Presentation
What We Learned About Data Synthesis in 2020
Blog
FDA vaccine approval and common self-controlled study designs for vaccine safety testing
Across the United States, a patchwork of communities have begun to lift the stay-at-home ...
Blog
HTAs and RWE: Current use, predicted trends, and next steps for biopharma
In recent years, technological advances have both expanded the amount and availability of ...
Blog
Priorities for modernizing ClinicalTrials.gov: Five ideas to facilitate transparency in observational research
ClinicalTrials.gov (CT.gov) is the largest public clinical registry and results database ...
Blog
Real-world evidence and COVID-19: Empower rapid, reliable, data science-driven decisions
The COVID-19 pandemic has triggered intense and widespread action among the biopharma ...
Blog
The surge in RWE supported FDA approvals: A look at three FDA decisions
The U.S. Food and Drug Administration (FDA) is approving more drugs with the help of ...
CBER-Approved BLA for ZOLGENSMA (onasemnogene abeparvovec-xioi)
On May 24, 2019, the FDA approved AveXis’s ZOLGENSMA® (onasemnogene abeparvovec-xioi), ...
CDER-Approved NDA for LUTATHERA® (lutetium Lu 177 dotatate)
On January 26, 2018, the FDA granted approval to Advanced Accelerator Applications USA, ...
FDA Decision Alert
CDER-Approved NDA for pretomanid tablets
On August 14, 2019, the FDA approved TB Alliance’s pretomanid tablets as part of a ...
FDA Decision Alert
CDER-Approved NDA for SCENESSE® (afamelanotide 16mg)
On October 8, 2019, the FDA granted approval to Clinuvel Pharmaceuticals Limited’s ...
FDA Decision Alert
CDER-Approved NDA for WAKIX® (pitolisant) tablets
On August 14, 2019, the FDA approved Harmony Biosciences’ WAKIX® (pitolisant) tablets, ...
FDA Decision Alert
CDER-Approved NDA for EGATEN™ (triclabendazole)
On February 13, 2019, the FDA approved Novartis’ EGATEN™ (triclabendazole), which was ...
FDA Decision Alert
CDER-Approved BLA for Jeuveau™ (prabotulinumtoxinA-xvfs)
On February 1, 2019, the FDA approved Evolus, Inc.’s Jeuveau™ (prabotulinumtoxinA-xvfs), ...
Blog
Optimizing pharma organizational design for effective use of real-world evidence
Across the pharma product lifecycle, factors like the regulatory environment and business ...
Blog
How RWE can inform cancer care: Q&A with Dr. Deb Schrag, oncologist and observational researcher
Real-world evidence (RWE) has emerged as a useful tool for industry and regulators in ...
Blog
How can you leverage RWE to help advance your organization’s goals? Q&A with Dr. Yin Ho
Trained as an emergency medicine physician, Yin Ho, M.D., M.B.A., stepped out of the ...
Blog
How to plan for evidence generation in a time of uncertainty
Much of my time lately has been dedicated to contemplating the magnitude of COVID-19’s ...
Presentation
Empirical Assessment of Privacy Risks in Data
Blog
COVID-19: Recommended readings and resources from Aetion scientists
Over the past few weeks, we’ve been adjusting to the many changes and uncertainties ...
Blog
Making the business case for RWE: Julie Schiffman’s advice for biopharma on leveraging data to drive impact
How can teams within biopharma ensure their real-world evidence (RWE) studies make the ...
Blog
Psychiatrist and health care CEO Dr. Gary Gottlieb: Treating the patient as a whole person
With his previous professional experience ranging from CEO of Massachusetts-based ...
Blog
Aetion, Dr. Scott Gottlieb, biopharma leaders’ discussions at JPM 2020: It’s time to “knock on an open door” to further RWE standards and acceptance
This January, in the whirlwind week of the 36th Annual J.P. Morgan Healthcare Conference ...
Blog
How to amplify RWE clarity and reproducibility with data visualizations: Q&A with Dr. Shirley Wang of the REPEAT initiative
While analyses of non-randomized health care databases—insurance claims, electronic ...
Blog
Artificial Intelligence in Health Care - GAO Report
Benefits and Challenges of Machine Learning in Drug Development The adoption of ...