J&J (JNJ) Says FDA Issued CRL for Janssen's 800mg PREZISTA - StreetInsider.com

PREZISTA is always taken with and at the same time as ritonavir with food and in combination with other HIV medicines. Janssen is developing the 800mg tablet dosage strength to allow patients taking PREZISTA once daily to reduce the number of PREZISTA ...

Gilead Files European Marketing Application for Boosting Agent Cobicistat - Yahoo Finance

Currently, ritonavir is the only agent used to boost HIV therapy. Review of the MAA for cobicistat will be conducted under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all 27 member states ...

Safety of Statins - Medscape News

UGT All statins Gemfibrozil, cyclosporine [Corsini and Ceska, 2011; Jacobson, 2009; Law and Rudnicka, 2006] P-glycoprotein Atorvastatin, lovastatin, simvastatin Ritonavir, cyclosporine, verapamil, erythromycin, ketoconazole, itraconazole ...

Gilead Sciences Says MAA For Cobicistat Validated By European Medicines Agency - NASDAQ

Currently, ritonavir is the only agent used to boost HIV therapy, the company said. Gilead said it plans to submit an application for marketing approval of cobicistat to the U.S. Food and Drug Administration in the third quarter of 2012.

FDA Approves New Labeling for ISENTRESS(R) (raltegravir) to Include 1...  - CNBC

Rash occurred more commonly in treatment-experienced subjects receiving regimens containing ISENTRESS plus darunavir/ritonavir, compared to subjects receiving ISENTRESS without darunavir/ritonavir or darunavir/ritonavir without ISENTRESS. However ...

FDA Advisory Committee Supports Approval of Gilead’s Once-Daily Quad Single Tablet Regimen for HIV - Business Wire

and to a regimen containing ritonavir-boosted atazanavir plus Truvada ® (Study 103). The NDA is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of the Quad and the co-formulated single tablet regimen.

FDA Review Positive on Quad Pill for HIV - MedPage Today

The pill was tested against Atripla in one trial and against the ritonavir-boosted protease inhibitor atazanavir (Reyataz), combined with emtricitabine, and tenofovir, in another. In the first trial, 87.6% of quad pill patients reached an ...

The Zacks Analyst Blog Highlights: Gilead Sciences, Abbott Labs, Alliance Data Systems Corporation, Blue Nile and Bristol-Myers Squibb - CNBC

submitted by Gilead in October 2011 for getting Quad approved in the U.S. The NDA included positive data from two late-stage studies - 102 which compared Quad to Atripla and 103 which compared Quad to Norvir (ritonavir)-boosted Reyataz plus Truvada.