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Covance expands global biologics capabilities

Monday, March 31, 2014 01:36 PM

Covance is expanding its global bioanalytical footprint and adding scientific leaders to its biologics team. It is expanding its large-molecule bioanalytical space co-located with its central laboratory facility in Indianapolis.

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CRF Health eCOA webinar series

North Shore InnoVentures receives $1.65M from Massachusetts Life Sciences Center

Monday, March 31, 2014 01:29 PM

North Shore InnoVentures (NSIV), a New England technology incubator and business accelerator, has received a capital grant of $1.65 million from the Massachusetts Life Sciences Center (MLSC). The grant will allow NSIV to expand its current laboratory facilities over the next three years and purchase advanced analytical instrumentation. This grant is part of a larger $5 million award to the Life Sciences Consortium of the North Shore (LSCNS), consisting of Endicott College, Gordon College, North Shore InnoVentures, North Shore Community College and Salem State University, that will fund major lab/facility and equipment upgrade projects at the member institutions and organizations.

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FDA approves long-acting recombinant coagulation Factor IX concentrate for hemophilia B

Monday, March 31, 2014 01:10 PM

The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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Kite Pharma granted FDA Orphan Drug Designation for Anti-CD19

Monday, March 31, 2014 01:06 PM

Kite Pharma, a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, has announced that the FDA Office of Orphan Products Development (OOPD) granted Orphan Drug Designation for the company's lead investigational therapy, an autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL).

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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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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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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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