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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.
Nov 21, 2014
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New Rules for Clinical Trial Results Disclosure
Nature News | Regulations proposed yesterday would increase clinical trial transparency.
Nov 20, 2014
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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.
Nov 19, 2014
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$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.
Nov 18, 2014
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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.
Nov 18, 2014
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Cardiac Outcomes Trial Shows Drug Benefit, Research Direction
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.
Nov 17, 2014
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Clinical Trial to Test How Patients Use Genetic Information
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.
Nov 13, 2014
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Clinical Trials for Ebola to Launch Next Month
PharmaTimes | Medicins Sans Frontieres (Doctors Without Borders) plans to host clinical trials in three of its Ebola treatment centers in West Africa next month.
Nov 13, 2014
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New Rules for Clinical Trials in China
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
Nov 10, 2014
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EHR Audits to Increase Next Year
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.
Nov 7, 2014
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Foundation Medicine's Data Experiment to Prove Clinical Utility
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.
Nov 6, 2014
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The Dangers of Early Detection
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.
Nov 6, 2014
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October Clinical News and Product Briefs
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.
Nov 4, 2014