Winston Laboratories, Inc. Receives Notice Of Non-Compliance In Canada For Its New Drug Submission Of CIVANEX To Treat Osteoarthritis
Winston Laboratories, Inc. ("Winston Labs"), a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. (OTC BB: WPHM) today announced that it has received a Notice of Non-compliance ("NON") from the Therapeutics Drug Directorate, Health Canada (the "Directorate") for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis. The Directorate remarked that the analysis of the pivotal trial did not support the requested indication. Winston Labs has a period of ninety days to submit a response to the Directorate's NON, which it intends to do. "Winston Labs intends to fully address the comments in the NON, and believes that the clearly favorable risk-benefit profile of CIVANEX should lead to approval in Canada, " stated Joel E.
Updated Data From Randomized Controlled Phase II Study Evaluating Oral Apremilast In Psoriatic Arthritis Demonstrates Sustained Response At Six Months
Celgene Corporation (NASDAQ: CELG) announced that updated results of a phase II, multi-center, randomized, double-blind, placebo-controlled, three-arm study of apremilast in adult patients with psoriatic arthritis (CC-10004-PSA-001) were presented today at the American College of Rheumatology (ACR) 2009 annual meeting in Philadelphia, PA. Apremilast is an oral pluripotent immunomodulator that inhibits the activity of PDE4 and modulates the production of multiple pro-inflammatory mediators, including TNF-Î, IL-2 IL-10, IL-17, and IL-23. CC-10004-PSA-001 sought to determine the efficacy and safety of apremilast in 204 patients at two different dosing regimens - 20mg twice per day (BID) or 40mg once per day (QD) compared to placebo after 12 weeks, with 126 patients participating in an extension of the study for an additional 12 weeks (24 weeks total).
An important assay used to aid in the diagnosis of rheumatoid arthritis (RA) will soon be available on Abbott's ARCHITECT immunoassay analyzers. The FDA has granted 510(k) clearance for an antibody cyclic-citrulinated peptide, or anti-CCP assay, to run on the world class systems. Many patients with RA develop an immune response against proteins containing citrulline long before they present symptoms of the disease. Studies show detecting the level of these antibodies earlier in the disease continuum, in conjunction with other clinical information, is critical to the early diagnosis of the disease. The American College of Rheumatology treatment guidelines for RA recommends early diagnosis of the disease and timely introduction of therapies to prevent potentially irreversible joint damage.
A comprehensive account of the most important advances in rheumatology research from the past decade has been published in BioMed Central's open access journal Arthritis Research and Therapy (AR&T). This freely available collection of 38 articles written by an internationally recognized group of experts spanning more than 400 pages is an essential educational tool which provides clinicians and researchers with a detailed overview of the current status of basic, translational and clinical research in rheumatology. Rheumatic diseases affect the body's joints, muscles, skin and a variety of internal organs and connective tissues. Current estimates indicate that some 43 million Americans have been diagnosed to date as well as even greater numbers worldwide.
Damaged knee joints might one day be repaired with cartilage grown from stem cells in a laboratory, based on research by Professor Kyriacos Athanasiou, chair of the UC Davis Department of Biomedical Engineering and his colleagues. Using adult stem cells from bone marrow and skin as well as human embryonic stem cells, Athanasiou and his group have already grown cartilage tissue in the lab. Now they are experimenting with various chemical and mechanical stimuli to improve its properties. Cartilage is one of the very rare tissues that lacks the ability to heal itself. When damaged by injury or osteoarthritis, the effects can be long-lasting and devastating.
PHILADELPHIA - Investigators are reporting that tolicizumab is an effective, long-term treatment option in multiple subgroups of rheumatoid arthritis (RA) patients. These include patients who have an inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR), patients who have an inadequate response to anti-TNF inhibitors (TNF-IR), and patients who have not failed methotrexate. The new results were announced at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting. Joseph S. Smolen, MD, chairman of the rheumatology department at the Medical University of Vienna in Vienna, Austria, and colleagues presented 3.