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Unpacking the Clinical Genome
Clinical Informatics News | The Clinical Genome Conference, now in its third year, was held in San Francisco June 10-12. The program explored a wide range of issues facing genomics in the clinic including the payer process, genome interpretation software, clinical utility and integration, references and standards, and communicating findings to the patient. Here are some of the highlights from the event.
Jun 23, 2014
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FDA Releases Social Media Draft Guidances
Clinical Informatics News | The FDA has finally released two draft guidances on how companies should deal with social media including comments posted on Twitter and third party blogs and sponsored links on search engines such as Google and Yahoo.
Jun 17, 2014
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Updated DIA News and New Products
Clinical Informatics News | Lots of product news coming out of the Drug Information Association annual meeting that started today in San Diego. Here are some of the highlights.
Jun 16, 2014
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May-June Clinical News and Product Briefs
Clinical Informatics News | Clinical news and product releases from around the industry, including Eli Lilly's new clinical trial transparency commitments, and Aptiv Solutions' latest adaptive dose response software for Phase 1 clinical trials.
Jun 13, 2014
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Public Databases Aim to Match Myriad's Closely-Held Knowledge of BRCA Mutations
Nature News | In the effort to empower clinical geneticists with reliable public data on which genetic variants should be labeled pathogenic, mutations to the breast cancer-related BRCA1 and BRCA2 genes have been among the heaviest points of contention.
Jun 11, 2014
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Novartis Acknowledges Huge Lapse in Clinical Trial Safety Reporting
WSJ Pharmalot | Following revelations in April that Novartis employees in Japan had concealed unfavorable safety reports in clinical trials, the pharmaceutical company has now disclosed that the problem was much more widespread than was previously realized.
Jun 11, 2014
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Health Data for All: Maximizing Health Data for Both Business and Patient
Clinical Informatics News | Transparency, data sharing, and the inclusion of patient voices were all major themes at last week's Healthdatapalooza event in Washington, D.C.
Jun 9, 2014
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Geisinger to Open Telemedicine Center for Genetic Testing
Clinical Informatics News Brief | Geisinger Health Systems, one of the country's largest provider networks, yesterday announced the construction of a new facility in Forty Fort, PA, to provide patients with remote consultations around DNA diagnostics.
Jun 6, 2014
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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