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Janssen expands global cardiovascular research program with three new studies

Monday, March 31, 2014 12:56 PM

Janssen R&D is adding three new clinical trials to its EXPLORER global cardiovascular research program for XARELTO (rivaroxaban), a broadly indicated oral Factor Xa inhibitor. The additional trials will evaluate rivaroxaban for the treatment or prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in pediatric and other patient populations, including those at risk for DVT or PE due to a concurrent medical illness. The new studies will include more than 11,000 patients in over 30 countries.

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CRF Health eCOA webinar series

FDA approves Topamax for migraine prevention in adolescents

Monday, March 31, 2014 12:55 PM

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a dailybasis to reduce the frequency of migraine headaches.

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Report: Strategic partnerships most effective biopharmaceutical outsourcing model

Monday, March 31, 2014 09:07 AM

Global CRO Parexel International has released Strategic Partnerships 2014: Driving Biopharmaceutical Outsourcing Effectiveness at the 23rd Annual Partnerships in Clinical Trials Conference in Las Vegas. It provides insights that highlight the value of these multi-year, highly integrated engagements between sponsors and CROs.

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The Pulse on Technology By Ashley Tointon

Monday, March 31, 2014 09:00 AM

The development of apps for healthcare has reached an all-time high, with thousands currently available for multiple devices for both consumers and healthcare professionals. Global statistics show that downloads of mobile health (mHealth) apps almost doubled in less than a year, from 127 million in 2011 to 247 million by October 2012. With so many different apps available, reviewing all of the options and finding the right one can be daunting. As you sift through the vast array of apps, narrow your choice by assessing functionality, accessibility and cost.

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Praziquantel Consortium aims to fight schistosomiasis in pre-schoolers

Friday, March 28, 2014 03:18 PM

Brazilian Farmanguinhos, part of Fiocruz, and U.K.-based Simcyp are reinforcing the international nonprofit Pediatric Praziquantel Consortium. The aim of the consortium is to develop and register a new pediatric formulation against schistosomiasis for preschool-age children, a group currently lacking a suitable treatment. 

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Report: Nearly 40 new medicines in development for Parkinson’s disease

Friday, March 28, 2014 03:17 PM

America’s biopharmaceutical research companies currently are developing 37 innovative new medicines to help the estimated 10 million people worldwide living with Parkinson’s disease. These medicines in development, all either in clinical trials or under review by the FDA, include 23 for Parkinson’s disease, 11 for related conditions and three diagnostics, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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NICE seeks views on how it assesses drugs and other technologies for the NHS

Friday, March 28, 2014 03:15 PM

The National Institute for Health and Care Excellence (NICE) has begun a formal consultation on proposed changes to the way it makes recommendations on new medicines and other treatments for use in the NHS. NICE assesses the clinical and cost effectiveness of new technologies to help ensure patients have access to effective treatments and the NHS makes the best use of its resources.

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Exco InTouch launches Exco Valued Partner Network

Friday, March 28, 2014 03:14 PM

Exco InTouch, a provider of patient engagement and data capture solutions for clinical research and healthcare providers, will launch the Exco Valued Partner Network.  

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National MS Society invests $29M in 83 research projects

Friday, March 28, 2014 03:13 PM

The National Multiple Sclerosis Society has committed $29 million to support an expected 83 new MS research projects and training awards. These are part of a comprehensive research strategy aimed at stopping MS, restoring function that has been lost and ending the disease forever.

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SIGNiX, SAFE-BioPharma form digital signature partnership

Friday, March 28, 2014 03:12 PM

SIGNiX, a digital signature vendor, will partner with SAFE-BioPharma Association to provide a self-contained digital signature service compliant with the global SAFE-BioPharma signature standard. The service will allow healthcare and other regulated organizations to quickly and easily start a complete cloud-based digital signature product. SAFE-BioPharma is the nonprofit industry coalition responsible for the ongoing development and implementation of the global SAFE-BioPharma digital identity and signature standard.

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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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The CenterWatch Monthly

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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