FDA Decision Alert
CDER-Approved NDA for BLENREP (belantamab mafodotin-blmf)
On August 5, 2020, the FDA approved GlaxoSmithKline (GSK)’s BLENREP (belantamab ...
FDA Decision Alert
CDER-Approved NDA for VILTEPSO® (viltolarsen)
On August 12, 2020, the FDA approved Nippon Shinyaku’s VILTEPSO® (viltolarsen) for ...
Blog
RWE Guidance Watch: NICE updates methods for health technology evaluations
With real-world evidence (RWE) growing in influence across health care, regulatory and ...
Presentation
Synthetic Clinical Trial Data: Use Cases, Methods, and Experiences
Stephen Bamford, Head of Clinical Data Standards & Transparency; IDAR, Global ...
Blog
Data Synthesis Platform Available for the PHUSE Community
By Kayley Phillpott Posted On: December 7th, 2020
Blog
CNIL Recommends Against US Service Providers for Processing Health Data – What Does that Mean?
Organizations processing the personal data of EU citizens, and data from France in ...
Blog
RWE Guidance Watch: MHRA draft guidance on RCTs generating RWE to support regulatory decisions
With real-world evidence (RWE) growing in influence across health care, regulatory and ...
Blog
How can real-world data support opioid addiction research? Q&A with Dr. Jacob “Gus” Crothers of Groups Recover Together
The opioid epidemic is one of the greatest public health challenges this century, and its ...
Blog
ICPE research spotlight: Part III: Standard-setting research to advance the use of RWE
This year at ICPE All Access, Aetion’s scientific research is represented across 15 ...
Presentation
Optimal Synthesis of Clinical Trial Data
Khaled El Emam, SVP & GM, Replica Analytics
Publication
Evaluating Identity Disclosure Risk in Fully Synthetic Health Data
Publication
Optimizing the Synthesis of Clinical Trial Data Using Sequential Trees
Blog
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 ...
FDA Decision Alert
CDER-Approved sNDA for IBRANCE® (palbociclib)
On April 4, 2019, the FDA granted a label expansion to Pfizer’s IBRANCE® (palbociclib) ...
FDA Decision Alert
CDER-Approved NDA for AYVAKIT™ (avapritinib)
On January 9, 2020, the FDA approved Blueprint Medicines Corporation’s AYVAKIT™ ...
Blog
Can synthetic data help organizations respond to 'Schrems II'?
By Mike Hintze, Khaled El Emam Posted On: October 28th, 2020 Can synthetic data help ...
Blog
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) ...
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 ...