Abacavir sulfate, also known as Ziagen or ABC, is a type of medicine called a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs block reverse transcriptase, a protein that HIV needs to make more copies of itself.
Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.
HAAG-STREIT SURGICAL announced its intraoperative-OCT camera has received 510(k) clearance from the U.S. Food and Drug Administration for marketing on the largest medical device market in the world.
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.
ViiV Healthcare announced today that the US Food and Drug Administration has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection.
Dolutegravir has been approved since January 2014 in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus (HIV) infected adults and adolescents above 12 years of age.
Merck, known as MSD outside of the United States and Canada, today announced new data from HIV/HCV co-infected patients in the ongoing C-WORTHY Study, a Phase 2 clinical trial evaluating the efficacy and safety of Merck's all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor.
ViiV Healthcare today announced that the European Commission has approved Tivicay (dolutegravir), an integrase inhibitor, for use in combination with other anti-retroviral medicinal products for the treatment of HIV infected adults and adolescents above 12 years of age.
The drug combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil (elvitegravir fixed combination, trade name: Stribild) has been approved in Germany since May 2013 for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1).
The World Health Organization's new HIV treatment guidelines, released today at the 2013 International AIDS Society Conference, include new antiretroviral therapy recommendations for HIV-infected children, and will mean that more children will be on better treatments.
"GlaxoSmithKline's HIV/AIDS drugs business is to share intellectual property rights on children's medicine in a patent pool designed to make treatments more widely available in poor countries," Reuters reports.
Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a prescribing information update for EDURANT (rilpivirine) tablets to include 96-week pooled data from the Phase 3 ECHO and THRIVE studies, which evaluated the efficacy and safety of EDURANT for the treatment of human immunodeficiency virus type 1 (HIV-1) in antiretroviral treatment-naive adults.
Mylan Inc. today announced the establishment of a new agreement between its subsidiary Mylan Laboratories Limited and Gilead Sciences Inc. Under this agreement, Mylan has licensed the rights to produce and market generic versions of Gilead HIV/AIDS therapies containing Emtricitabine, including single and fixed-dose combinations.
Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.
Included in the 2012 International Antiviral Society-USA panel recommendations for human immunodeficiency virus (HIV) patient care is that all adult patients, regardless of CD4 cell count, should be offered antiretroviral therapy (ART), according to an article in the July 25 issue of JAMA, a theme issue on HIV/AIDS.
On the eve of the XIX International AIDS Conference in Washington, DC, the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, announces a new collaboration with Indian drug manufacturer Cipla to develop and produce an improved first-line antiretroviral (ARV) combination therapy specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS.
Shionogi-ViiV Healthcare LLC today announced that initial results have been received from the Phase III SINGLE (ING114467) study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.
Adverse drug reactions are a major issue that cause harm, are costly and restrict treatment options for patients and the development of new drugs. A groundbreaking finding by researchers from the La Jolla Institute for Allergy & Immunology could lead to a new way to dramatically improve drug safety by identifying drugs at risk to cause potentially fatal genetic-linked hypersensitivity reactions before their use in man.
Potentially severe hypersensitivity reactions to the anti-HIV drug abacavir occur through an autoimmune mechanism, resulting from the creation of drug-induced immunogens that are attacked by the body's immune system, according to a study published online by the journal AIDS, official journal of the International AIDS Society.
A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.
ViiV Healthcare and Shionogi & Co., Ltd. today announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1.