Skip to content

Admin

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 ...
Start Reading
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 ...
Start Reading
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, ...
Start Reading
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, ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
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, ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
Presentation
May 20, 2020

What We Learned About Data Synthesis in 2020

Start Reading
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 ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
Apr 21, 2020

CBER-Approved BLA for ZOLGENSMA (onasemnogene abeparvovec-xioi)

On May 24, 2019, the FDA approved AveXis’s ZOLGENSMA® (onasemnogene abeparvovec-xioi), ...
Start Reading
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, ...
Start Reading
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 ...
Start Reading
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 ...
Start Reading
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, ...
Start Reading
FDA Decision Alert
Apr 20, 2020

CDER-Approved NDA for EGATEN™ (triclabendazole)

On February 13, 2019, the FDA approved Novartis’ EGATEN™ (triclabendazole), which was ...
Start Reading
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), ...
Start Reading