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DAILY NEWS

A New Initiative on Precision Medicine
| New England Journal of Medicine | Francis Collins and Harold Varmus discuss the President's Personalized Medicine Initiative. more

New FDA Powers, Responsibilities in Draft 21st Century Cures Act
| Clinical Informatics News Brief | The House Committee on Commerce and Energy has published a draft version of the 21st Century Cures Act, a sweeping bill containing numerous changes to the FDA's powers to review and approve drugs and medical devices. more

Drug Prices Rose Across Classes in 2014
| Clinical Informatics News Brief | This week the Truveris National Drug Index released its first full year figures. In 2014, generic and specialty drugs combined rising 10.9%. Brand drug prices spiked 14.8%, while specialty drug prices jumped 9.7%. Generics, historically intended to curb costs, are contributing to prescription price inflation, increasing 4.9% last year.  more

In Defense Department's Health IT Overhaul, a Crossroads for American Healthcare
| Clinical Informatics News | As the Department of Defense considers bids to replace its legacy EHR system with a modernized solution, it stands to create the nation's largest interconnected health IT system. That could have big repercussions for the future of EHR interoperability, population health, and coordinated care in the military and across the country. more

HHS Marks Goals for Alternative Payment Models
| Clinical Informatics News Brief | Secretary of Health and Human Services Sylvia Mathews Burwell today published a letter in the New England Journal of Medicine outlining near-term goals for influencing the direction of U.S. healthcare. more

PHT Expands Rater Training Program
| Clinical Informatics News Brief | PHT Corporation is expanding its rater training program that it first launched in November. more

Bill is Introduced to Provide Added Exclusivity for Fixed-Dose Drugs
| WSJ | A bill was introduced in Congress last week that is designed to alleviate frustration drug makers have felt over a recent FDA guidance concerning fixed-dose combination drugs. more

EMA Recommends Hundreds of Drugs to be Suspended Over ‘Flawed Studies’
| WSJ | European regulators recommend suspending the sale of hundreds of drugs that were authorized for use across the continent based on "flawed" clinical studies that were conducted by GVK Biosciences, a clinical research organization based in India. more


PRESS RELEASES
Spaulding Clinical Research, LLC Receives CRO Leadership Award
| WEST BEND, WI - Dec 1, 2014 - Spaulding Clinical Research, LLC ("Spaulding Clinical"), a recognized leader in Clinical Research and Device Manufacturing, announced that it has received CRO Leadership Awards in the following categories: Quality, Innovation, Productivity, and Regulatory more

Rho Showcases Clinical Services Expertise at OCT West Coast
| CHAPEL HILL, NC, UNITED STATES - Jan 27, 2015 - WHAT:  Rho, a full-service contract research organization (CRO), will highlight its continued success in drug development strategies and services during the Outsourcing in Clinical Trials (OCT) West Coast conference, being held February 3-4 in Burlingame, California more

PHT Corporation Delivers Unique Rater Training Programs to Improve Instrument Reliability, Data Quality and Outcomes
| BOSTON, MA, UNITED STATES - Jan 26, 2015 - The pharmaceutical industry is further optimizing the collection of high quality electronic patient reported outcomes (ePROs) data for clinical research, with PHT CorporationRater Training programs more

American Society for Cell Biology chooses TEMIS for Science Navigator application
| COLUMBIA & BETHESDA, MD - Jan 6, 2015 - Columbia, MD and  Bethesda, MD - January 6, 2015 -  TEMIS, the leading provider of Semantic Content Enrichment solutions for the Enterprise, today announced an extension of their collaboration with the American Society for Cell Biology (ASCB) to further hone the ASCB Science Navigator, a bespoke version of TEMIS Luxid® Navigator - Biopharma Edition, as a tool for biomedical research more

Synchrogenix, Certara’s Regulatory and Medical Writing Consultancy, Acquires ClinGenuity
| PRINCETON, NJ - Jan 6, 2015 - Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry more

Cancer Treatment Centers of America Selects WIRB-Copernicus Group to Facilitate the Expansion of its Clinical Research Program
| PRINCETON, NJ - Dec 15, 2014 - WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that it has been chosen by Cancer Treatment Centers of America® (CTCA) to help expand its clinical research program more

Definiens Releases Tissue Studio® 4.0 for Quantitative Digital Pathology
| MUNICH, GERMANY - Dec 10, 2014 - Definiens, the global leader in Tissue Phenomics® for oncology diagnostics, today announced the newest version of its leading image analysis software for quantitative digital pathology, Tissue Studio 4 more

Medidata Announces Availability of Patient Profiles Offering
| NEW YORK, NY - Dec 10, 2014 - Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the availability of its enriched solution for risk-based monitoring (RBM) of clinical trial sites more



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