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FDA Classifies Previously Announced Medtronic Physician Advisory On Small Subset Of Kappa And Sigma Pacemakers As Class I Recall
Medtronic, Inc. (NYSE: MDT) announced the U.S. Food and Drug Administration (FDA) has classified Medtronic"s previously announced physician advisory about a small subset of Kappa® and Sigma® series pacemakers, identified at increased susceptibility for separation of bonded interconnect wires from the electronic circuit, as a Class I recall. Notification to U.S. FDA, physicians and patients began May 18, 2009. As of the date of this news release, more than 95 percent of physicians following affected devices in the United States have confirmed receipt of the notification. The FDA"s classification of Medtronic"s Important Patient Safety Information does not alter the patient management recommendations already provided in the May 2009 letter, and physicians need not take any new action.
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'Outstanding' Primary-Care Researcher Receives Prestigious Award
The "outstanding" work of Julia Hippisley-Cox, Professor of Clinical Epidemiology and General Practice at The University of Nottingham, has been recognised by the Royal College of General Practitioners.
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Xcelience Reduces Time To Phase I Studies By 17 Weeks Using API Into Capsule Services
Xcelience, a leader in early drug development services, has developed a faster, more cost effective path to Phase I studies using Xcelodose® 600 and 600 S precision powder micro-dosing systems (Xcelodose® is a registered trademark of Capsugel® BVBA). API into Capsule projects are on average completed 45 percent faster than traditional formulation efforts, and in some specific cases we have saved our clients as much as 17 weeks.
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Phase III Data Showed Novartis Investigational Bronchodilator QAB149 Significantly Improved Lung Function In COPD Patients

The Novartis investigational bronchodilator QAB149 (indacaterol) met the primary efficacy endpoints of improved lung function compared to placebo at 12 weeks in three pivotal phase III studies in chronic obstructive pulmonary disease (COPD) patients. In secondary endpoints of these studies, QAB149 demonstrated clinically relevant lung function improvements within five minutes of the first dose, lasting for 24 hours in COPD patients. The QAB149 data, which were presented at the American Thoracic Society (ATS) 2009 International Conference in San Diego, are the first from the Phase III INVOLVE, INHANCE and INLIGHT-1 trials. These were three multinational, multi-center, randomized, double-blind, placebo-controlled studies in over 3,800 patients with moderate-to-severe COPD. "Current management of COPD focuses on the use of bronchodilators to optimize lung function," said Professor Stephen I. Rennard, Pulmonary and Critical Care Medicine, University of Nebraska Medical Center. "As presented at the ATS meeting, QAB149 is a long-acting beta-agonist bronchodilator given once daily that significantly improved both airflow and clinical outcomes. The ability to provide bronchodilation on a once-daily basis will be an important addition to the current therapeutic armamentarium in COPD." In the six-month INHANCE trial, QAB149 150÷µg and 300÷µg doses significantly improved lung function at 12 weeks compared to placebo. Improvements [measured by difference in trough forced expiratory volume in one second (FEV1 )] were observed after one day (110mL and 140mL), at the 12 week primary endpoint (both doses 180mL), and at 26 weeks (160mL and 180mL). Results were statistically significant (p Novartis Pharmaceuticals Corporation


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