FDA Decision Alert
CDER-Approved NDA for KOSELUGO™ (selumetinib)
On April 10, 2020, the FDA approved AstraZeneca’s KOSELUGO™ (selumetinib) “for the ...
Blog
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 ...
Blog
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 ...
Blog
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 ...
Blog
PETs and Sharing Clinical Trial Data
Janssen’s Head of Clinical Data Standards & Transparency, Stephen Bamford, recently ...
Blog
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 ...
CDER-Approved NDA for NOURIANZ™ (istradefylline)
On August 27, 2019, the FDA approved Kyowa Kirin’s NOURIANZ™ (istradefylline), an adjunct ...
Blog
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 ...
Blog
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 ...
Blog
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, ...
Blog
Death to Privacy Shield
PETs to the Rescue in the Wake of the Privacy Shield Verdict Due to contemporary ...
FDA Decision Alert
CDER-Approved NDA for TAZVERIK™ (tazemetostat)
On January 23, 2020, the FDA approved Epizyme’s TAZVERIK™ (tazemetostat) for patients “16 ...
Blog
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 ...
Blog
PETs to Manage Emerging Privacy Risks
As the pace of technological innovation continues to grow, new risks to consumer and ...
Blog
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 ...
Article
Seven Ways to Evaluate the Utility of Synthetic Data
The article published by IEEE Security & Privacy magazine emphasizes the crucial role ...
Blog
Lessons from four recent FDA decisions in infectious disease
The use of real-world evidence (RWE) has proven pivotal to research in infectious ...
Blog
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 ...
FDA Decision Alert
CDER-Approved NDA for ONGENTYS® (opicapone)
On April 24, 2020, the FDA approved Neurocrine’s ONGENTYS® (opicapone) “as an adjunctive ...
FDA Decision Alert
CDER-Approved BLA for ENHERTU® (fam-trastuzumab deruxtecan-nxki)
On December 20, 2019, the FDA granted accelerated approval to Daiichi Sankyo’s ENHERTU® ...
FDA Decision Alert
CDER-Approved NDA for TABRECTA™ (capmatinib hydrochloride)
On May 6, 2020, the FDA approved Novartis’s TABRECTA™ (capmatinib hydrochloride) for ...
Blog
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 ...
Blog
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, ...
Blog
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, ...