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Esperion Therapeutics Sees Clear FDA Path For Its Heart Drug
Forbes | Esperion Therapeutics says the Food and Drug Administration has agreed that the company's medicine, bempadoic acid, could be approved based on blood test results, before a larger study proving it prevents heart attacks, strokes, heart procedures, or deaths has been completed.
Mar 21, 2017
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When Hospital Inspectors Are In Town, Fewer Patients Die, Study Says
STAT | Researchers said that at major teaching hospitals, about 3,600 deaths in one year could be avoided if inspection-related vigilance was the norm.
Mar 20, 2017
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Pricey Drug Cuts Cardiovascular Risk — But Will Insurers Pay?
STAT | Amgen's cholesterol drug lowered risk of cardiovascular trouble in a huge clinical trial - but the results may not be good enough for insurers to cover.
Mar 17, 2017
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With FDA’s Blessing Seres Preps New “Pivotal” Microbiome Drug Trial
Xconomy | Seres Therapeutics wants to become the first company to bring to market a drug that targets the microbiome. Its lead drug failed in clinical trials last year, but now the company is launching a new Phase 2 trials.
Mar 16, 2017
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Johnson & Johnson Invests More Data In YODA Project
Clinical Informatics News | Johnson & Johnson has shared pharmaceutical and medical device data through the Yale University Open Data Access (YODA) Project, promoting scientific discovery and data transparency along the way.
Mar 15, 2017
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Tom Price Expresses Concern On Genetic Testing Bill
STAT | Tom Price suggested that there would be "significant concerns" with a House bill that would allow companies to require employees to undergo genetic testing.
Mar 13, 2017
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Seattle Genetics To Resume Trials As FDA Lifts Clinical Hold
Reuters | Seattle Genetics said on Monday the U.S. Food and Drug Administration lifted a clinical hold on several early stage studies testing its experimental cancer drug.
Mar 6, 2017
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The Remote Clinical Trial Concept In Clinical Research – Definition And Opportunities
Clinical Informatics News | The pharmaceutical industry has generally remained behind the curve when implementing digital health technologies and interacting with patients within the context of clinical trials. Remote trials provide an interesting spin on the use of digital health components to enhance the patient experience.
Mar 2, 2017