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GLP-1RA, Other

FDA Releases Framework for Use of Digital Health Technology in Clinical Trials; New Ph2 Dapiglutide Obesity Trial

Here is a brief preview of this blast: Two cardiometabolic-related news items have been observed: As part of FDA’s PDUFA VII commitments, the Agency published framework (view here) describing how it plans to address questions on the use of digital health technology (DHT) in clinical trials; and a Ph2 trial evaluating Zealand’s subcutaneous QW dapiglutide in obese participants with a BMI ≥ 30 kg/m² has been observed (DREAM; view CT.gov record). Below, FENIX provides highlights and insights into the respective news items.

About The Author

Matthew Maryniak

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President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.