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Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA

Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults.

Published
22 April 2014
From
Gilead press release
Px Wire: Long-Acting Injectables

In this issue, we review the research on long-acting injectable antiretrovirals for treatment in HIV-positive people and PrEP in HIV-negative people. The pathways for developing these products have key similarities as well as differences—and as the same drugs advance for treatment and PrEP, it will be key to communicate these.

Published
17 April 2014
From
AVAC
Bristol-Myers Squibb Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for People Living with HIV-1

If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is developed by Gilead Sciences, Inc.

Published
15 April 2014
From
Bristol-Myers Squibb press release
Transplant Drugs May Fight HIV Reservoir

Immunosuppressant drugs used to prevent rejction of transplanted organs may combat the HIV reservoir.

Published
14 April 2014
From
AIDSMeds
Nano-sized drug particles to expand HIV treatment further

Research at the University of Liverpool could benefit millions of HIV patients in developing countries through a nano-technology programme aimed at making drug treatment more effective.

Published
09 April 2014
From
Medical Xpress
Long-acting HIV drugs advanced to overcome adherence challenge

If it proves effective, long-acting antiretroviral therapy would set up a new paradigm of monthly or quarterly injectable therapy for some patients. Long-acting drug formulations could solve one of the thorniest problems in HIV management - adherence.

Published
08 April 2014
From
Nature Medicine
Viiv Healthcare licenses dolutegravir (Tivicay) to Medicines Patent Pool

The collaboration with MPP includes two distinct approaches to improve access for adults living with HIV in the developing world: first, a royalty-free voluntary licence in all least-developed, all low-income and all sub-Saharan African countries; second, for specific middle-income countries including India, ViiV Healthcare has established the first-ever MPP licence with a tiered royalty structure, where a small percentage of the sale price is paid based on the gross domestic product (GDP) of the specific country.

Published
02 April 2014
From
Viiv Healthcare press release
Janssen Submits New Drug Application to U.S. FDA for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat as Part of Combination HIV Therapy

"Darunavir is the most prescribed HIV protease inhibitor in the United States and we are excited to be taking this important step in our efforts to offer it with an alternative boosting agent in a fixed-dose combination tablet," said Johan van Hoof, M.D., Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen.

Published
02 April 2014
From
Janssen press release
New NNRTI doravirine matches efavirenz for first-line HIV treatment

The next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine (formerly MK-1439) showed potent antiretroviral activity and good tolerability in combination with tenofovir/FTC (the drugs in Truvada) in a dose-finding

Published
11 March 2014
By
Liz Highleyman
Viral load rebounds in 35% of people using PI/r monotherapy: results of five-year PIVOT study

A long-term strategy study sponsored by the Medical Research Council (MRC) in the UK reported low rates of serious complications and the potential to reduce drug costs. However, more than a third of people on the PI/r monotherapy group had viral load rebound compared to only 3% of people on standard combination therapy.

Published
10 March 2014
From
HIV i-Base
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