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Gilead Submits New Drug Application to U.S. Food and Drug Administration for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen that combines Gilead’s emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF) from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen.

Published
02 July 2015
From
Gilead press release
New British guidelines recommend treatment for everyone with HIV

Everyone with HIV who is prepared to take antiretroviral treatment should receive it, regardless of CD4 cell count, new draft British HIV Association (BHIVA) treatment guidelines

Published
24 June 2015
By
Keith Alcorn
European Medicines Agency Validates Gilead’s Marketing Application for Fixed-Dose Combination of Emtricitabine and Tenofovir Alafenamide (F/TAF) for HIV Treatment

Gilead Sciences, Inc. today announced that the company’s Marketing Authorization Application (MAA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) has been fully validated and is now under evaluation by the European Medicines Agency (EMA). - See more at: http://www.gilead.com/news/press-releases/2015/5/european-medicines-agency-validates-gileads-marketing-application-for-fixeddose-combination-of-emtricitabine-and-tenofovir-alafenamide-for-hiv-treatment?#sthash.jLacUtX1.dpuf

Published
02 June 2015
From
Gilead
ViiV Healthcare and CHAI collaboration delivers second milestone with first filing with the FDA of generic dolutegravir by Aurobindo Pharma for the treatment of HIV

ViiV Healthcare, Aurobindo Pharma, and the Clinton Health Access Initiative, Inc. (CHAI) announced today that Aurobindo Pharma has submitted an Abbreviated New Drug Application (ANDA) for dolutegravir 50mg, for Tentative Approval, to the Food and Drug Administration (FDA), for the treatment of HIV. This is the first ANDA for a generic version of dolutegravir, less than two years after FDA approval of Tivicay® (dolutegravir) for sale in the United States. Upon receiving Tentative Approval from the FDA, Aurobindo Pharma will be able to supply dolutegravir 50mg via the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, following completion of required local regulatory approval process, in the licensed countries outside of the United States, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014.

Published
26 May 2015
From
ViiV Healthcare
EMA Panel Recommends Evotaz for Adults With HIV-1

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended granting marketing authorization for atazanavir/cobicistat (Evotaz, Bristol-Myers Squibb Pharma EEIG) for the treatment of adults with HIV-1 infection and no known mutations associated with atazanavir resistance

Published
26 May 2015
From
Medscape
New subdermal implant delivers potent antiretroviral drugs

A novel, subdermal implant delivering potent antiretroviral drugs shows extreme promise in stopping the spread of HIV, researchers report. Scientists say that they have developed a matchstick size implant, similar to a contraceptive implant, that successfully delivers a controlled, sustained release of tenofovir alafenamide up to 40 days in dogs with no adverse side effects.

Published
29 April 2015
From
Science Daily
Six questions about HIV/AIDS that deserve more attention

As HIV investigators work to control and eradicate the virus worldwide, certain myths or misconceptions about the disease have been embraced, whereas other concepts with merit have been left relatively unexplored, argues American HIV/AIDS researcher Jay Levy, M.D., in a Trends in Molecular Medicine commentary. He calls on fellow researchers to continue questioning and not to lose sight of alternative strategies that could ultimately lead to a sustainable, long-term solution to HIV infection.

Published
15 April 2015
From
Eurekalert Inf Dis
Mechanism of action of ABIVAX’s First-in-class anti-HIV drug published today in peer-reviewed journal Retrovirology

ABX464 blocks viral replication by preventing the export of viral RNA from the nucleus to the cytoplasm in infected cells. This transport is normally mediated by a viral protein called Rev, and the activity of Rev is efficiently inhibited by ABX464. Never targeted before, Rev has been postulated of potential interest for HIV treatment for some time, but ABX464 is the first molecule under development aimed at inhibiting it.

Published
14 April 2015
From
ABIVAX press release
Editing HIV out of our genome with CRISPR

In an attempt to render latent HIV completely harmless, UMass Medical School researchers are using CRISPR/Cas9, a powerful gene editing tool, to develop a novel technology that can potentially cut the DNA of the latent virus out of an infected cell.

Published
13 April 2015
From
University of Massacusetts Medical Schoool press release
Broadly Neutralizing Antibody Suppresses HIV in Clinical Trial

There is now intense interest in learning whether the blossoming array of broadly neutralizing antibodies (bNAbs) can be put to therapeutic and preventive use. A paper published yesterday in Nature describes encouraging results from a phase I trial involving the bNAb 3BNC117. Reflecting the level of interest in the topic, the paper has attracted extensive press coverage.

Published
10 April 2015
From
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