Blog Post by Admin
FDA Decision Alert
Jul 23, 2020
CDER-Approved NDA for TABRECTA™ (capmatinib hydrochloride)
On May 6, 2020, the FDA approved Novartis’s TABRECTA™ (capmatinib hydrochloride) for ...
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Blog
Jul 21, 2020
How to generate insights on COVID-19 interventions with real-world data: Three learnings from the COVID-19 Therapeutics Evidence Accelerator
The COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA ...
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Blog
Jul 17, 2020
What’s ahead for the use of RWE by regulators and HTAs? Q&A with Dr. Lucinda Orsini, Associate Chief Science Officer of ISPOR
Lucinda Orsini, D.P.M., M.P.H., has decades of experience working with biopharma, ...
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Blog
Jul 10, 2020
Financing innovative therapies in the era of COVID-19: The collaborative work ahead
Much discussion surrounds how our society will pay for curative and high cost therapies, ...
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Blog
Jun 25, 2020
The case for regulator-HTA collaboration on RWE methodology standards
Regulatory and health technology assessment (HTA) bodies have announced their commitment ...
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Blog
Jun 18, 2020
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 ...
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Blog
Jun 12, 2020
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, ...
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FDA Decision Alert
Jun 11, 2020
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 ...
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Blog
Jun 4, 2020
The causal revolution in observational research: Breaking the causality taboo
As interest in real-world evidence (RWE) increases, the conversation often focuses on the ...
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Blog
May 27, 2020
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 ...
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Blog
May 21, 2020
COVID-19: The critical role of real-world evidence made real
In the article below, originally published in HLTH Matters, Carolyn Magill, CEO of ...
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Presentation
May 20, 2020
What We Learned About Data Synthesis in 2020
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Blog
May 14, 2020
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 ...
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Blog
May 8, 2020
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 ...
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Blog
Apr 29, 2020
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 ...
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Blog
Apr 23, 2020
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 ...
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Blog
Apr 21, 2020
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 ...
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Apr 21, 2020
CBER-Approved BLA for ZOLGENSMA (onasemnogene abeparvovec-xioi)
On May 24, 2019, the FDA approved AveXis’s ZOLGENSMA® (onasemnogene abeparvovec-xioi), ...
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Apr 20, 2020
CDER-Approved NDA for LUTATHERA® (lutetium Lu 177 dotatate)
On January 26, 2018, the FDA granted approval to Advanced Accelerator Applications USA, ...
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FDA Decision Alert
Apr 20, 2020
CDER-Approved NDA for pretomanid tablets
On August 14, 2019, the FDA approved TB Alliance’s pretomanid tablets as part of a ...
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FDA Decision Alert
Apr 20, 2020
CDER-Approved NDA for SCENESSE® (afamelanotide 16mg)
On October 8, 2019, the FDA granted approval to Clinuvel Pharmaceuticals Limited’s ...
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FDA Decision Alert
Apr 20, 2020
CDER-Approved NDA for WAKIX® (pitolisant) tablets
On August 14, 2019, the FDA approved Harmony Biosciences’ WAKIX® (pitolisant) tablets, ...
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FDA Decision Alert
Apr 20, 2020
CDER-Approved NDA for EGATEN™ (triclabendazole)
On February 13, 2019, the FDA approved Novartis’ EGATEN™ (triclabendazole), which was ...
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FDA Decision Alert
Apr 20, 2020
CDER-Approved BLA for Jeuveau™ (prabotulinumtoxinA-xvfs)
On February 1, 2019, the FDA approved Evolus, Inc.’s Jeuveau™ (prabotulinumtoxinA-xvfs), ...
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