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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
15 hours ago
From
ViiV Healthcare
Maligned Study on Gay Unions Is Shaking Trust

In 2012, as same-sex marriage advocates were working to build support in California, Michael LaCour, a political science researcher at the University of California, Los Angeles, asked a critical question: Can canvassers with a personal stake in an issue — in this case, gay men and women — actually sway voters’ opinions in a lasting way? Last week, their finding that gay canvassers were in fact powerfully persuasive with people who had voted against same-sex marriage — published in December in Science, one of the world’s leading scientific journals — collapsed amid accusations that Mr. LaCour had misrepresented his study methods and lacked the evidence to back up his findings.

Published
19 hours ago
From
New York Times
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
20 hours ago
From
Medscape
Lower daily tenofovir dose of 150mg safe and effective in people with moderate renal impairment

A reduced tenofovir (Viread) dose of 150mg daily appears to be a safe and effective treatment for people with HIV who have moderate renal impairment, investigators from

Published
22 May 2015
By
Michael Carter
Is Gilead Sciences Its Own Worst Enemy?

Gilead's science is so good that it's actually destroying the company's business. Pharma companies, like most other businesses, make the bulk of their money through repeat business. Gilead, however, is doing something really no other drugmaker is doing -- namely curing patients of devastating infectious diseases.

Published
20 May 2015
From
Motley Fool
HIV immunity: rare gene differences offer hope for treatment

Seven years after the ‘Berlin patient’ was cured of HIV, scientists are looking to natural immunity through genetic variation to create vaccine and gene therapies

Published
12 May 2015
From
The Guardian
GSK team up with US researchers to advance search for HIV cure

Pharmaceutical giant GlaxoSmithKline have partnered with researchers from UNC-Chapel Hill to create a research center that will focus on finding a cure for HIV.

Published
12 May 2015
From
HIV / AIDS News From Medical News Today
Modern NNRTI regimens can be effective with 85% adherence

Some modern HIV treatment regimens can achieve viral suppression with adherence rates as low as 85%, investigators from the US Veteran Aging Cohort Study report in the

Published
12 May 2015
By
Michael Carter
Five antiretroviral combinations associated with increased risk of a cardiovascular event

Treatment with four individual and five combinations of anti-HIV drugs is associated with an increased risk of a cardiovascular event, investigators from the United States report in the

Published
08 May 2015
By
Michael Carter
US guidelines shift to integrase-based combinations for first-line treatment: Atripla relegated due to side effects

The rationale for dropping Atripla is due to concerns about the tolerability of efavirenz, especially the high rate of central nervous system related toxicities. Although this has been a long-standing community concern, DHHS guidelines have consistently recommended efavirenz in previous editions. This tolerability statement is made in the year that efavirenz comes off patent.

Published
06 May 2015
From
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