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A Dramatic Case of Clinical Pathogen Detection through Gene Sequencing
New York Times | A new, ultra-rapid method of pathogen detection from DNA samples has been used to diagnose, and ultimately cure, a life-threatening case of encephalitis that had led doctors to place a 14-year-old boy in a medically induced coma.
Jun 5, 2014
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European Ombudsman Shares Her Views of Ongoing EMA Transparency Controversy
WSJ Pharmalot | Ed Silverman, whose popular Pharmalot blog was revived this week in a new home at the Wall Street Journal, has published an interview with European Ombudsman Emily O'Reilly about her criticisms of the European Medicines Agency.
Jun 5, 2014
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OpenFDA to Encourage Public Scrutiny of Health Data
Clinical Informatics News Brief | This Monday, the FDA opened access to the beta version of openFDA, a web portal designed to make it easier for the public to access and search through medical data already collected by the agency.
Jun 3, 2014
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Pathway Genomics Launches New BRCA Test and One for One Test Donation Program
Clinical Informatics News | Pathway Genomics has launched its BRCATrue test for BRCA 1 and BRCA 2 and its BRCA One for One program, hoping to offer the industry’s best BRCA genetic test and make it accessible to a wide range of women.
Jun 3, 2014
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Spark Raises $73 Million to Shepherd Gene Therapy through Phase 3 Trials
Clinical Informatics News | Spark Therapeutics, a gene therapy company pursuing a Phase 3 clinical trial to treat a progressive retinal disorder, this week announced a Series B funding round that co-founder and CEO Jeff Marrazzo says will put the company on solid footing through an FDA decision on its lead therapy.
May 30, 2014
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European Medicines Agency, Seen as Undermining Transparency, Applauds New Regulations
Clinical Informatics News Brief | This week's publication of new European rules on clinical trial transparency have prompted renewed scrutiny of the EMA, which critics accuse of backing down on commitments to public access to trial data.
May 28, 2014
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For Students at the Icahn School of Medicine, Genomics Is Growing More Personal
Clinical Informatics News | The Icahn School of Medicine at Mt. Sinai is experimenting with new ways to bring genomics closer to medical education – all the way up to sequencing students' whole genomes.
May 23, 2014
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Patient Recruitment: A Protocol Problem?
Philadelphia Inquirer | Patient recruitment is a fundamental challenge in clinical trials, and a study's design can have a significant impact on patient retention and recruitment.
May 22, 2014
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Clinical Challenge: Lilly’s Design Challenges Take on Patient User Experience
Clinical Informatics News | In its continuing effort to make clinical trials more patient-centric and to improve the time, cost, and efficiency of developing new treatments, Eli Lilly and Company announced the winners of its second Open Clinical Trial challenge.
May 21, 2014
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Navigating Rare Diseases: New Platform Aims to Connect Patients with Rare Diseases to Hospitals
Clinical Informatics News | CurityMD is a new platform striving to inform patients with rare diseases about the specialists, treatment options, clinical trials, and hospitals around the country that can best meet their needs. The CurityMD platform lets patients search by condition and drill down by geographic location, ranked hospitals, and centers with ongoing clinical trials.
May 19, 2014
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PHT Releases App for Navigating FDA Guidelines on Patient-Focused Outcomes
Clinical Informatics News Brief | The FDA Roadmap App from PHT Corporation is build to help sponsors design clinical trials around patient-reported outcomes in compliance with FDA recommendations.
May 15, 2014
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New Payment Transparency Commitment from Top Three Insurers
Modern Healthcare | This week, the nation's three largest health insurance providers, UnitedHealthcare, Aetna, and Humana, made public a commitment to share payment information on a freely available online database.
May 15, 2014