United States

NIH awards $55M to build million-person precision medicine study

Thursday, July 7, 2016

The NIH has announced $55 million in awards in fiscal year 2016 to build the foundational partnerships and infrastructure needed to launch the Cohort Program of President Obama’s Precision Medicine Initiative (PMI). The PMI Cohort Program is a landmark longitudinal research effort that aims to engage 1 million or more U.S. participants to improve our ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics.

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AbbVie’s Humira receives FDA approval for non-infectious intermediate, posterior and panuveitis

Tuesday, July 5, 2016

The FDA has approved AbbVie’s Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with noninfectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for Humira in the U.S. for immune-mediated diseases.

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Veristat continues expansion in North Carolina

Friday, July 1, 2016

Veristat, a full service CRO with over 20 years of experience, is continuing its accelerated growth and geographic expansion with the opening of an office in Raleigh-Durham, North Carolina. In addition to this newly planned North Carolina office, Veristat has additional North American-based offices in Southborough, Massachusetts, Cambridge, Massachusetts, San Bruno, California, Montreal, Canada, and its European office in Glasgow, U.K.

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EMA, FDA reinforce collaboration on patient engagement

Tuesday, June 28, 2016

The EMA and the FDA have set up a new ‘cluster’ on patient engagement. The cluster will provide a forum to share experiences and best practices on the way the two agencies involve patients in development, evaluation and post-authorization activities related to medicines.

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