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.
13 hours ago | ViiV Healthcare
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
17 hours ago | Medscape
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.
29 April 2015 | Science Daily
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.
15 April 2015 | Eurekalert Inf Dis
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.
14 April 2015 | ABIVAX press release
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.
13 April 2015 | University of Massacusetts Medical Schoool press release
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.
10 April 2015 | TAG
The new study, conducted in Michel Nussenzweig’s Laboratory of Molecular Immunology, finds that administration of a potent antibody, called 3BNC117, can catch HIV off guard and reduce viral loads.
09 April 2015 | Rockefeller University press release
Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.
08 April 2015 | Gilead press release
Scientists at Emory University, in partnership with the pharmaceutical company Bristol-Myers Squibb, have found compounds that block the human CCR5 and CXCR4 co-receptors for HIV and also HIV reverse transcriptase, an enzyme that’s key to the virus’s ability to copy itself.
24 March 2015 | American Chemical Society