Reverse Transcriptase News and Research

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FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Bristol-Myers Squibb, Oncolys complete license agreement for festinavir

Bristol-Myers Squibb Company and Oncolys BioPharma Inc., a privately held biotechnology company based in Japan, announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire exclusive worldwide rights to manufacture, develop and commercialize festinavir, a once-a-day, orally available nucleoside reverse transcriptase inhibitor (NRTI) in Phase II development for HIV.

20 Dec 2010

Matrix's NDA for Abacavir Sulfate receives tentative FDA approval under PEPFAR

Mylan Inc. today announced that its subsidiary 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 Tablets, 60 mg. The NDA is based on the reference listed drug Ziagen® by ViiV Healthcare.

7 Dec 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

ViiV Healthcare awards $20 million to Idenix for GSK2248761 clinical milestone

Idenix Pharmaceuticals, Inc, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company will receive a payment of $20 million from the ViiV Healthcare Company for the achievement of a clinical milestone relating to GSK2248761.

23 Nov 2010

Gilead Sciences third quarter total revenues increase 8% to $1.94 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share.

20 Oct 2010

Johnson & Johnson third quarter sales decrease 0.7% to $15.0 billion

Johnson & Johnson today announced sales of $15.0 billion for the third quarter of 2010, a decrease of 0.7% as compared to the third quarter of 2009. Operational results increased 0.1% and the negative impact of currency was 0.8%. Domestic sales declined 2.5%, while international sales increased 1.1%, reflecting operational growth of 2.6% and a negative currency impact of 1.5%.

19 Oct 2010

Cytheris initiates ORVACS Phase II clinical trial to study HIV infection

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced the initiation of Phase II clinical trial of the company's investigative immunomodulatory agent, CYT107 (rhIL-7), in combination with two potent antiretroviral drugs represented by the integrase inhibitor raltegravir (ISENTRESS- Merck & Co.) and the CCR5 inhibitor, maraviroc (SELZENTRY- ViiV Healthcare).

19 Oct 2010

Phase III study influences WHO to change guidelines for HIV-infected women receiving nevirapine

Findings from a study, which appear in the Oct. 14, 2010 New England Journal of Medicine, helped influence the World Health Organization (WHO) to change its guidelines this year for the treatment of HIV-infected women who receive a single dose of the antiretroviral drug nevirapine to prevent HIV transmission to their babies.

18 Oct 2010

MTN-007 phase trial evaluates vaginal microbicide to prevent rectal transmission of HIV

Tenofovir gel, a vaginal microbicide that has shown promise for preventing HIV through vaginal sex, is being tested in a new trial looking at its safety and acceptability when used rectally. The results of the study, being led by the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), will help determine if the gel should be evaluated further for its potential to prevent HIV among both men and women who engage in receptive anal intercourse.

13 Oct 2010

Researchers discover HIV-1 resists AZT drug

Rutgers researchers have discovered how HIV-1, the virus that causes AIDS, resists AZT, a drug widely used to treat AIDS. The scientists, who report their findings in Nature Structural & Molecular Biology, believe their discovery helps researchers understand how important anti-AIDS treatments can fail and could help AIDS researchers develop more effective treatment for the disease.

20 Sep 2010

Tibotec submits MAA for investigational HIV drug TMC278 to European Medicines Agency

Tibotec Pharmaceuticals today announced its submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for TMC278 (rilpivirine, as hydrochloride), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. The proposed indication would make TMC278 available for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

GoTaq 2-Step RT-qPCR System allows researchers to detect target genes

The new Promega GoTaq 2-Step RT-qPCR System allows researchers to detect target genes expressed at low levels even with hard-to-amplify samples. Enhanced sensitivity of the two-step system extends the broad dynamic range of RNA quantitation and provides a robust, gene expression analysis tool.

11 Aug 2010

VBDS secondary to nevirapine use in HIV-positive, pregnant female: Report

Vanishing bile duct syndrome refers to a group of disorders characterized by destruction and disappearance of intrahepatic (inside the liver) bile ducts. Multiple causes have been identified including infections, malignancies, autoimmune conditions and adverse effects of medications. The usual course of this condition is variable and many patients with VBDS respond to treatment of the underlying condition and/ or removal of the offending agent. However, others progress to cirrhosis and end stage liver disease requiring liver transplantation.

31 Jul 2010

CMX157 shows potential to suppress replication of HIV in Phase 1 clinical trial

Chimerix, Inc., a biopharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of research results demonstrating the potential of CMX157 (hexadecyloxypropyl tenofovir) to effectively suppress replication of human immunodeficiency virus (HIV) that cannot be treated with currently available nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), including tenofovir disoproxil fumarate (Viread), due to the development of multi-drug resistance. Earlier this year, Chimerix initiated a dose-escalating Phase 1 clinical trial of CMX-157 to evaluate drug safety, tolerability and pharmacokinetics.

29 Jul 2010

Tibotec submits NDA for TMC278 anti-HIV compound to FDA

Tibotec Pharmaceuticals today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TMC278 (rilpivirine), an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), being studied for once-daily use with other antiretroviral agents in treatment-naive HIV-1-infected adults. If approved, TMC278 will be the third anti-HIV compound to be introduced by Tibotec Pharmaceuticals.

26 Jul 2010

New HIV drug on the block

Johnson and Johnson’s experimental HIV drug rilpivirine or TMC278, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS. Two clinical trials with the drug has shown that although its effectiveness was same as the existing anti-HIV drugs, its side effects were fewer. On the flip side nearly twice as many patients failed to respond to treatment with the new drug.

22 Jul 2010

Tibotec reports Phase 3 trial results of TMC278 vs. EFV in treatment-naive HIV-1-infected adults

Tibotec Pharmaceuticals announced today results from two pivotal Phase 3, double-blind, randomized clinical trials comparing the efficacy, safety and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus efavirenz (EFV), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naive, HIV-1-infected adults.

22 Jul 2010

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

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.

21 Jul 2010