Emtricitabine, also known as Emtriva or FTC, 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. Emtricitabine in capsule form was approved by the FDA on July 2, 2003, for use with other antiretroviral agents in the treatment of HIV infection in adults. Emtricitabine oral solution was approved by the FDA on September 28, 2005, and is now approved for use with other anti-HIV drugs in the treatment of HIV-1 infection in patients older than 3 months of age. This medicine does not cure or prevent HIV infection or AIDS and does not reduce the risk of passing the virus to other people.
Shionogi-ViiV Healthcare LLC today announced that it will be progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572) into Phase III clinical trials. '572 will be the only once-daily, unboosted integrase inhibitor in Phase III clinical development.
Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.
"This is a historic day for HIV prevention research. The CAPRISA 004 results are the first clinical evidence that a microbicide gel can help to prevent sexual transmission of HIV infection," said AVAC Executive Director Mitchell Warren, reacting to the results of the landmark microbicide trial presented today at the International AIDS Conference in Vienna.
Abbott today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada® (tenofovir and emtricitabine) in antiretroviral-naive adult patients. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study.
Melbourne-based biotech Avexa has announced the closure of its lead HIV program for apricitabine after failing to attract a licensing partner for the Phase III drug.
Gilead Sciences, Inc. today announced that the company's Board of Directors has authorized the repurchase of up to $5 billion of the company's common stock through May 2013.
Gilead Sciences, Inc. announced today it has obtained data supporting bioequivalence of a formulation of the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride, 25 mg).
Gilead Sciences, Inc. provided an update today on the development of the fixed-dose combination of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride, 25 mg).
Gilead Sciences, Inc. today announced that it has dosed the first patient in the Phase III clinical program evaluating its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat (formerly GS 9350), emtricitabine and tenofovir disoproxil fumarate.
The Emory Institute of Drug Discovery and Zirus, Inc., a biotechnology company based in Buford, Georgia, have entered into a collaboration and research agreement to develop novel compounds to treat infectious disease. Zirus uses a proprietary method for identifying genes and gene products in host cells that, when blocked, can prevent viruses from multiplying. Over the past several years, either alone or in collaboration with partners, including the Centers for Disease Control and Prevention (CDC), Zirus has identified, licensed and filed patents on more than 1000 targets.
At the 17th Conference on Retroviruses and Opportunistic Infections (CROI), ViiV Healthcare presented new data across its broad range of investigational and current medicines for the treatment of HIV/AIDS. Highlighted data at the conference included an oral presentation on the investigational integrase inhibitor, S/GSK1349572, as well as data presentations on SELZENTRY® (maraviroc) and EPZICOM® (abacavir/lamivudine).
Gilead Sciences, Inc. announced Phase II clinical trial results today showing that its investigational fixed-dose single-tablet “Quad” regimen of elvitegravir, GS 9350 (cobicistat) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection exhibited antiretroviral activity comparable to that of Atripla® (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).
Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for PREZISTA® (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN studies.
Gilead Sciences, Inc. today announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Viread® (tenofovir disoproxil fumarate).
Gilead Sciences, Inc. today announced that a Phase II clinical trial of its investigational integrase inhibitor-based, once-daily, fixed-dose “Quad” regimen of elvitegravir, GS 9350 and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV-1 infection met its primary objective.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in 2018, the fixed dose coformulation of Tibotec's rilpivirine and Gilead's Truvada will achieve blockbuster sales of more than $2 billion in the HIV drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
IP Overview HIV Therapy 2009” ( www.frinnov.fr/en/ip-overview/sciences-de-la-vie/hiv-therapy-2.html ) establishes a panorama of the patents claiming “HIV and AIDS treatments” and analyses the key and emerging thematic and the strategic positions of the actors involved in this sector. In order to fully analyze this field, the information coming from 6800 published patents and patent applications was aggregated.
Gilead Sciences, Inc. today announced the presentation of three-year (144-week) open label data from two pivotal Phase III clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread® (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.
Merck Frosst Canada Ltd. is pleased to announce that (Pr)ISENTRESS(R) (raltegravir) is now indicated for use in treatment-naïve HIV-1 infected adults in combination with other antiretroviral agents.
Johnson & Johnson today announced sales of $15.1 billion for the third quarter of 2009, a decrease of 5.3% as compared to the third quarter of 2008. Operational results declined 2.8% and the negative impact of currency was 2.5%. Domestic sales declined 8.1%, while international sales declined 2.5%, reflecting operational growth of 2.4% and a negative currency impact of 4.9%.