Category Archives: Glucose Monitoring

Insulet Receives 510(k) Clearance for O5 iPhone App; Viking Completes Enrollment for Ph2 GLP-1/GIP RA Studyin Obesity

Two cardiometabolic-related news items have been observed: Insulet announced the Omnipod 5 iPhone app received FDA 510(k) clearance (view press release); and Viking Therapeutics announced enrollment completion for its Ph2 study of VK2735 (GLP-1/GIP RA) in patients with obesity (view press release). Below, FENIX provides highlights and insights into 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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Abbott Q3 ’23 Earnings; Tzield PROTECT Data at ISPAD 2023; Viking GLP-1/GIP RA Ph1 Data at ObesityWeek

Three cardiometabolic-related news items have been observed: Abbott hosted its Q3 ‘23 earnings call and disclosed there are now 5M Libre users globally (press release; infographic); Sanofi presented data from the PROTECT Ph3 trial evaluating teplizumab in newly diagnosed T1DM (view press release); and Viking Therapeutics announced new results from the Ph1 SAD/MAD clinical trial evaluating its GLP-1/GIP RA, VK2735 (view press release). Below, FENIX provides highlights and insights into 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

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

Novo Raises 2023 Guidance; Glucotrack’s Implantable CGM Preclinical Results

Two cardiometabolic-related news items have been observed: Novo Nordisk announced it raised its 2023 sales and operating profit guidance (view press release); and Glucotrack announced results from the most recent preclinical testing study for its implantable CGM (view press release). Below, FENIX provides highlights and insights into 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.

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.

Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into 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.

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.

EASD Key Press Releases (Oct 5)

On the fourth day of EASD 2023, seven key news items were observed from BI/Zealand, Novo Nordisk, Fractyl, Sernova, Dexcom, and Biomea. The following topics are covered below (hyperlinks to external 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.

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.

EASD 2023 Key Press Releases (Oct 02)

On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external 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.

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.

Rockley Photonics Progresses Non-Invasive, Optical Blood Glucose Monitoring; Intercept to be Acquired by Alfasigma; EMA to Discuss GLP-1RA-Associated Aspiration Risks; Kallyope Initiates Ph2 trial of Oral Obesity and T2DM Treatment

Four cardiometabolic-related news items have been observed: Rockley Photonics announced it is continuing to make progress on non-invasive glucose sensing with its wearable silicon photonics-based sensor (view press release); Intercept announced it has entered a definitive agreement to be acquired by Alfasigma (view press release); EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will reportedly be discussing aspiration-related risks associated with GLP-1RAs in its September 2023 meeting (view article); and Kallyope announced it initiated a Ph2 trial evaluating K-757 and K-833, oral nutrient receptor agonists, for the treatment of obesity and T2DM (view press release). Below, FENIX provides highlights and insights into 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.

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.

Novo Partners with Valo Health for CVD and Evotec for Cardiometabolic Drug Discovery Accelerator; Zucara Doses First Patient in Ph2a ZONE Trial; Merck Initiates Efinopegdutide Study in Hepatic Impairment; Senseonics Completes Adult Arm of ENHANCE Pivotal Study; NeuroBo Posts Ph2 DA-1241 Trial in NASH to CT.gov

A series of cardiometabolic-related news items have been observed from Novo, Zucara, Merck, and NeuroBo. Below, FENIX provides highlights and insights into 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.

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.

ITCA 650 Negative Adcom Vote; Medtronic Receives CE Mark for Simplera; 89bio’s Pegozafermin in NASH Receives Breakthrough Therapy Designation; Dexcom Canada Partners with RxFood for Diabetes Management; Novo Nordisk Foundation to Establish New Cell Therapy Facility

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.

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.

ITCA 650 Faces Uphill Battle as FDA Releases Adcom Briefing Docs; Novo Receives Form 483 Observations; Abbott and WeightWatchers Launch Connected App Experience

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.

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.