Blog Post by Admin
Presentation
Nov 4, 2020
Optimal Synthesis of Clinical Trial Data
Khaled El Emam, SVP & GM, Replica Analytics
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Publication
Nov 2, 2020
Evaluating Identity Disclosure Risk in Fully Synthetic Health Data
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Publication
Nov 1, 2020
Optimizing the Synthesis of Clinical Trial Data Using Sequential Trees
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Blog
Oct 29, 2020
Generating real-world evidence from chargemaster data: Q&A with Myla Maloney of Premier, Inc.
Most real-world data (RWD) sets are based on claims data, which provides useful ...
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FDA Decision Alert
Oct 28, 2020
CDER-Approved sNDA for IBRANCE® (palbociclib)
On April 4, 2019, the FDA granted a label expansion to Pfizer’s IBRANCE® (palbociclib) ...
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FDA Decision Alert
Oct 28, 2020
CDER-Approved NDA for AYVAKIT™ (avapritinib)
On January 9, 2020, the FDA approved Blueprint Medicines Corporation’s AYVAKIT™ ...
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Blog
Oct 21, 2020
How can small- to mid-sized biopharma generate insights from RWD? Q&A with Michael Sanky of Optum Life Sciences
Optum, a new Aetion data collaborator, offers a robust range of real-world data (RWD) ...
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FDA Decision Alert
Oct 16, 2020
CDER-Approved NDA for KOSELUGO™ (selumetinib)
On April 10, 2020, the FDA approved AstraZeneca’s KOSELUGO™ (selumetinib) “for the ...
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Blog
Oct 15, 2020
Unlocking insights in RWD for market access and commercial teams: Q&A with Ki Park of Symphony Health
The integrated solutions of Symphony Health, a new Aetion data partner, extract data from ...
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Blog
Oct 1, 2020
ICPE research spotlight: Part II: Exploring new methods for RWE research
This year at ICPE All Access, Aetion’s scientific research is represented across 15 ...
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Blog
Sep 24, 2020
Ask the Accelerators: Dr. William Morice of Mayo Clinic Laboratories on RWE and COVID-19 diagnostics
Ask the Accelerators is a series highlighting the perspectives and work of organizations ...
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Blog
Sep 16, 2020
ICPE research spotlight: Part I: Expanding real-world applications of RWE
This year at ICPE All Access, Aetion’s scientific research is represented across 15 ...
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Sep 9, 2020
CDER-Approved NDA for NOURIANZ™ (istradefylline)
On August 27, 2019, the FDA approved Kyowa Kirin’s NOURIANZ™ (istradefylline), an adjunct ...
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Blog
Sep 3, 2020
Ask the Accelerators: Dr. Nirosha Lederer on COVID-19’s implications for the future of RWE, and what we’ve learned so far
Ask the Accelerators is a series highlighting the perspectives and work of organizations ...
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Blog
Aug 31, 2020
Three recommendations for generating regulatory-grade RWE: Considerations for the FDA on PDUFA VII
With the passage of the 21st Century Cures Act and the sixth Prescription Drug User Fee ...
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Blog
Aug 20, 2020
Structuring epidemiology teams to maximize impact of RWE: Q&A with Dr. Nicolle Gatto
Nicolle Gatto, Ph.D., is the Senior Vice President of Scientific Research at Aetion, ...
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FDA Decision Alert
Aug 14, 2020
CDER-Approved NDA for TAZVERIK™ (tazemetostat)
On January 23, 2020, the FDA approved Epizyme’s TAZVERIK™ (tazemetostat) for patients “16 ...
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Blog
Aug 13, 2020
How can AI and RWD work together to improve understanding of chronic diseases? Q&A with Kathryn Starzyk, Head of RWE at OM1
OM1, a new Aetion data partner, curates deep clinical real-world data (RWD) from ...
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Blog
Aug 6, 2020
Real-world evidence and regulatory decision-making: A round-up of readings on progress to date, and what’s to come
In recent years, the U.S. Food and Drug Administration (FDA) and other global regulatory ...
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Article
Aug 1, 2020
Seven Ways to Evaluate the Utility of Synthetic Data
The article published by IEEE Security & Privacy magazine emphasizes the crucial role ...
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Blog
Jul 30, 2020
Lessons from four recent FDA decisions in infectious disease
The use of real-world evidence (RWE) has proven pivotal to research in infectious ...
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Blog
Jul 23, 2020
The Cures Act’s second act: Six ways to ensure Congress doubles down on its boldest bet
In the article below, originally published in Morning Consult, Carolyn Magill, CEO of ...
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FDA Decision Alert
Jul 23, 2020
CDER-Approved NDA for ONGENTYS® (opicapone)
On April 24, 2020, the FDA approved Neurocrine’s ONGENTYS® (opicapone) “as an adjunctive ...
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FDA Decision Alert
Jul 23, 2020
CDER-Approved BLA for ENHERTU® (fam-trastuzumab deruxtecan-nxki)
On December 20, 2019, the FDA granted accelerated approval to Daiichi Sankyo’s ENHERTU® ...
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