Reverse Transcriptase News and Research

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Rate of antiretroviral virological failure higher among children living with HIV/AIDS than adults, study finds

One in eight children living with HIV/AIDS "experiences triple-class virological failure - meaning the virus becomes resistant to multiple drugs - within five years of starting antiretroviral treatment," according to a study published Wednesday in the Lancet, HealthDay News/MSN reports. The "failure rate is higher than in adults and highlights the challenge of maintaining viral load suppression in young patients who begin antiretroviral therapy so early in life, the researchers said," according to the news service (Preidt, 4/19).

21 Apr 2011

Adamis acquires cancer vaccine technology from UCSD

Adamis Pharmaceuticals Corporation (OTCBB: ADMP) today announced the completion of the acquisition of a unique patented cancer vaccine technology from the Regents of the University of California.

20 Apr 2011

Increased risk of virologic failure associated with NNRTI-based regimens in HIV-1 drug resistance mutations

An analysis of data from 10 studies indicates that the presence of low frequency (also called "minority") human immunodeficiency virus type 1 (HIV-1) drug resistance mutations, particularly those involving nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance, are significantly associated with an increased risk of first-line antiretroviral treatment failure, according to an article in the April 6 issue of JAMA.

6 Apr 2011

FDA approves Matrix NDA for Zidovudine Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration under the President's Emergency Plan for AIDS Relief for its New Drug Application for Zidovudine Tablets, 100 mg.

10 Mar 2011

Viruses that are natural part of human genome may retrovirus culprit

A retrovirus that inserted itself into the human genome thousands of years ago may be responsible for some cases of the neurodegenerative disease amyotrophic lateral sclerosis (ALS), also known as Lou Gherig’s disease. The finding, made by Johns Hopkins scientists, may eventually give researchers a new way to attack this universally fatal condition.

2 Mar 2011

Genomic Health to present prostate cancer studies at ASCO Genitourinary Cancer Symposium

Genomic Health, Inc. today announced the presentation of two studies at the American Society of Clinical Oncology® (ASCO®) Genitourinary (GU) Cancer Symposium, including complete results from its prostate cancer gene identification study, which identified 295 genes strongly associated with clinical recurrence following radical prostatectomy with great consistency across multiple tumor samples examined in each patient.

17 Feb 2011

Gilead resubmits NDA for single-tablet regimen of Truvada/TMC278

Gilead Sciences, Inc. announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for 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.

10 Feb 2011

Idenix announces updates on HCV and HIV clinical development programs

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.

10 Feb 2011

Shionogi-ViiV Healthcare initiates 572-Trii fixed-dose combination therapy study for HIV

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.

3 Feb 2011

Simple hTERT analysis may provide useful prognostic tool in advanced non-small cell lung cancer

High levels of circulating DNA may indicate faster progression of lung cancer and lower overall survival, according to a study published in the February edition of the Journal of Thoracic Oncology, the official publication of the International Association for the Study of Lung Cancer (IASLC).

1 Feb 2011

Johnson & Johnson deal may bring HIV/AIDS drugs to developing countries faster

Johnson & Johnson's Tibotec Pharmaceuticals unit on Thursday announced it had granted multiple licenses to generic drug manufacturers "to provide copies of [the experimental HIV/AIDS drug rilpivirine hydrochloride] TMC278 in sub-Saharan Africa, India and parts of Asia if it's approved by regulators," Bloomberg Businessweek reports.

1 Feb 2011

Tibotec grants multiple non-exclusive licenses to generic manufacturers for rilpivirine hydrochloride

Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults.

28 Jan 2011

Matrix enters licensing agreement with Tibotec for generic Rilpivirine Hydrochloride

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive license to manufacture, market and distribute a generic version of the non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), pending its regulatory approval for the treatment of treatment-naive HIV-1-infected adults.

28 Jan 2011

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

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 Lamivudine and Zidovudine Tablets, 30 mg/60 mg.

20 Jan 2011

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

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.