Latest Abacavir Stories

TITUSVILLE, N.J., Dec. 10, 2012 /PRNewswire/ -- 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....

PITTSBURGH and HYDERABAD, India, Aug. 2, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) 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. Emtricitabine is marketed by Gilead under the brand name Emtriva(®), and a...

LONDON, July 11, 2012 /PRNewswire/ -- 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. The study demonstrated superiority of the dolutegravir-based regimen compared to the single tablet regimen Atripla®. At 48 weeks, 88% of study participants on the dolutegravir regimen were virologically suppressed (<50...

Researchers identify mechanism key in drug allergy 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....

Research links abacavir hypersensitivity reactions to attacks by body's own immune system 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. AIDS is published by Lippincott Williams & Wilkins, a part of Wolters...

PITTSBURGH, Feb. 23, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Abacavir Sulfate and Lamivudine Tablets, 60 mg/30 mg. This fixed-dose combination (FDC) product was developed for use in treating children...

PITTSBURGH, Dec. 20, 2011 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization's (WHO) Prequalification of Medicines Programme. The products include: Atazanavir Capsule, 300 mg, Ritonavir Tablet, 100 mg (heat-stable), and Tenofovir Disoproxil Fumarate and Lamivudine...

TITUSVILLE, N.J., July 19, 2011 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP, presented today 96-week findings from two pivotal Phase 3 clinical trials, known as ECHO and THRIVE, comparing the efficacy, safety and virology profile of its non-nucleoside reverse transcriptase inhibitor (NNRTI) EDURANT(TM) (rilpivirine) tablets versus efavirenz (EFV) in antiretroviral treatment-naive, HIV-1-infected adults. The pooled analysis at 96 weeks showed that 78 percent of...

TITUSVILLE, N.J., May 20, 2011 /PRNewswire/ -- The US Food and Drug Administration (FDA) today approved EDURANT(TM) (rilpivirine) tablets for use in combination with other antiretroviral agents (ARVs) in the treatment of human immunodeficiency virus type 1 (HIV-1) in adults who have never taken HIV therapy (treatment-naive). (Photo: http://photos.prnewswire.com/prnh/20110520/SF06258) EDURANT (pronounced ee' dur ant) was developed as TMC278 (rilpivirine) by Tibotec Pharmaceuticals and is...

LONDON, Feb. 3, 2011 /PRNewswire/ -- Shionogi-ViiV Healthcare, LLC announced today that the first patient has entered the clinical study, SINGLE (ING114467), designed to support a new fixed-dose combination (FDC) therapy for the treatment of HIV. The new investigational regimen, known as 572-Trii, will combine the investigational integrase inhibitor S/GSK1349572 ('572) and ViiV Healthcare's combination nucleoside reverse transcriptase inhibitor (NRTI) Kivexa®/Epzicom® (ABC/3TC)....