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Clinical Intelligence

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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CRF Health eCOA webinar series

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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FDA approves Hetlioz for sleep-wake disorder in blind individuals

Monday, February 3, 2014 10:38 AM

The FDA approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (non-24) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.

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The CenterWatch Monthly, February 2014

Monday, February 3, 2014 08:59 AM

Tracking major changes in the R&D pipeline

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Omeros reports positive results from OMS824 phase IIa clinical trial

Friday, January 31, 2014 01:25 PM

Omeros has announced positive results from a phase IIa clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well-tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.

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Singapore's influenza vaccines shows favorable immunogenicity, tolerability

Friday, January 31, 2014 01:20 PM

Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology have announced that their influenza vaccine (gH1-Qbeta) met its primary end point for immunogenicity (seroconversion based on haemaglutination inhibition titres according to FDA criteria) in the phase I clinical trial in healthy Asian volunteers. The induced immune response showed good cross-reactivity to recent drifted H1N1 strains. The H1N1 influenza vaccine candidate is based on Cytos' proprietary bacteriophage Qbeta virus-like particle (VLP) technology.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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