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Wednesday, 10 March 2010
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The Company's supplemental New Drug Application (sNDA) for once-daily XiDay (bromfenac ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has granted XiDay a standard review time of ten months, assigning ISTA a Prescription Drug User Fee Act (PDUFA) action date of October 16, 2010. ISTA's request for a shorter, six-month priority review is still under consideration by the FDA. Xibrom is an eye drop formulation of a non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Link: http://phx.corporate-ir.net/phoenix.zhtml?c=121179&p=irol-newsArticle&ID=1400153&highlight= Source:ISTA |
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Wednesday, 10 March 2010
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The successful completion of the Phase III efficacy clinical trial for the fentanyl sublingual spray product candidate was announced. The product is being developed for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant cancer patients and the Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study. Dose levels of 100 – 1600 mcg were tested in the trial. Link: http://www.insysrx.com/news.htmSource:INSYS |
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Wednesday, 10 March 2010
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A new questionnaire and outcomes measurement scale, the Clinically Useful Anxiety Outcome Scale (CUXOS) developed by the department of psychiatry at Rhode Island Hospital has proven to be a reliable and valid measure of anxiety. The scale can easily be incorporated into routine clinical practice when treating psychiatric disorders. The study appears online ahead of print in the Journal of Clinical Psychiatry. Link: http://www.eurekalert.org/pub_releases/2010-03/l-rdn030910.phpSource:EurekAlert |
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Wednesday, 10 March 2010
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In studying the insulin resistance of 29 people with Hepatitis C, Australian researchers have confirmed that they have high insulin resistance, a precursor to diabetes. However, almost all insulin resistance was in muscle, with little or none in the liver, a very surprising finding given that Hepatitis C is a liver disease. The study has been published in the prestigious international journal, Gastroenterology, now online. Link: http://www.eurekalert.org/pub_releases/2010-03/ra-sfa030910.phpSource:EurekAlert |
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Wednesday, 10 March 2010
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The publication of positive results from a large international study which demonstrated that the Oncotype DX(R) breast cancer Recurrence Score(R) (RS) result is a significant independent predictor of distant recurrence in both node-negative and node-positive, hormone receptor-positive, postmenopausal breast cancer patients who are treated with either anastrozole or tamoxifen was announced. The study, originally presented at the San Antonio Breast Cancer Symposium in 2008, was published online today in the Journal of Clinical Oncology. Link: http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=450267Source:Genomic Health |
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Wednesday, 10 March 2010
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The U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of Esbriet (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function. Preclinical and in-vitro evidence has shown that Esbriet has both anti-fibrotic and anti-inflammatory effects. Link: http://phx.corporate-ir.net/phoenix.zhtml?c=100067&p=irol-newsArticle&ID=1400827&highlight= Source:InterMune |
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Wednesday, 10 March 2010
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Genital herpes, a condition that produces painful sores and increases transmission of AIDS, has infected one in six Americans, according to a U.S. study that shows prevention efforts haven’t stopped outbreaks. The study was released today by the U.S. Centers for Disease Control and Prevention in Atlanta. Link: http://www.bloomberg.com/apps/news?pid=20601124&sid=abG4kKKZUMrsSource:Bloomberg |
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Wednesday, 10 March 2010
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Obese patients with colon cancer are at greater risk for death or recurrent disease compared to those who are within a normal weight range, according to a report in Clinical Cancer Research, a journal of the American Association for Cancer Research. Link: http://www.eurekalert.org/pub_releases/2010-03/aafc-olt030210.phpSource:EurekAlert |
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