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DAILY NEWS

Holiday Reading – The FDA’s Busy Year
TODAY | Clinical Informatics News | The “drug” half of the Food and Drug Administration has been reexamining its role in a changing industry this year, reevaluating both how it reviews new kinds of biotech diagnostics, and where it fits in a healthcare system that has increasingly probed the limits of FDA oversight. Here are some of the big stories to come out of the FDA this year. more

Connecting Fitness Data to Health
TODAY | Forbes | Are consumers really taking their fitness device data to their doctors? Survey says No. more

CROs mostly positive on rule to make clinical trials transparent
| Outsourcing-Pharma.com | Last week, the NIH and FDA proposed measures that would require the release of summary results of clinical trials for products that are unapproved or unlicensed. CROs have expressed some concern about the transparency initiatives, but were mostly positive. more

Apotex Sues Health Canada Over an ‘Unlawful’ Ban on its Drugs
| 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. more

New Rules for Clinical Trial Results Disclosure
| Nature News | Regulations proposed yesterday would increase clinical trial transparency. more

PHT Releases Electronic Neuropsychiatric Interview, Rater Training
| 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. more

$2.6 Billion Drugs, Or Not
| 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. more

Regeneron Drug Lowers LDL for Patients Who Cant Take Statins
| 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. more


PRESS RELEASES
Can Artificial Intelligence Solve the $55 billion Problem of Opioid Abuse?(2)
| NEW YORK, NY - Nov 24, 2014 - AiCure, an artificial intelligence company providing advanced facial recognition and motion-sensing technology to monitor medication ingestion, has announced the start of a major clinical trial to monitor and intervene with patients receiving medication as maintenance therapy for opioid addiction more

Can Artificial Intelligence Solve the $55 billion Problem of Opioid Abuse?
| NEW YORK, NY - Nov 24, 2014 - AiCure, an artificial intelligence company providing advanced facial recognition and motion-sensing technology to monitor medication ingestion, has announced the start of a major clinical trial to monitor and intervene with patients receiving medication as maintenance therapy for opioid addiction more

Definiens Predicts Biggest Drivers for Personalized Medicine in 2015: Data Quality, Immunotherapy, Combination Treatments and Predictive Biomarkers
| 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 more

Clinverse, Inc. Names Seasoned Industry Veteran as Chief Commercial Officer
| 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 more

Medidata Collaborates with GlaxoSmithKline on Mobile Health Initiative to Test Novel Technology for Clinical Trial Optimization
| 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 more

CISCRP Collaborates With ACRP for Medical Heroes 5K Run in Salt Lake City, Utah
| 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 more

AMC Health Partners with Icahn School of Medicine on Televideo-Enabled Prostate Cancer Clinical Trial
| 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 more

Medidata and PPD Partner to Offer New Approach to Risk-Based Monitoring
| 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 more



 

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