Clinical Intelligence

Sinovac's EV71 vaccine produces positive phase III clinical trial results

Friday, February 28, 2014 11:35 AM

Sinovac Biotech, a provider of biopharmaceutical products in China, has announced that Phase III clinical trial results for its proprietary Enterovirus 71 (EV71) vaccine have been published online in the February 27 issue of TheNew England Journal of Medicine (NEJM). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease (HFMD), or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac's vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.

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WIRB Copernicus Group

FDA approves Myalept to treat rare metabolic disease

Wednesday, February 26, 2014 11:42 AM

The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. 

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Berg, the Parkinson's Institute partner for clinical development

Friday, February 21, 2014 02:08 PM

Berg and the Parkinson's Institute and Clinical Center have announced the next phase in their ongoing partnership, focused on identifying potential biomarkers that may lead to breakthroughs in the research, diagnosis, and treatment of Parkinson's disease. Using Berg's Interrogative Biology platform to analyze multi-omic tissue samples (skin fibroblasts, blood, urine) supplied by the Parkinson's Institute, this collaboration will identify the differences between healthy and diseased tissues in an effort to unravel the mysteries of Parkinson's disease. Berg and the Parkinson's Institute together are the first teams to approach biomarker discovery by looking at proteomics, metabolomics, and lipidomics, in addition to clinical data, simultaneously in human patients and controls from the same cohort.   

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FDA approves Northera to treat neurogenic orthostatic hypotension

Wednesday, February 19, 2014 03:53 PM

The FDA has approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy and pure autonomic failure.  

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CardioCell launches two new acute myocardial infarction trials

Wednesday, February 19, 2014 03:11 PM

CardioCell, a global biotechnology company that explores therapeutic applications of unique, patented, ischemia-tolerant mesenchymal stem cells (itMSCs) manufactured under cGMP conditions, announces two new clinical trials using its allogeneic stem-cell therapy to treat subjects with acute myocardial infarction (AMI), a problem facing more than 1.26 million Americans annually. In the U.S., CardioCell is initiating a phase IIa AMI clinical trial to evaluate the clinical safety and efficacy of its itMSCs. In addition, the Ministry of Health in Kazakhstan is beginning a phase III AMI clinical trial on the intravenous administration of CardioCell’s itMSCs, based on the efficacy and safety found in phase II clinical trials.

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Generex releases positive interim phase II breast cancer vaccine trial results

Friday, February 14, 2014 01:15 PM

Generex Biotechnology has announced that recent results from a phase II study of a novel cancer vaccine designed to prevent relapse in patients who have had breast cancer corroborate prior results from an interim analysis conducted in October of 2011.

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Pronutria launches two clinical trials

Friday, February 14, 2014 01:03 PM

Pronutria, a company a discovery engine and pipeline of pharmaconutrient products, has announced the beginning of two clinical trials evaluating its lead ProNutrein product candidates. The company is utilizing its ProNutrein discovery platform to identify and develop protein pharmaconutrients, protein nutrients identified in food with beneficial impact in many areas of human health, including muscle, metabolic and gastrointestinal health. Pronutria also announced the closing of a $12.25 million financing that will fund the advancement of the ProNutrein pipeline as well as the development of additional candidates as medical foods and supplements, and in a separate business unit, as therapeutics.

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FDA approves Imbruvica to treat chronic lymphocytic leukemia

Wednesday, February 12, 2014 02:30 PM

The FDA has expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.

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Aerie Pharmaceuticals initiates phase IIb study of PG324

Monday, February 3, 2014 11:16 AM

Aerie Pharmaceuticals, a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, has dosed the first patients enrolled in the company's phase IIb study of PG324, a novel, fixed-combination of Aerie's AR-13324 and latanoprost, a prostaglandin analogue that is the most widely prescribed glaucoma drug. The 28-day, phase IIb clinical trial is expected to enroll approximately 300 patients with glaucoma or ocular hypertension and will compare two concentrations of PG324 to latanoprost and to AR-13324, all dosed once daily. The efficacy endpoint will be superiority of PG324 to each of its components, as measured by the lowering of mean diurnal intraocular pressure (IOP) on day 28 compared to baseline. Topline results of this trial currently are expected in mid-2014.

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Avanir Pharmaceuticals submits NDA for AVP-825

Monday, February 3, 2014 11:01 AM

Avanir Pharmaceuticals, a biopharmaceutical company focused on central nervous system disorders of high unmet medical need, has submitted a NDA to the FDA for approval of AVP-825, its innovative Breath Powered investigational drug-device combination product for the acute treatment of migraine.

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