Latest Fixed dose combination Stories
CORK, Ireland, July 16 /PRNewswire/ --Tibotec Pharmaceuticals today announced that it has entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a new once-daily fixed-dose antiretroviral product containing Tibotec's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride 25 mg) and Gilead's Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) for...
PITTSBURGH, March 30 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL) today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg. Mylan Vice Chairman...
A CCR5 Antagonist That is Dosed Once Daily Could Earn an 18 Percent Patient Share in the U.S. and a 30 Percent Patient Share in Europe, According to a New Report from Decision Resources WALTHAM, Mass., March 11 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed infectious disease specialists identify a therapy's effect on the ability to achieve viral load suppression in treatment-naive...
CHAPEL HILL, N.C., Feb. 5 /PRNewswire/ -- As biopharmaceutical companies focus on line extensions and new product development opportunities, fixed-dose combination (FDC) products have become an increasingly important segment of the market. In an effort to better understand the development strategies and issues for new FDC products, a recent study was conducted by Best Practices, LLC, with insights available in the newly published report, "Product Commercialization Excellence:...
CHAPEL HILL, N.C., Dec. 2 /PRNewswire/ -- New research that delivers a wealth of wide-ranging best practices across major functions such as sales and manufacturing is now available in the Best Practice Database, an online research repository managed by research and consulting firm Best Practices, LLC. To review sample key findings and key topics in these pharmaceutical-focused studies, go to a landing page with links to each of the two new studies at this address:...
Bristol-Myers Squibb Company has announced positive 96-week data from the Castle study, in which 74% of the 440 patients in the Reyataz/r arm achieved an undetectable viral load, defined as HIV-1 RNA less than 50 copies/ml, compared with 68% of the 443 patients in the lopinavir/r arm. The difference between treatment arms may have been related to the 16% discontinuation rate in the Reyataz/r arm and the 21% discontinuation rate in the lopinavir/r arm, the company said. The international,...
Ardea Biosciences has presented positive data from its completed Phase IIa proof-of-concept monotherapy study of RDEA806, the company's investigational non-nucleoside reverse transcriptase inhibitor for patients with human immunodeficiency virus, demonstrating robust antiviral activity with a well-tolerated profile. The Phase IIa randomized, double-blind, placebo-controlled trial evaluated the antiviral activity, pharmacokinetics, safety and tolerability of once- and twice-daily oral dosing...
MEXICO CITY, Aug. 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced that a retrospective analysis of six clinical trials found that anti-HIV regimens containing EPZICOM (abacavir + lamivudine) were effective in treatment-naive patients regardless of baseline viral loads. One of the trials analyzed was a large study comparing treatment with regimens containing EPZICOM versus regimens containing Truvada(R) (tenofovir DF + emtricitabine) in treatment-naive patients with both high and low...
MEXICO CITY, Aug. 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline today announced that 96-week data from the HEAT study show that once-daily EPZICOM (abacavir + lamivudine) provides comparable efficacy to once-daily Truvada(R) (tenofovir DF + emtricitabine) as a first-line option for the treatment of HIV. The data were presented today at the 17th International AIDS Conference in Mexico City, Mexico. HEAT is the first large, prospective, long-term, head-to-head trial to evaluate the safety and...
MEXICO CITY, Aug. 6 /PRNewswire-FirstCall/ -- GlaxoSmithKline (GSK) announced today that a review of data from over 14,600 patients in 54 clinical studies showed no increased risk of myocardial infarction associated with the anti-HIV medication abacavir. GSK conducted this review upon learning that the analysis undertaken by the D:A:D cohort had found an unexpected but potential association between highly active antiretroviral therapy (HAART) regimens containing abacavir and an increased...
