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Ikaria initiates enrollment in LUCASSIN Phase III trial for HRS Type 1

Ikaria, Inc. announced that it has enrolled the first patients in its pivotal Phase III trial for LUCASSIN® (terlipressin). The multi-center, randomized, placebo-controlled, double-blind trial is known as the REVERSE Trial.

30 Nov 2010

FTC/TDF tablet reduces HIV infection among high-risk individuals: iPrEx study

In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill. New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.

24 Nov 2010

iPrEx study: PrEP reduces HIV infection risk among gay, bisexual men

A daily dose of an oral antiretroviral drug, currently approved to treat HIV infection, reduced the risk of acquiring HIV infection by 43.8 percent among men who have sex with men.

24 Nov 2010

Gilead submits Truvada/TMC278 single-tablet regimen NDA to FDA

Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the single-tablet regimen of Truvada® (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults. If approved, this would be the second product that contains a complete HIV treatment regimen in a single once-daily tablet.

23 Nov 2010

Interim results from H.P. Acthar Gel study in patients with advanced diabetic nephropathy

On November 20 at the American Society of Nephrology 43rd Annual Meeting, interim results presented from an ongoing, randomized prospective study conducted independently by James A. Tumlin, MD, at the University of Tennessee College of Medicine Chattanooga indicated that 9 of 15 patients (60%) with advanced diabetic nephropathy who are currently enrolled in the study and have completed or are still undergoing a six month course of treatment with H.P. Acthar ® Gel have exhibited a clinically significant decrease in proteinuria and achieved stabilized renal function.

22 Nov 2010

VYTORIN reduces major vascular events in patients with chronic kidney disease

In a new investigational study of VYTORIN, the cholesterol-lowering medicine from Merck, VYTORIN 10/20 mg reduced the incidence of first major vascular events defined as non-fatal heart attacks or cardiac death, stroke or any revascularization procedure by a highly statistically significant 16.1 percent compared to placebo, Study of Heart and Renal Protection study involved more than 9,000 patients who, on average, had advanced or end-stage chronic kidney disease (CKD)

22 Nov 2010

Racial and socioeconomic disparities exist in kidney transplantation

Research shows that people with low incomes are more likely to develop kidney failure and less likely to receive a living donor kidney transplant than people of other socioeconomic classes.

22 Nov 2010

Presence of albumin in urine predicts cognitive decline: Study

A new study has found that low amounts of albumin in the urine, at levels not traditionally considered clinically significant, strongly predict faster cognitive decline in older women.

21 Nov 2010

Pfizer's Phase 3 AXIS 1032 trial for metastatic renal cell carcinoma meets primary endpoint

Pfizer Inc. announced today that the Phase 3 AXIS 1032 trial (A4061032), studying the investigational compound axitinib in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival when compared to sorafenib, in the study population.

20 Nov 2010

Merck wins third FOSAMAX bellwether trial

Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.

20 Nov 2010

Aeterna presents data on AEZS-108 Phase 2 study for endometrial cancer at EORTC-NCI-AACR Symposium

Aeterna Zentaris Inc., earlier today, presented Phase 2 positive efficacy and safety data for its compound, AEZS-108, in advanced endometrial cancer.

18 Nov 2010

Scios announces results of ASCEND-HF trial for ADHF treatment

Scios Inc. announced today that the landmark investigational study of NATRECOR (nesiritide) for the treatment of acutely decompensated heart failure (ADHF), ASCEND-HF, demonstrated no statistically significant difference from placebo in the co-primary endpoints of dyspnea, measured at six and 24 hours, or in the composite of heart failure re-hospitalizations and death during the first 30 days following treatment.

15 Nov 2010

Nile third quarter net loss decreases to $1.8 million

Nile Therapeutics, Inc., a company focused on the development of novel therapeutics for therapeutics for cardiovascular disease, today announced its third quarter financial results for 2010.

12 Nov 2010

Colcrys safe for treating gout flares

Patients who experience gout flares can be treated safely with Colcrys (colchicine, USP), even in the presence of co-morbid conditions that often present physicians with treatment challenges, according to a new analysis presented here at the 74th Annual Scientific Meeting of the American College of Rheumatology (ACR).

9 Nov 2010

Positive results from Ardea's RDEA594 combination study with febuxostat or allopurinol for gout

Ardea Biosciences, Inc. announced positive results from two clinical studies of RDEA594 in combination with currently marketed drugs for the treatment of gout patients, febuxostat (Uloric®) and allopurinol.

8 Nov 2010

Nile announces results of CD-NP Phase 2 study in renally compromised ADHF patients

Nile Therapeutics, Inc. a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced results of its Phase 2 study evaluating its lead compound CD-NP in patients with acute decompensated heart failure (ADHF) and mild to moderate renal insufficiency. Study results demonstrated that multiple doses were characterized as well tolerated with favorable drug activity in this acute patient population.

3 Nov 2010

Gilead to present data of two Phase III trials evaluating Viread efficacy for HBV infection at The Liver Meeting 2010

Gilead Sciences, Inc. today announced new data from the open-label phase of two pivotal Phase III clinical trials (Studies 102 and 103) evaluating the four-year efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection.

1 Nov 2010

High erythropoietin levels predict higher mortality

High erythropoietin levels in people over age 85 indicate a higher risk of death, according to a study published in CMAJ.

26 Oct 2010

Biomarkers can improve ability to identify patients at high risk of CKD: Study

Measuring three biomarkers in a single blood sample may improve physicians' ability to identify patients at high risk of developing chronic kidney disease, according to a study appearing in an upcoming issue of the Journal of the American Society of Nephrology.

22 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010