Category Archives: Glucose Monitoring

AZ Lp(a) Licensing Deal; Novo Reaches Semaglutide Patent Settlement with Viatris; Trinity Completes Pre-Pivotal CGM Trial

Three cardiometabolic-related news items have been observed: AstraZeneca announced a licensing deal with CSPC Pharmaceutical Group for a preclinical oral Lp(a) disruptor (view press release); Novo Nordisk and Viatris have settled a lawsuit over one of Novo’s semaglutide patents (view article); and Trinity Biotech announced the completion of its EU pre-pivotal CGM trial (view press release). 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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Eversense 365 Launched in US; Kailera Launches as Obesity Biotech; Lilly Founds New $4.5B Indiana Facility

Three cardiometabolic-related news items have been observed: Ascensia Diabetes Care announced the launch of the Eversense 365 CGM in the US (view press release); Kailera Therapeutics announced its launch as a biotech with an asset in Ph3 development for the treatment of obesity (view press release; view article); and Lilly announced a $4.5B investment to create a new R&D and manufacturing facility in Lebanon, Indiana (view press release). 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.

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.

Roche Pharma Day; Rezdiffra QoL Publication; Pemvidutide Trial Enrollment Updates; NeuroBo Ph1 Obesity Readout; MannKind Afrezza Data

A series of cardiometabolic-related news items have been observed from Roche, Madrigal, Altimmune, NeuroBo, and MannKind. 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.

Eversense 365 Day CGM Receives FDA Clearance

Senseonics Holdings and Ascensia Diabetes Care announced FDA cleared the implantable Eversense 365 CGM as an iCGM system for people with T1DM and T2DM aged 18 years and older. Senseonics stated it is continuing to progress partnership discussions with various pump manufacturers looking to leverage Eversense 365 with AID systems. Ascensia plans to initiate the US launch of Eversense 365 in early Q4 2024. Below, FENIX provides brief insights into the 510(k) clearance.

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.

Abbott Launches Lingo OTC CGM in the US

Abbott announced Lingo, its OTC CGM, is now available for purchase in the US via its website (view website). The launch announcement comes shortly after Dexcom announced the launch of its own Stelo OTC CGM (previous FENIX insight). Below, FENIX has conducted an analysis of the Lingo product, website, and pricing.

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.

Dexcom Hosts Stelo Webinar; Libre 3 CGM Recall; Novartis Positive Ph3 Leqvio Trial Results; President Biden Releases Statement on AOM Prices

A series of cardiometabolic-related news items have been observed from Dexcom, Abbott, Novartis, and the Biden Administration. 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.

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.

FENIX Analysis: Pump/AID Promotional Materials Post-ADA 2024

In this final installment of the post-ADA promotional series, FENIX is evaluating pumps and AID systems from Insulet, Tandem, Medtronic, and Beta Bionics. In case you missed it, FENIX also conducted analyses of GLP-1RA (previous FENIX insight) and CGM (previous FENIX insight) promotional material from ADA 2024.

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.

Dexcom launches Stelo OTC Glucose Biosensor in the US

Dexcom announced Stelo, its OTC “Glucose Biosensor,” is now available for purchase in the US via its website (view website). Recall, in March 2024, FDA cleared Stelo for use without a prescription for T2DM patients 18 years and older who do not use insulin (previous FENIX insight). Additionally, the company is initiating its “Welcome to Stelo: Personalizing Choices, Revolutionizing Glucose Health” webinar series on August 27, 2024 (view website). Below, FENIX has conducted an analysis of the Stelo product, website, and pricing, including thoughts on Dexcom’s Stelo branding strategy and the impending launch of Abbott’s own OTC products (Lingo and Rio).

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.

Tirzepatide Three-Year Positive Pre-Diabetes and Weight-Loss Results; Medtronic CY Q2 ’24 (FY Q1 ’25) Earnings Update; Tandem iOS app update; August 19-22 CHMP Agenda

A series of cardiometabolic-related news items have been observed from Lilly, Medtronic, Tandem, and EMEA. 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.

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.

FENIX Analysis: CGM Promotional Materials Post-ADA 2024

In this second installment of the post-ADA promotional materials analysis, FENIX is evaluating CGMs from Dexcom, Abbott, and Ascensia/Senseonics. Medtronic did not have any leave-behind promotional materials for its CGM portfolio. The final installment will focus on insulin pumps/AID systems. Of note, neither Dexcom nor Abbott promoted their respective OTC CGM products (Stelo, Rio, and Lingo), although the launches are anticipated in the near future (previous FENIX insight; previous FENIX insight).

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.