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CROS NT launches RaveX as part of Medidata extended partnership


CenterWatch : May 24, 2017 9:50 am : Centerwatch, CROS NT, CROs/Service Providers, Global News, Medidata

CROS NT announced the go-live of its RaveX team in an extension of the company’s partnership with Medidata. Under the partnership, CROS NT will offer its customers RaveX—the latest generation of Medidata’s EDC system, Medidata Rave—as well as Medidata’s randomization and trial supply management (RTSM) system, Medidata Balance. The Data Management division in CROS NT […]

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IBM, tranSMART Foundation bring translational medicine data to scientists


CenterWatch : May 24, 2017 9:46 am : Centerwatch, Global News, IBM, Technology Solutions, tranSMART Foundation

The tranSMART Foundation, a nonprofit organization providing a global, open-source, open-data knowledge management platform for scientists to share pre-competitive translational research data, and IBM announced a collaboration and the general availability of the tranSMART platform (version 16.2) on IBM Power8 servers. The translational research platform is running on IBM Power8 servers at the tranSMART Foundation’s […]

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AstraZeneca show positive results in phase III ZONDA trial severe asthma


CenterWatch : May 23, 2017 3:10 pm : AstraZeneca, Centerwatch, Clinical Intelligence, Global News

Results from AstraZeneca‘s phase III ZONDA trial demonstrated that adding benralizumab to standard-of-care allowed patients dependent on OCS to significantly reduce or discontinue steroids while maintaining asthma control. Detailed results of the ZONDA study were published in the New England Journal of Medicine. The trial achieved its primary efficacy endpoint, demonstrating statistically-significant and clinically relevant reduction […]

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bluebird bio, Duke collaborate on value-based payment framework for gene therapy


CenterWatch : May 23, 2017 2:59 pm : bluebird bio, Centerwatch, Duke University, Global News, R&D Trends

bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, announced that it will participate in a consortium led by Duke University’s Robert J. Margolis, M.D., Center for Health Policy to develop a broadly-supported path for value-based payment reform models for gene therapies and other […]

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Otsuka, Proteus Digital Health resubmit FDA application for first digital medicine


CenterWatch : May 23, 2017 2:54 pm : Centerwatch, Clinical Intelligence, Otsuka Pharmaceutical, Proteus Digital Health, United States

Otsuka Pharmaceutical and Proteus Digital Health announced that the FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The NDA resubmission will now be reviewed by the FDA, with an anticipated action date by the agency in […]

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