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.
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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. Departmen...
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
Merck Announces Third-Quarter 2013 Financial Results
Dateline City:
WHITEHOUSE STATION, N.J.
2013 Third-Quarter Non-GAAP EPS of $0.92, Excluding Certain Items; GAAP EPS of $0.38
Worldwide Sales were $11.0 Billion, a Decrease of 4 Percent Reflecting the Unfavorable Impact of Patent Expiries and a 2 Percent Negative Impact from Foreign Exchange
Strong Growth in Vaccines and Immunology as well as ISENTRESS
‘Breakthrough Therapy’ Designation Granted for MK-5172/MK-8742, in Development for ...
Source: Merck.com - Corporate News - October 28, 2013 Category: Pharmaceuticals Tags: Corporate News Financial News Latest News Source Type: news
Merck Presents New Pharmacokinetic Data on ISENTRESS® (raltegravir) at 14th European AIDS Conference
Dateline City:
WHITEHOUSE STATION, N.J.
Company Confirms Development Program for Investigational Once Daily (QD) Dosing Regimen of ISENTRESS
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, is
presenting pharmacokinetic data this week on investigational
formulations of a once daily (QD) dose of ISENTRESS at the 14th
European AIDS Conference (EACS), sponsored by the European AIDS Clinical
Society. The me...
Source: Merck.com - Product News - October 16, 2013 Category: Drugs & Pharmacology Tags: Prescription Medicine News Research and Development News Corporate News Latest News Source Type: news
Merck R&D Head Bets Slashing Bureaucracy Will Unlock Innovation
Roger Perlmutter When Merck scientist Chris Hill won an award from the American Chemical Society for creating the molecule that become the AIDS drug Isentress, he claimed that it is harder to bring a new drug to market than to put a man on the moon. Hearing of the comment on (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - September 19, 2013 Category: Pharmaceuticals Authors: Matthew Herper Source Type: news
Isentress in Post-Exposure Therapy Shows Improved Tolerability, Adherence
When the U.S. Prevention Health Services (USPHS) updated their occupational post-exposure prophylaxis (PEP) guidelines in August -- endorsing the use of three or more antiretrovirals (ARVs) as the standard-of-care for healthcare workers -- it suggested to us that similar changes might soon be employed in cases of non-occupational PEP, where two or more drugs are used....Read Full Post (Source: About AIDS / HIV)
Source: About AIDS / HIV - September 16, 2013 Category: Consumer Health News Source Type: news
FDA Approves Dolutegravir, a New Drug to Treat HIV-1 Infection
“The U.S. Food and Drug Administration today [August 12, 2013] approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
“Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.
“Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), includ...
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) - August 16, 2013 Category: Infectious Diseases Source Type: news
Why We're Excited About the New HIV Drug, Tivicay
GlaxoSmithKline's long-awaited integrase inhibitor-class drug, Ticivay (dolutegravir), received approval on Monday from the U.S. Food and Drug Administration. The once-daily HIV treatment is the third drug of its class to receive FDA approval, following in the footsteps of Isentress (raltegravir) in 2007 and elvitegravir (a component of the "quad pill," Stribild) in 2012....Read Full Post (Source: About AIDS / HIV)
Source: About AIDS / HIV - August 13, 2013 Category: Consumer Health News Source Type: news
Merck Reaffirms Commitment to State AIDS Drug Assistance Programs (ADAPs) Through 2014
Dateline City:
WHITEHOUSE STATION, N.J.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and the ADAP Crisis Task Force (ACTF) today announced that the company will extend its commitment to support state AIDS Drug Assistance Programs (ADAPs), which have struggled to meet growing needs in recent years due to funding shortfalls. Through the new agreement, which extends through Dec.
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read more (Source: Merck.com - Product News)
Source: Merck.com - Product News - July 29, 2013 Category: Drugs & Pharmacology Authors: Maria.tortoreto at merck.com Tags: ACTF Isentress Merck MRK MSD NASTAD Prescription Medicine News Corporate News Corporate Responsibility News Latest News Source Type: news
Investigational HIV Treatment Promising (CME/CE)
KUALA LUMPUR (MedPage Today) -- The investigational anti-HIV drug dolutegravir outperformed raltegravir (Isentress) in a randomized trial, a researcher said here. (Source: MedPage Today State Required CME)
Source: MedPage Today State Required CME - July 3, 2013 Category: Consumer Health News Source Type: news
Generic Competition Pushing Down HIV Drug Prices, But Patents Keep Newer Drugs Unaffordable
Myanmar 2012 © Greg Constantine
A patient collects her medication from the pharmacy at an MSF clinic in Yangon, where MSF treats HIV/AIDS and TB.
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KUALA LUMPUR/NEW YORK, JULY 2, 2013—The price of first- and second-line antiretrovirals (ARVs) to treat HIV are falling because of increased competition among generic producers, but newer ARVs continue to be priced astronomically high, according to the annual report Untangling the Web of ARV Price Reductions, released today by the international medical humanitarian or...
Source: MSF News - July 3, 2013 Category: Global & Universal Source Type: news
FDA Approves New U.S. Labeling For ISENTRESS® (Raltegravir)
Merck (NYSE: MRK), known as MSD outside the United States and Canada, have announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for ISENTRESS® (raltegravir) Film-coated Tablets, Merck's integrase inhibitor for the treatment of HIV-1 infection in adult patients as part of combination HIV therapy. The updated prescribing information now includes 240-week results from the STARTMRK study, the longest double-blind Phase III non-inferiority study evaluating an integrase inhibitor in treatment-naïve adult patients with HIV-1 infection... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - July 3, 2013 Category: Consumer Health News Tags: Regulatory Affairs / Drug Approvals Source Type: news
FDA Approves New U.S. Labeling for ISENTRESS® (raltegravir) to Include 240-Week Results from STARTMRK Study of ISENTRESS Containing Regimen in Previously Untreated HIV-1 Infected Adult Patients
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) has
approved new labeling for ISENTRESS® (raltegravir)
Film-coated Tablets, Merck’s integrase inhibitor for the treatment of
HIV-1 infection in adult patients as part of combination HIV therapy.
Language:
English
Contact:
...
Source: Merck.com - Product News - July 1, 2013 Category: Drugs & Pharmacology Authors: hq_site_admin Tags: Prescription Medicine News Corporate News Latest News Source Type: news
Mathematical Model Measures Hidden HIV Virus Replication
Scientists have long believed that measuring the amount of HIV in a person's blood is an indicator of whether the virus is actively reproducing. A University of Delaware-led research team reports new evidence that hidden virus replication may be occurring within the body's tissue, despite undetectable virus levels in the blood. The findings were reported in the Journal of the Royal Society Interface in a paper titled "Modelling HIV-1 2-LTR dynamics following raltegravir intensification... (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - May 10, 2013 Category: Consumer Health News Tags: HIV / AIDS Source Type: news
