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Matrix Laboratories receives tentative FDA approval for its NDA

Mylan Inc. today announced that its privately held Indian 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 Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 600 mg/300 mg/300 mg.

16 Sep 2009

MSD's ISENTRESS approved by the EU Commission for treating HIV-1 infection in adult patients

Merck Sharp & Dohme Limited (MSD) announced today that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as treatment-experienced adult patients.

15 Sep 2009

Phase II VICTOR-E1 clinical study results reported

Schering-Plough Corporation today reported long-term data with vicriviroc, its investigational CCR5 receptor antagonist, from an ongoing, open-label extension of the Phase II VICTOR-E1 study in treatment-experienced HIV-infected patients.

15 Sep 2009

Phase III STARTMRK clinical study on ISENTRESS in comparison to efavirenz

ISENTRESS , an integrase inhibitor from Merck & Co., Inc., was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels (less than 50 copies/mL) and at improving CD4 cell counts in previously untreated (treatment-naïve) HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK.

14 Sep 2009

Tobira Therapeutics presents TBR-652 in vitro data for treating HIV at the 49th ICAAC

Tobira Therapeutics Inc., a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced results from an in vitro study evaluating TBR-652 in combination with lopinavir (LPV), darunavir (DRV), atazanavir (ATV), tenofovir (TDF), etravirine (ETV), and raltegravir (RAL) using the infectious replicative assay deCIPhR.

14 Sep 2009

New kind of “molecular condom” to protect women from AIDS

University of Utah scientists developed a new kind of “molecular condom” to protect women from AIDS in Africa and other impoverished areas. Before sex, women would insert a vaginal gel that turns semisolid in the presence of semen, trapping AIDS virus particles in a microscopic mesh so they can’t infect vaginal cells.

10 Aug 2009

Clinton Foundation reaches deal with Matrix, Pfizer to cut prices for second-line Arvs, TB drug

Former President Bill Clinton on Thursday announced deals with drugmakers Matrix Laboratories and Pfizer to lower the cost of medications to treat patients with drug-resistant forms of HIV/AIDS in the developing world, Reuters reports (Honan, 8/6).

7 Aug 2009

Bill Clinton, Pfizer, and Mylan announce new agreements to lower prices of antiretrovirals for HIV/AIDS in the developing world

President Bill Clinton announced two important and complementary agreements today to enable better, more affordable treatments for patients on second-line antiretroviral (ARV) therapy for HIV/AIDS in the developing world.

6 Aug 2009

Schering-Plough expands Vicriviroc study in treatment-naive patients with HIV

Schering-Plough Corporation has announced that it has extended to stage two an ongoing Phase II clinical study with vicriviroc, its investigational CCR5 antagonist, for use in first-line therapy of adult treatment-naive HIV-infected patients with R5-type virus only. In this study, vicriviroc is being evaluated in a novel nucleoside-sparing regimen that is designed to provide additional options for treatment-naive patients in a once daily regimen, while preserving other drug classes for subsequent lines of treatment.

15 Jul 2009

Early retroviral use best for AIDS patients with serious complications

HIV-positive patients who don't seek medical attention until they have a serious AIDS-related condition can reduce their risk of death or other complications by half if they get antiretroviral treatment early on, according to a new multicenter trial led by researchers at the Stanford University School of Medicine.

17 May 2009

Gilead Sciences announces notification of ANDA filing for Atripla

Gilead Sciences, Inc. has 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 Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Atripla is currently sold in the United States through a joint venture between Bristol-Myers Squibb and Gilead.

6 Apr 2009

Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.

30 Mar 2009

Genetic screening effective for initial HIV treatment

A major study from a team of researchers from Weill Cornell Medical College and Massachusetts General Hospital has found that a recent change to HIV-treatment guidelines recommending genetic screening is cost-effective under certain conditions. The new recommendation suggests conducting a genetic screening test prior to prescribing the drug abacavir, one of the preferred first-line drugs for the treatment for HIV-infected adults.

17 Sep 2008

Eastern Virginia Medical School receives $100 million grant from USAID for microbicide research

Eastern Virginia Medical School on Monday announced that it has received a $100 million grant from USAID for microbicide research through its CONRAD program, the Virginian-Pilot reports.

10 Sep 2008

Gilead's antiretroviral patent request rejected by Brazil

A patent request from the pharmaceutical company Gilead for its antiretroviral drug tenofovir was rejected by Brazil Wednesday, Reuters reports.

4 Sep 2008

Viread approved for chronic hepatitis B

The FDA has approved Viread (tenofovir disoproxil fumarate) as a treatment option for adults with chronic hepatitis B, a serious liver disease.

11 Aug 2008

Gilead initiates phase III trial of Elvitegravir

Gilead Sciences, Inc. has announced that it has begun enrolling patients in a Phase III clinical trial of its investigational antiretroviral agent elvitegravir (GS 9137), a novel oral integrase inhibitor that is being evaluated for the treatment of HIV-1 infection.

22 Jul 2008

Researchers to compare common ARV as a pill and vaginal gel in unique HIV prevention study

In battle with an epidemic that has outpaced nearly all efforts to contain it, researchers are turning to strategies centered on the same antiretroviral (ARV) drugs that have been used successfully to treat HIV in hopes they will be as effective a stronghold for preventing the virus.

9 Jul 2008

Brazilian organization files opposition to Gilead's antiretroviral patent application in India

The Brazilian group Interdisciplinary AIDS Association, or ABIA, has joined Indian patient advocacy groups to oppose a patent application for Gilead Science's antiretroviral drug Tenofovir, saying that the patent would have a direct impact on Brazil's ability to produce and access affordable generic versions of the drug, India's Business Standard reports. Opponents of the patent say that the drug consists of a previously known compound and, therefore, cannot be patented under India's Patents Act.

2 Jul 2008

U.S. Patent Office confirms second of four Viread patents

Gilead Sciences, Inc. has announced that the U.S. Patent & Trademark Office (PTO) has completed the second of four reexamination proceedings and has confirmed the patentability of U.S. Patent No. 5,922,695, which covers the composition of matter for Viread (tenofovir disoproxil fumarate). On May 20, Gilead announced that the U.S. PTO confirmed the patentability of U.S. Patent No. 6,043,230.

2 Jun 2008