Coverage

A New Trend in Drug Development: Leveraging Data from Expanded Access - Cancer Therapy Advisor
A manuscript detailing this study is under revision and awaiting acceptance by the British Journal of Clinical Pharmacology.  The study was funded using an unrestricted grant from myTomorrows, a global company that connects patients to expanded access…
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WHEN YOU DON’T QUALIFY FOR A CLINICAL TRIAL: EXPANDED ACCESS MIGHT HELP - Triage Cancer
When dealing with a cancer diagnosis, often times the best form of treatment can be offered through a clinical trial. We de-bunked common myths in this blog post, talking about the benefits of considering clinical trials, in efforts to shift the…
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Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets - Pinksheet
FDA's Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens. Aetion's ability to perform consistent analyses across a variety of…
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Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response
Today, we are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical…
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FDA Teams Up With Data Company Aetion to Study Virus Progression - Bloomberg Law
The FDA said Tuesday it’s pairing up with the data company Aetion to research Covid-19 complications and what types of medicines virus patients are taking, which could help researchers learn more about which treatments are effective.
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FDA, partnering with New York health tech firm, seeks to collect ‘real-world’ data on Covid-19 - STAT
The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine — to learn more about Covid-19…
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A New, Better Normal in Health Care? - National Review
The COVID-19 crisis has fast-tracked long-contemplated, patient-centric changes in medicine.
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BioCentury This Week: Special Edition - Getting Real about COVID-19 Data
Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, described in podcast interviews with BioCentury’s Washington Editor Steve Usdin how the…
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Health, Defense Agencies Should Cooperate to Beat COVID-19 - RealClearHealth
The U.S. has been trying to contain COVID-19 through testing and social distancing. Now it’s time to kill it. What’s needed is intragovernmental cooperation, something that, sadly, is rare in the nation’s capital. In this case, Congress and the Trump…
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Beyond the Magic Bullet: Medical Progress Is Often Incremental - National Review
Life won’t completely return to normal while the novel coronavirus remains a threat to health and to life. More than 60,000 Americans have already lost their lives to this virus; while older people seem especially vulnerable, the virus has demonstrated…
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