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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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Blog
Aug 19, 2020

Death to Privacy Shield

PETs to the Rescue in the Wake of the Privacy Shield Verdict Due to contemporary ...
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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 7, 2020

PETs to Manage Emerging Privacy Risks

As the pace of technological innovation continues to grow, new risks to consumer and ...
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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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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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