformulated raltegravir, as part of combination HIV therapy for treatment-naïve HIV-1-i...
Source: Merck.com - Research and Development News - June 5, 2014 Category: Pharmaceuticals Tags: Research and Development News Corporate News Latest News Source Type: news

Human endogenous retrovirus (HERV) research
A pilot study of an anti-human endogenous retrovirus antibody suggests it is safe and has some effect on MS (no progression in 7 people over 12 months). Another related study being into an anti-HIV drug called raltegravir (Isentress) is expected to report by the end of the year. MedPage Today Latest MS research updates (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - April 29, 2014 Category: Neurology Source Type: news

Merck Announces First-Quarter 2014 Financial Results
Dateline City: WHITEHOUSE STATION, N.J. First-Quarter 2014 Non-GAAP EPS of $0.88, Excluding Certain Items; GAAP EPS of $0.57; Confirms 2014 Full-Year Non-GAAP EPS Target of $3.35 to $3.53, Excluding Certain Items; GAAP EPS Range of $2.15 to $2.47 Worldwide Sales were $10.3 Billion, a Decrease of 4 Percent, Reflecting Unfavorable Impact of Patent Expiries and a 2 Percent Unfavorable Impact from Foreign Exchange Strategic Initiatives Drove Cost Reductions and Portfolio Divestitures, Generating First-Quarter 2014 Benefits ...
Source: Merck.com - Financial News - April 29, 2014 Category: Pharmaceuticals Tags: Financial News Latest News Source Type: news

FDA Updates Raltegravir (Isentress) Labeling
“On April 8, 2014 FDA approved updates to the Isentress (raltegravir) label to include information regarding co-adminsitration of raltegravir with boceprevir or telaprevir. “In drug interaction studies, raltegravir did not have a clinically meaningful effect on the pharmacokinetics of telaprevir or boceprevir. No dose adjustment is required for Isentress or boceprevir or telaprevir.” The revised label is available at the FDA website. More information is available: FDA: Press release AIDSinfo: Raltegravir (Isentress) patient fact sheet (Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS ...
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) - April 11, 2014 Category: Infectious Diseases Source Type: news

3 Regimens Hold HIV in Check Without Efavirenz
BOSTON (MedPage Today) -- Three different regimens for treating HIV patients -- one using the twice daily integrase inhibitor raltegravir (Isentress) and two based with ritonavir-boosted protease inhibitors -- effectively suppressed the virus, researchers said here. (Source: MedPage Today Gastroenterology)
Source: MedPage Today Gastroenterology - March 8, 2014 Category: Gastroenterology Source Type: news

Raltegravir Combo Gives New Anti-HIV Alternative
BOSTON (MedPage Today) -- The use of a two-drug anti-HIV therapy of raltegravir (Isentress) plus darunavir (Prezista) appeared to be non-inferior to tenofovir/emtricitabine (Truvada) plus darunavir, researchers reported here. (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - March 6, 2014 Category: Consumer Health News Source Type: news

New 96-Week ACTG Study Results Presented at CROI 2014; First Large Study Comparing ISENTRESS® (raltegravir) Regimen to Two Protease Inhibitor Regimens in Previously Untreated Adults with HIV-1
Dateline City: BOSTON BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, said today that in a new 96-week, open-label AIDS Clinical Trials Group (ACTG) study designed to compare three different NNRTI-sparing HIV regimens in treatment-naïve patients – one containing Merck’s twice-daily ISENTRESS® (raltegravir) and two containing different once-daily ritonavir-boosted protease inhibitors, atazanavir and darunavir -- all three regimens achieved high and equivalent levels of efficacy, as measured by time t...
Source: Merck.com - Research and Development News - March 5, 2014 Category: Pharmaceuticals Tags: Research and Development News Source Type: news

New 96-Week ACTG Study Results Presented at CROI 2014; First Large Study Comparing ISENTRESS® (raltegravir) Regimen to Two Protease Inhibitor Regimens in Previously Untreated Adults with HIV-1
Dateline City: BOSTON BOSTON--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, said today that in a new 96-week, open-label AIDS Clinical Trials Group (ACTG) study designed to compare three different NNRTI-sparing HIV regimens in treatment-naïve patients – one containing Merck’s twice-daily ISENTRESS® (raltegravir) and two containing different once-daily ritonavir-boosted protease inhibitors, atazanavir and darunavir -- all three regimens achieved high and equivalent levels of efficacy, as measured by time to...
Source: Merck.com - Product News - March 5, 2014 Category: Drugs & Pharmacology Tags: Prescription Medicine News Corporate News Latest News Source Type: news

Cipla to market MSD's HIV drug 'raltegravir' in India
MSD in India Managing Director K G Ananthakrishnan said the partnership is aligned with the company's commitment towards patients in India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - February 20, 2014 Category: Pharmaceuticals Source Type: news

Merck Announces Fourth-Quarter and Full-Year 2013 Financial Results
Dateline City: WHITEHOUSE STATION, N.J. Fourth-Quarter 2013 Non-GAAP EPS Increased by 6 Percent Over Prior Year to $0.88, Excluding Certain Items; GAAP EPS Decreased by 13 Percent to $0.26. Full-Year 2013 Non-GAAP EPS of $3.49, Excluding Certain Items; GAAP EPS of $1.47. Fourth-Quarter 2013 Worldwide Sales Were $11.3 Billion, a Decrease of 4 Percent Reflecting Unfavorable Impact of Patent Expiries and a 3 Percent Negative Impact from Foreign Exchange. Full-Year 2013 Worldwide Sales Were $44.0 Billion, a Decrease of 7 Percent ...
Source: Merck.com - Corporate News - February 5, 2014 Category: Pharmaceuticals Tags: Corporate News Financial News Latest News Source Type: news

FDA Clears New Formulation of Raltegravir for Infants FDA Clears New Formulation of Raltegravir for Infants
The oral suspension formulation of the HIV integrase inhibitor may be used in patients as young as 4 weeks of age. FDA Approvals (Source: Medscape Hiv-Aids Headlines)
Source: Medscape Hiv-Aids Headlines - January 11, 2014 Category: Infectious Diseases Tags: HIV/AIDS News Alert Source Type: news

Merck Receives FDA Approval for ISENTRESS® (raltegravir) for Pediatric Oral Suspension
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) recently approved ISENTRESS® for oral suspension, a new pediatric formulation of Merck’s integrase inhibitor. With this approval, ISENTRESS is now indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients four weeks of age and older. Language: English Conta...
Source: Merck.com - Corporate News - January 8, 2014 Category: Pharmaceuticals Tags: Prescription Medicine News Corporate News Latest News Source Type: news

FDA Approves Oral Suspension Form of Raltegravir
“On December 20, 2013, FDA approved a new dosage form, ISENTRESS® (raltegravir) for oral suspension, in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients 4 weeks of age and older, weighing at least 3 kg to less than 20 kg. This also includes a new Instructions for Use document as part of the patient labeling.” The updated labeling will be available at the FDA website. More information is available: FDA: Press release (Source: AIDSinfo At-a-Glance: Offering Information on HIV/AIDS Treatment, Prevention, and Research, A Service of the U.S. Department ...
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 3, 2014 Category: Infectious Diseases Source Type: news

Raltegravir + FTC/TDF as HIV nPEP in MSMRaltegravir + FTC/TDF as HIV nPEP in MSM
This study investigates the safety, adherence and tolerability of RAL in a 3-drug combination for HIV nonoccupational post-exposure prophylaxis in men who have sex with men. HIV Medicine (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - December 30, 2013 Category: Consumer Health News Tags: HIV/AIDS Journal Article Source Type: news