A series of cardiometabolic-related news items have been observed from Pfizer, Novo Nordisk, D&D Pharmatech, Skye Bioscience, and Intarcia. Below, FENIX provides highlights and insights for the respective news items.
A series of cardiometabolic-related news items have been observed from FDA, Medtronic, 89bio, Dexcom, and Novo. Below, FENIX provides highlights and insights into the respective news items.
Three cardiometabolic-related news items have been observed: FDA posted briefing documents (view here) for its upcoming ITCA 650 adcom which is scheduled for September 21, 2023; FDA reportedly issued a Form 483 following an inspection of Novo Nordisk’s plant in Clayton, North Carolina (view article); and Abbott and WeightWatchers announced the availability of a connected app that allows PWD to access data from their Libre 2 within their WeightWatchers app (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential outcome of the ITCA 650 adcom.
Two cardiometabolic-related news items have been observed: i2o Therapeutics announced the appointment of Kurt Graves as CEO and disclosed ITCA 650 was granted an FDA adcom on September 21, 2023 (view press release); and Biomea Fusion announced the appointment of Juan Pablo Frias as CMO (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on why i2o may not actually be looking to commercialize the ITCA 650 drug/device combo.
Intarcia announced FDA accepted the ITCA-650 re-filing, nearly 2 years after it received a CRL. Additionally, Dexcom announced it received FDA clearance for a new G6 professional CGM. Below, FENIX provides thoughts and insights on the respective news items.