Clinical Intelligence

NPS Pharmaceuticals' phase III REPLACE study shows positive results

Monday, November 7, 2011 01:06 PM

NPS Pharmaceuticals has reported positive top-line results from REPLACE, a phase III registration study of NPSP558, the company's bioengineered replica of human parathyroid hormone (rhPTH 1-84), in adult hypoparathyroidism patients. NPS has received orphan drug status for NPSP558 for the treatment of hypoparathyroidism, a rare endocrine disorder in which the body produces insufficient levels of parathyroid hormone, the principal regulator of calcium and phosphorus, and for which there is no FDA-approved replacement therapy. The symptoms of hypoparathyroidism are typically managed with large doses of oral calcium supplementation and active vitamin D therapy to reduce the severity of symptoms. The prolonged use of oral calcium supplementation and active vitamin D therapy may result in serious long-term health complications.

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FDA approves XARELTOR

Monday, November 7, 2011 09:34 AM

The FDA has approved XARELTOR to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. XARELTOR is the only oral anticoagulant approved in the U.S. that offers once-daily dosing, without
the need for routine blood monitoring.

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Jennerex enrolls first patient in phase IIb liver cancer trial

Friday, November 4, 2011 11:33 AM

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Senesco initiates dosing in SNS01-T study

Thursday, November 3, 2011 10:12 AM

Senesco Technologies has initiated dosing in its phase Ib/IIa clinical study of SNS01-T at the Mayo Clinic in Rochester, MN. The study is an open-label, multiple-dose, dose-escalation study which will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to relapsed or refractory multiple myeloma patients.

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Thoratec enrolls first patient in two year ROADMAP study

Thursday, November 3, 2011 09:21 AM

Thoratec has enrolled the first patient into the ROADMAP (risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients) study. The patient was enrolled at INTEGRIS Baptist Medical Center in Oklahoma City.

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Resverlogix begins dosing in phase IIb ASSURE trial

Wednesday, November 2, 2011 11:43 AM

Resverlogix has initiated dosing in ASSURE, a phase IIb clinical trial led by the Cleveland Clinic. ASSURE is a 26-week, multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial that will assess coronary atherosclerotic plaque changes in response to Resverlogix's lead drug RVX-208 using intravascular ultrasound (IVUS).  ASSURE will examine the early effects of RVX-208 induced ApoA-I production on atherosclerotic plaque regression in the setting of patients with coronary artery disease who have a low level of high-density lipoprotein cholesterol (HDL-C).  A total of 310 patients are expected to participate in ASSURE of which 77 will receive placebo and 233 will be given 100 mg twice daily of RVX-208.

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The CenterWatch Monthly, November 2011

Tuesday, November 1, 2011 02:05 PM

CRAs see role evolving into quality, compliance, start-up

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FDA approves Roche’s hepatitis B test

Monday, October 31, 2011 12:51 PM

Roche has reported that the FDA granted Premarket Approval (PMA) for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module of the cobas 6000 analyzer series for mid-volume laboratories. The test represents the final component of the acute panel within the hepatitis test menu for the cobas 6000 series.

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Revalesio’s first human asthma trial shows promising results

Monday, October 31, 2011 11:39 AM

Revalesio has reported that in this first in man asthma study, RNS60 demonstrated therapeutic benefit and proved safe at all dose levels. In a multi-dose stage of the phase I study, RNS60 significantly improved peak flows and quality of life scores in patients diagnosed with stable, mild to moderate asthma. These findings demonstrate that RNS60, a novel product containing charge-stabilized nanostructures (CSN), is safe and has therapeutic benefit in human subjects suffering from asthma.

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Gilead submits NDA for HIV regimen

Friday, October 28, 2011 01:43 PM

Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for marketing approval of the "Quad", a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor.

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