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Comp. Effectiveness Promises Better, Cheaper Health Care But Critics Link It To Rationing
"Federal health agencies, seeking to hand out stimulus funds to research the effectiveness of various medical treatments, said they will include projects that look in part at the cost of drugs and other treatments. The approach -- which was unveiled in a report to Congress this week by the Agency for Healthcare Research and Quality and the National Institutes of Health, both agencies under the Department of Health and Human Services -- could provide more fodder to conservatives worried that the government might use the results of such studies to limit health care to consumers," the Wall Street Journal reports.
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FDA Approves VYVANSE CII Label Change To Include Supplementary Clinical Data Supporting Efficacy At 13 Hours Postdose In Children Age 6-12 With ADHD
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved a change to the prescribing information for its once-daily Attention Deficit Hyperactivity Disorder (ADHD) treatment VYVANSE® (lisdexamfetamine dimesylate) CII, to include supplemental data that demonstrated significant ADHD symptom control in children aged 6 to 12 from the first time point measured (1.5 hours) through 13 hours postdose. VYVANSE is now the first and only oral ADHD stimulant treatment to have 13-hour postdose efficacy data for pediatric patients included in its product labeling.
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Promedior Initiates Phase 1 Clinical Trial Of PRM-151, A Novel Compound For The Treatment Of Fibrotic Diseases And Tissue Remodeling

Promedior, Inc. announced the initiation of a Phase 1 clinical trial of PRM-151, a novel compound in development for the treatment of fibrotic diseases and tissue remodeling. The Phase 1 dose escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of ascending single intravenous doses of PRM-151 in healthy subjects. The study is being conducted at the Centre for Human Drug Research in The Netherlands. PRM-151(rhSAP) is a recombinant form of human Serum Amyloid P, a highly conserved natural human protein that mediates its anti-fibrotic activity by targeting the specific cell populations that orchestrate fibrosis and tissue remodeling. PRM-151 has demonstrated an outstanding preclinical safety profile and robust preclinical efficacy by reducing fibrosis in multiple tissues, organs, and disease models. "The initiation of the Phase 1 clinical trial of PRM-151 represents an important milestone in the development of Promedior"s novel platform of products for the treatment of fibrotic diseases," said Dominick Colangelo, Chief Executive Officer of Promedior. "We believe that PRM-151 has tremendous potential to play an important role in improving patient outcomes across multiple disease indications and will position Promedior in a leadership position in the development of innovative anti-fibrotic therapeutics." "Through its fundamental role in regulating monocyte responses to injured tissue, we believe PRM-151 affects a common biology present in all forms of pathologic fibrosis," commented Dr. Mark Lupher, Jr., the company"s Senior Vice President of Discovery Research. "In collaboration with leading investigators at Harvard University, Yale University, University of Michigan, University of California San Diego and Rice University, we have consistently demonstrated significant anti-fibrotic activity across model systems, including in established disease settings, and are very excited to advance this novel compound into clinical research." Promedior, Inc.


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