Blog
The case for regulator-HTA collaboration on RWE methodology standards
Regulatory and health technology assessment (HTA) bodies have announced their commitment ...
Blog
Trends and predictions for RWE: Perspectives from Dr. Sean Hennessy, pharmacist and pharmacoepidemiologist
Sean Hennessy, Pharm.D., Ph.D., is a pharmacist and pharmacoepidemiologist who feels he ...
Blog
Q&A with Dr. Nicolle Gatto: Leveraging external comparators for drug development and COVID-19 research
Nicolle Gatto, Ph.D., is the Senior Vice President of Scientific Research at Aetion, ...
FDA Decision Alert
CDER-Approved NDA for ExEm® Foam (air polymer-type A) intrauterine foam
On November 7, 2019, the FDA granted approval of Giskit B.V.’s ExEm® Foam (air ...
Blog
The causal revolution in observational research: Breaking the causality taboo
As interest in real-world evidence (RWE) increases, the conversation often focuses on the ...
Blog
How can biopharma use oncology real-world data to support clinical development? Q&A with Viraj Narayanan, VP of Life Sciences, COTA
In oncology, real-world data (RWD) has emerged as an important tool to support clinical ...
Blog
COVID-19: The critical role of real-world evidence made real
In the article below, originally published in HLTH Matters, Carolyn Magill, CEO of ...
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 ...