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29/01/2015
U.S. Food and Drug Administration approves Bristol-Myers Squibb’s Evotaz™ (atazanavir and cobicistat) for the treatment of HIV-1 infection in adults

Evotaz is the first and only protease inhibitor pharmacoenhanced by cobicistat that is supported by comparative Phase III clinical trial data Evotaz is the only protease inhibitor pharmacoenhanced by cobicistat with virologic failure rates as low as 6% [HIV-1 RNA ≥50 copies/mL at 48 weeks: 6% Evotaz arm; 4% Reyataz ®...

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Tags: Treatment, FDA




29/01/2015
PREZCOBIX™ (darunavir/cobicistat) approved in the U.S. for the treatment of adults living with HIV-1

Combined fixed-dose tablet of darunavir and cobicistat can help reduce number of pills in a combination antiretroviral treatment regimen TITUSVILLE, N.J. , Jan. 29, 2015 -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the U.S. Food and Drug Administration (FDA) has approved PREZCOBIX™ (darunavir 800 mg/cobicistat 150 mg)...

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Tags: Treatment, FDA




29/01/2015
Herpes zoster incidence higher among patients with HIV

Despite declining significantly in the era of ART, the incidence of herpes zoster among patients with HIV was still three times that of the general population, according to data published in Clinical Infectious Diseases . “The risk of herpes zoster was associated with the degree of immunodeficiency and was greatly reduced by ART,” researchers from the Institut Pierre...

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Source Source: Healio





29/01/2015
FDA: Approval changes to the Kaletra (lopinavir/ritonavir)

On January 28, 2014 FDA approved changes to the Kaletra (lopinavir/ritonavir) label to include dosing recommendations in pregnant women. The main additions and revisions include the following: 2 DOSAGE AND ADMINISTRATION 2.4 Dosage Recommendations in Pregnancy Administer 400/100 mg of KALETRA twice daily in pregnant patients with no documented lopinavir-associated...

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Source Source: FDA





29/01/2015
Sharing older clinical trial data remains a problem for Pharma

With considerable fanfare, the Institute of Medicine released a long-awaited report last month praising the virtues of sharing clinical trial data. This is an important, but also contentious issue because without access to such information it can be virtually impossible for independent researchers to verify results that can lead to improved treatments, better health care and lower costs....

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