Archive for May, 2008
Schering-Plough is extremely disappointed with the outcome of the National Institute for Health and Clinical Excellence (NICE) appeal panel with regards to the Final Guidance (FAD) around infliximab for the treatment of ankylosing spondylitis (AS).Schering-Plough believes that the economic modelling supporting the Institute’s recommendations was highly unsatisfactory. Indeed, this was the focus of a number of Schering-Plough’s points of appeal.
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ArthroCare Corp. (Nasdaq: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced that a study demonstrating the effectiveness of plasma disc decompression (PDD) for treating patients with contained disc herniation was presented from the podium yesterday at SpineWeek 2008 in Geneva. PDD is a minimally invasive surgical procedure that can be performed under local anesthesia and light sedation.
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NicOx S.A. (Euronext Paris: COX) announced the completion of patient enrollment in the third pivotal phase 3 clinical trial for naproxcinod, in patients with osteoarthritis of the hip (the 303 study). 810 patients have been randomized in 120 clinical centers in North America and Europe in this study, which is the final phase 3 trial in NicOx’ clinical plan for the regulatory filing of naproxcinod.
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Significant numbers of female high school athletes and non athletes suffer from one or more components of the female athlete triad, a combination of three conditions that can lead to cardiovascular disease, according to a new study by Medical College of Wisconsin researchers in Milwaukee.The study results were presented at the American College of Sports Medicine at Indianapolis, by Anne Z. Hoch, D.O.
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Amgen (NASDAQ: AMGN) announced complete results from a head-to-head, double-blind study comparing the effects of twice-yearly subcutaneous injections of denosumab versus weekly oral doses of alendronate (FOSAMAX) on bone mineral density (BMD) in postmenopausal women with low BMD. The results were presented during a late breaking session at this year’s 35th Annual European Symposium on Calcified Tissues (ECTS) meeting. Top-line results of this study were previously reported in January 2008.
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CombinatoRx, Incorporated (NASDAQ: CRXX) announced that it has completed patient enrollment in COMET-1 (CRx-102 Osteoarthritis Multi-center Evaluation Trial), the Company’s Phase 2b clinical trial designed to evaluate the safety and efficacy of CRx-102 in subjects with symptomatic knee osteoarthritis. The COMET-1 clinical study has been overenrolled, with 279 patients participating.
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Osteologix, Inc. (OTCBB: OLGX), a specialty pharmaceutical company, announced today that data from a Phase II clinical study of NB S101 (strontium malonate) was presented at the European Calcified Tissue Society’s 35th Annual Meeting in Barcelona, Spain.
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The escalating obesity epidemic in the United States has focused attention on obesity as a risk factor for coronary artery disease, type 2 diabetes, and hypertension. But being overweight is also a risk factor for osteoarthritis (OA), the degeneration of the cartilage at the ends of bones, which results in painful and restricted movement, said an expert at the 55th Annual Meeting of the American College of Sports Medicine. Stephen P. Messier, Ph.D.
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LDR, a total spine solution company, announced that it has begun to market its ROI-T™ partial vertebral body replacement device following recent 510(k) clearance from the United States Food and Drug Administration. The ROI-T™ is a transforaminal approach implant with an anatomic shape that conforms to the anterior vertebral body, the minimal width and tapered end of the device facilitating insertion through a small opening.
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Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, announced that it has received FDA approval to restart patient enrollment in a pivotal IDE trial of its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. Impliant voluntarily suspended enrollment in the study in September of last year following one device-related failure.
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