Whether the astonishing missteps by Sequenom, which earlier this year disclosed it could not support its data for a non-invasive Down Syndrome test, were merely poor management or a reality check for the field of non-invasive prenatal disgnostics, the NIPD opportunity is compelling. But the profession also understandably balks at obtaining information that is not then clinically actionable -- an issue that could further amplify in importance as technologies like microarrays and direct DNA sequencing increase become more prevalent.
by Mark L. Ratner
It remains to be seen whether the astonishing missteps by Sequenom Inc., which earlier this year disclosed that it...
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
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J&J's EMEA head of digital solutions, Julia Fishman, talks about the hurdles in scaling digital innovation and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.
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