• Apotex Sues Health Canada Over an ‘Unlawful’ Ban on its Drugs

    Nov 21, 2014, 00:00 by Michael Croft
    WSJ | Apotex, which is one of the larger generic drug makers in Canada, is lashing out at regulators, alleging in a lawsuit that a recent ban on drugs from its Indian plants was illegal and politically motivated.
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  • New Rules for Clinical Trial Results Disclosure

    Nov 20, 2014, 13:00 by Michael Croft
    Nature News | Regulations proposed yesterday would increase clinical trial transparency.
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  • PHT Releases Electronic Neuropsychiatric Interview, Rater Training

    Nov 19, 2014, 10:00 by Michael Croft
    Clinical Informatics News | PHT has released an electronic version of the Mini International Neuropsychiatric Interview (M.I.N.I.) for electronic data capture, and has developed training for the tool that will improve data quality and optimize the uniformity of clinician-reported data capture across clinical studies.
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  • $2.6 Billion Drugs, Or Not

    Nov 18, 2014, 14:00 by Michael Croft
    Clinical Informatics News | The Tufts Center for the Study of Drug Development released new estimates today of how much it costs to develop and win marketing approval for a drug. The total? $2.6 billion.
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  • Clinverse, Inc. Names Seasoned Industry Veteran as Chief Commercial Officer

    Nov 18, 2014, 00:00 by Michael Croft
    DURHAM, NC - Nov 18, 2014 - Clinverse, Inc., provider of automated financial management technology solutions for clinical trials, announced today the addition of John Musante as Chief Commercial Officer
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  • Definiens Predicts Biggest Drivers for Personalized Medicine in 2015: Data Quality, Immunotherapy, Combination Treatments and Predictive Biomarkers

    Nov 18, 2014, 00:00 by Michael Croft
    MUNICH, GERMANY - Nov 18, 2014 - Major opportunities are on the horizon for personalized medicine and clinical cancer research and treatment, according to Definiens, the global leader in Tissue Phenomics® for oncology diagnostics
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  • Regeneron Drug Lowers LDL for Patients Who Cant Take Statins

    Nov 18, 2014, 00:00 by Michael Croft
    Reuters | Just a day after Merck reported strong results from its IMPROVE-IT Vytorin trial, Regeneron presented its own clinical trial saying its drug helped 10 times as many patients lower their LDL.
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  • Cardiac Outcomes Trial Shows Drug Benefit, Research Direction

    Nov 17, 2014, 12:00 by Michael Croft
    Forbes | Results of a seven year cardiac outcomes study were announced today. The IMPROVE-IT trial of Merck's Vytorin versus simvastatin showed that Vytorin does improve outcomes.
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  • Medidata Collaborates with GlaxoSmithKline on Mobile Health Initiative to Test Novel Technology for Clinical Trial Optimization

    Nov 17, 2014, 00:00 by Michael Croft
    NEW YORK, NY, UNITED STATES OF AMERICA - Nov 17, 2014 - Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the completion of a method development project conducted in partnership with GlaxoSmithKline plc (GSK) to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting
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  • CISCRP Collaborates With ACRP for Medical Heroes 5K Run in Salt Lake City, Utah

    Nov 14, 2014, 00:00 by Michael Croft
    BOSTON, MA, UNITED STATES - Nov 14, 2014 - The Center for Information and Study on Clinical Research Participation  (CISCRP) and the Association for Clinical Research Professionals (ACRP), two independent non-profit organizations, are excited to announce the upcoming Medical Heroes Appreciation 5K Run & Walk in Salt Lake City to celebrate the volunteers who give the gift of participation in clinical research and to raise awareness about the importance of clinical research in advancing public health
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  • Clinical Trial to Test How Patients Use Genetic Information

    Nov 13, 2014, 13:00 by Michael Croft
    Clinical Informatics News Brief | On Monday, the Icahn School of Medicine at Mount Sinai’s Institute for Personalized Medicine announced a new clinical study to determine how knowledge of a genetic predisposition effects lifestyle changes.
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  • Clinical Trials for Ebola to Launch Next Month

    Nov 13, 2014, 09:00 by Michael Croft
    PharmaTimes | Medicins Sans Frontieres (Doctors Without Borders) plans to host clinical trials in three of its Ebola treatment centers in West Africa next month.
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  • AMC Health Partners with Icahn School of Medicine on Televideo-Enabled Prostate Cancer Clinical Trial

    Nov 12, 2014, 00:00 by Michael Croft
    NEW YORK, NY, UNITED STATES - Nov 12, 0014 - Today, AMC Health announced the first patient enrolled in a prostate cancer clinical trial deploying televideo, at Mount Sinai’s Icahn School of Medicine in Manhattan
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  • New Rules for Clinical Trials in China

    Nov 10, 2014, 08:00 by Michael Croft
    Outsourcing Pharma | The Chinese government implemented additional regulations last month for clinical trials and the hospitals that conduct them. The new measures--Administrative Measures for the Clinical Study Projects of Medical Institutions--supplement current research regulations
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  • EHR Audits to Increase Next Year

    Nov 7, 2014, 10:00 by Michael Croft
    Healthcare IT News | The Office of the Inspector General will focus on EHR fraud in 2015, the office's work plan reveals, which means more EHR audits for groups who have received EHR incentive payments from CMS and their business associates.
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  • Foundation Medicine's Data Experiment to Prove Clinical Utility

    Nov 6, 2014, 12:00 by Michael Croft
    Clinical Informatics News | Foundation Medicine highlighted several recent industry wins yesterday including a data partnership that it hopes will further prove the business case for the company’s two cancer diagnostic panel.
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  • The Dangers of Early Detection

    Nov 6, 2014, 10:15 by Michael Croft
    New York Times | In South Korea, aggressive screening for thyroid cancer has increased diagnoses fifteen-fold in just twenty years — illustrating the hidden risks and costs of seemingly benign early detection programs.
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  • October Clinical News and Product Briefs

    Nov 4, 2014, 10:35 by Michael Croft
    Clinical Informatics News | News and product releases from around the industry, including Geisinger Health System's 100,000 patient sequencing initiative, and IBM's Watson supercomputer at the Cleveland Clinic.
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  • Medidata and PPD Partner to Offer New Approach to Risk-Based Monitoring

    Nov 4, 2014, 00:00 by Michael Croft
    NEW YORK, NY - Nov 4, 2014 - Medidata (NASDAQ: MDSO), a leading global provider of cloud-based solutions for clinical research in life sciences, and Pharmaceutical Product Development, LLC (PPD), a global contract research organization (CRO), today announced they are expanding their partnership to provide the life science industry with a more comprehensive approach to risk-based monitoring (RBM)—aimed at conducting drug development more intelligently, more quickly and more cost-effectively
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  • Mobile Health at the Global Pediatric Innovation Summit

    Nov 3, 2014, 11:05 by Michael Croft
    Clinical Informatics News | At Boston Children's Hospital's second annual Global Pediatric Innovation Summit, a panel discussion on mobile and digital health took an optimistic, even futurist stance to the promise of technology, but also stressed the role of changing the culture of care providers in implementing real improvements.
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