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VOICE clinical study for testing the efficacy of two HIV prevention strategies

A new, large-scale clinical trial is examining whether antiretroviral medications normally used to treat HIV infection can also prevent HIV infection in women when applied as a vaginal gel or taken as oral tablets once daily.

16 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

Innexus Biotechnology announces business development initiative on lead preclinical candidate

InNexus Biotechnology Inc. announced today that the Company will embark on a business development initiative for DXL625™ (CD20), the Company’s lead preclinical candidate for the prospective treatment of Non-Hodgkin’s Lymphoma and/or Chronic Lymphocytic Leukemia.

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

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

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

Boehringer, Gilead freeze antiretroviral prices for some U.S. agencies

Pharmaceutical companies Boehringer Ingelheim and Gilead Sciences are freezing the prices of their antiretroviral drugs for select agencies in the U.S., the AIDS Healthcare Foundation announced on Tuesday, Bloomberg reports.

8 Jun 2008

U.S. PTO's rejection of Gilead's antiretroviral patents might affect applications in India

Last week's rejection by the U.S. Patent and Trademark Office of four patents on Gilead Sciences' antiretroviral drug Viread might affect patent applications for the drug in India, the Times of India reports.

28 Jan 2008

Merck to register, lower cost of antiretroviral Atripla in developing countries

Pharmaceutical company Merck on Friday said that it will begin registering the antiretroviral drug Atripla in developing countries and that it will lower the cost of the drug in countries with high HIV prevalence, the Bergen Record reports.

21 Feb 2007

FDA approves Atripla for the treatment of HIV-1 infection in adults

Bristol-Myers Squibb Company and Gilead Sciences have announced the U.S. Food and Drug Administration (FDA) has granted approval of Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) for the treatment of HIV-1 infection in adults.

13 Jul 2006

Approval of fixed-dose combination treatments for HIV-1 infection

The Food and Drug Administration has announced the approvals of Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection.

5 Aug 2004

FDA approves two fixed-dose combination treatments for HIV-1 infection

The Food and Drug Administration has announced approved Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection.

2 Aug 2004