Skip to content

Category: In the News

The ASCO Post – COVID-19 Evidence Accelerator Leverages Real-World Data

The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) in collaboration with Friends of Cancer Research recently announced the COVID-19 Evidence Accelerator, an expansive public-private partnership combining the efforts of academic, government, and private sector organizations applying data analytics to accelerate the understanding of COVID-19.   “We are honored to be launching this…

The ASCO Post – ASCO’s President-Elect Aims to Ensure Equitable Cancer Care for Every Patient

The desire to pursue a career in medicine took root when Lori J. Pierce, MD, FASTRO, FASCO, was a young child visiting family in segregated Ahoskie, North Carolina. She witnessed firsthand the impact the town’s lone African American family physician had on the community.   When it came time to choose a medical specialty, while…

Pink Sheet – Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets

Executive Summary 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 data sets was key for FDA in selecting the the partnership, which grew from Reagan-Udall Foundation…

Mass Device – FDA launches COVID-19 research initiative

The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19.   The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according…

Regulatory Focus – Multinational efforts build framework for real-world and observational COVID-19 data

International regulators will increase cooperation for observational studies conducted in three key eras during the coronavirus pandemic. Building a strong infrastructure to monitor vaccine safety and effectiveness, putting together international clinical cohorts of patients with COVID-19 infection and pregnancy research were identified as priority areas for cooperation during a workshop held 19 May 2020 under…

POLITICO PRO -Q&A: FDA Principal Deputy Commissioner Amy Abernethy

FDA this week announced a project with health tech company Aetion to track and analyze Covid-19 treatments and diagnostics in a bid to better understand what works — and what doesn’t.   The new partnership with Aetion — where former Commissioner Scott Gottlieb sits on the board — is part of an “all hands on…

STAT – FDA, partnering with New York health tech firm, seeks to collect ‘real-world’ data on Covid-19

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, including how diagnostics and medications are being used in the pandemic and how best…

Regulatory Focus – FDA, Aetion partner on real-world data analytics for COVID-19

The US Food and Drug Administration (FDA) on Tuesday said it will partner with New York-based health technology firm Aetion, Inc. to develop real-world data analytics to answer pressing questions related to coronavirus disease (COVID-19). “Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms,…

Bloomberg Law – FDA Teams Up With Data Company Aetion to Study Virus Progression (1)

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.   The Food and Drug Administration is already using its internal drug monitoring system called Sentinel to learn more…

STAT – Biotech’s new chief lobbyist says she’s a social justice advocate. Will the industry walk the walk?

Michelle McMurry-Heath doesn’t talk about biotech the way her peers do.   Where other executives and experts might bring up “access,” and “reimbursement,” McMurry-Heath talks about fairness and ethics.   “Science is the social justice issue of our age,” McMurry-Heath said. “Making sure that knowledge gets out to the people who need it, that, to…