FDA approval and regulation of medical devices: a primer

This article gives an overview of medical device classification in the U.S. and of the regulations governing the FDA’s review of application to market medical devices.

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When competitive intelligence is predictive rather than reactive, biopharma companies can grab the edge

In the dynamic global biopharma landscape, competitive intelligence (CI) is as indispensable as ever.

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NGS, maybe, sort of, sometimes clinic ready

Detailed genomic profiling is a sine qua non of precision medicine, and at tertiary cancer centers, the comprehensive profiling of tumors and matched germline DNA is becoming ever more routine.

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Cortellis M&A Landscape: Notable mergers & acquisitions of Q1 2017

The mergers and acquisitions (M&A) activity in the Life Sciences sector in the first quarter of 2017 continued to progress like previous periods. In the first months of the year, 126 active M&A deals were reported by Clarivate Cortellis Deals Intelligence with a total disclosed value of $76 billion.

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Positive outlook for CDMOs at CPhI North America, but companies need to be ready for challenges

CPhI North America, running concurrently with InformEx, is a new addition to the global series of CPhI events.

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