Industry news round-up: updates from April 2023
In this latest instalment of our regular monthly column, we summarize a selection of key industry developments that have taken place over the past month.
From Industry
FDA Sentinel Initiative engages Cerner Enviza and John Snow Labs to advance the use of natural language processing in pharmacoepidemiology studies
Cerner Enviza, an Oracle company, in association with John Snow Labs, has been chosen by the FDA Sentinel Innovation Center to develop machine learning and natural language processing tools to improve the FDA’s understanding of the impact of medications in large, real-world populations using electronic health record data.
Verantos launches Pragmatic Registry product and new registry in severe asthma
Building on the Verantos Pragmatic Registry, which collects data from a diverse range of sources to generate high-validity real-world evidence and provide valuable insights into specific patient cohorts, the Asthma Pragmatic Registry, produced in collaboration with Amgen, will study people with severe asthma.
CureDuchenne and PicnicHealth announce collaboration to accelerate real-world data collection in Duchenne and Becker muscular dystrophy
Incorporation of real-world data from electronic health records through the PicnicHealth platform into the CureDuchenne Link® data-integrated biobank will accelerate research towards understanding and treatment of Duchenne and Becker muscular dystrophy.
New Truveta Language Model advances artificial intelligence unlocking of real-world electronic health record data for medical research
Truveta launches the first large-language model specifically created to empower researchers to accurately study patient care and outcomes by harnessing the potential in electronic health records.
From the Regulators
FDA releases fourth guidance document in its series on patient-focused drug development
The FDA released draft guidance on incorporating clinical outcome assessments into endpoints for regulatory decision making; the fourth and final guidance in its patient-focused drug development series.
CADTH officially advising on real-world evidence use in early drug development plans
Through the CADTH Scientific Advice Program, pharmaceutical companies can gain feedback from the agency on their plans to incorporate real-world evidence early – before development plans have been finalized.
EMA seeking feedback on the use of single-arm trials for regulatory decision making
A new reflection paper published by the European Medicines Agency outlines the agency’s current thinking on the evidence generated from single-arm trials and their use in marketing authorization applications.
