Tag Archives: Unity

Bigfoot Unity Video Highlights Connected System; Celon’s Next-gen GPR40 Enters Ph2 Development

Two diabetes-related items have been observed: Bigfoot recently highlighted its Bigfoot Unity system ahead of the impending launch; and Celon Pharma announced it filed for approval to begin a Ph2 trial investigating a second-generation oral QD GPR40 agonist, referred to as CPL’280, for the treatment of T2DM. Below, FENIX provides highlights from the respective items as well as thoughts on Celon’s decision to advance its GPR40 agonist despite the previous failed efforts from competitors (e.g. Lilly, Amgen, etc.).

About The Author

Matthew Maryniak

|
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.

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Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
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.

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Purchase Blast$599.00

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Thoughts on Bigfoot’s $55M Series C and if Abbott Libre 2 FDA Approval is Imminent

Bigfoot Biomedical announced the closing of its Series C financing round for a total of $55M. With the closing of Series C, the company says it is moving closer to FDA submission of Bigfoot Unity in 2020. Recall, Bigfoot Unity is a decision support system that leverages a connected insulin pen cap and the Abbott Libre CGM. Additionally, Bigfoot’s co-founder Bryan Mazlish (view LinkedIn profile) is transitioning from president of the company to the Executive Board Director. Below, FENIX provides insights into Bigfoot’s financing, management changes, and valuation and thoughts on how the Series C closing could potentially indicate Libre 2 FDA approval is imminent.

About The Author

Matthew Maryniak

|
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.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.