Sciwind Biosciences Acquires Worldwide Rights to Sanofi’s GIP Receptor Agonists; Diamyd Pauses Initiation of Ph3 DIAGNODE-3 Trial; AMF Medical’s Sigi Patch Pump Receives Breakthrough Device Designation; FDA Authorizes Sample Size Expansion for Fractyl Health’s Revitalize-1 Pivotal Trial
A series of cardiometabolic-related news items have been observed: Sciwind Biosciences announced it has entered into a WW exclusive licensing agreement to develop and commercialize Sanofi’s GIP receptor agonists; Diamyd Medical announced it has paused the initiation of its Ph3 DIAGNODE-3 trial due to potential contamination in the manufacturing process of the Diamyd diabetes vaccine; AMF Medical announced that its insulin patch pump for closed-loop integration (Sigi) has received Breakthrough Device Designation; and Fractyl Health announced FDA authorized the expansion of its Revitalize-1 pivotal clinical study (formerly REVITA-T2Di) sample size from 288 to 420. Below, FENIX provides highlights and insights for the respective new items.
About The Author
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.
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