Biocompare.com RSS feed http://www.biocompare.com/ © 2010 Biocompare.com Sun, 01 Aug 2010 02:14:17 GMT http://backend.userland.com/rss RSS.NET: http://www.rssdotnet.com/ DURHAM, N.C. - Practitioners of clinical medicine are familiar with learning curves, and strategies like simulation are increasingly used to minimize learning-curve effects on clinical care. Because similar learning curves have been hinted at in some clinical trials, researchers at Duke University Medical Center studied the phenomenon in the data record of a large, multi-site clinical trial. Their findings point to ways to improve the quality of future trials through better training and simulation exercises. http://news.biocompare.com/newsstory.asp?id=335982 Biocompare.com Fri, 30 Jul 2010 14:18:00 GMT ArQule, Inc. (Nasdaq: ARQL) today announced the initiation of a Phase 2, single agent trial with ARQ 197 in gastric cancer by Kyowa Hakko Kirin, its exclusive licensee for the development and commercialization of ARQ 197 in the Asian territory consisting of Japan, China (including Hong Kong), South Korea and Taiwan. Initiation of this trial will trigger a $5 million milestone payment to ArQule from Kyowa Hakko Kirin. http://news.biocompare.com/newsstory.asp?id=335945 Biocompare.com Fri, 30 Jul 2010 10:54:00 GMT Orexigen® Therapeutics, Inc. announced that results from its COR-I trial of Contrave® were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug Administration. Results show that patients taking Contrave were two to three times more likely to lose at least 5% or 10% of their body weight compared to those taking placebo, on both an intent-to-treat (ITT) and completers basis. http://news.biocompare.com/newsstory.asp?id=335934 Biocompare.com Fri, 30 Jul 2010 04:08:00 GMT Anthera Pharmaceuticals, Inc. , a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced it has initiated PEARL-SC, the Phase 2b study of A-623, a novel inhibitor of B-Cell Activating Factor, or BAFF, for the treatment of Systemic Lupus Erythematosus (lupus). Lupus patients suffer from a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain, major organ complications, and cardiovascular disease. http://news.biocompare.com/newsstory.asp?id=335844 Biocompare.com Fri, 30 Jul 2010 04:07:00 GMT Intra-Cellular Therapies, Inc. today announced the results from a Phase Ib/II clinical trial in patients with schizophrenia with ITI-007, the Company's unique, investigational new drug for the treatment of schizophrenia. The trial met its primary endpoint demonstrating that ITI-007 was safe and well-tolerated in patients with stabilized schizophrenia. In addition, several exploratory endpoints were evaluated. Treatment with ITI-007 yielded important clinical signs consistent with antipsychotic and antidepressant efficacy including a reduction in the total Positive and Negative Syndrome Scale (PANSS) and the Calgary Depression Scale for Schizophrenia (CDSS). These results establish a firm basis for selecting an active dose range for future efficacy trials of ITI-007 in the treatment of patients with acutely exacerbated schizophrenia. http://news.biocompare.com/newsstory.asp?id=335850 Biocompare.com Fri, 30 Jul 2010 04:07:00 GMT Bionovo, Inc. announced today that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba. http://news.biocompare.com/newsstory.asp?id=335786 Biocompare.com Fri, 30 Jul 2010 04:06:00 GMT Bionovo, Inc. (Nasdaq: BNVI) announced today that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European marketing authorization for Menerba. http://news.biocompare.com/newsstory.asp?id=335783 Biocompare.com Thu, 29 Jul 2010 16:49:00 GMT Dendreon Corporation (Nasdaq: DNDN) announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE(R) (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC). The manuscript is published in the July 29, 2010 issue of the journal. http://news.biocompare.com/newsstory.asp?id=335739 Biocompare.com Thu, 29 Jul 2010 08:11:00 GMT Angiotech Pharmaceuticals, Inc. ("Angiotech") and partner Athersys, Inc. announced positive results from its phase I clinical trial of MultiStem®, its allogeneic cell therapy product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. The study results, which represent at least four months of post-treatment patient data, demonstrate that MultiStem was well tolerated at all dose levels and also suggest improvement in heart function in treated patients. http://news.biocompare.com/newsstory.asp?id=335712 Biocompare.com Thu, 29 Jul 2010 05:34:00 GMT Dendreon Corporation announced today the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE® (sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC). The manuscript is published in the July 29, 2010 issue of the journal. http://news.biocompare.com/newsstory.asp?id=335721 Biocompare.com Thu, 29 Jul 2010 05:34:00 GMT