Tag Archives: Ascensia/Senseonics

Eversense CGM Receives iCGM Designation

Senseonics announced its implantable Eversense CGM has been granted iCGM designation by FDA. Following the iCGM designation, the company stated it plans to advance partnership discussions with various pump manufacturers for AID integration. Below, FENIX provides brief insight into the potential impact of receiving the iCGM designation for Senseonics/Eversense.

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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Senseonics, Akero, Amarin Q4 ’23 Earnings; Viking Commences $550M Public Offering; Pfizer and Regor Initiate Oral GLP-1RA Studies; Virta Published GLP-1RA Discontinuation Results

A series of cardiometabolic-related news items have been observed from Senseonics, Akero, Viking, Pfizer, Regor Therapeutics, Virta Health, and Amarin. 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.

Novo to Discontinue Levemir; Lilly Initiates Ph2 GLP-1/GCG RA Trial; Zealand, Lexicon, Senseonics, Xeris, and Bayer Q3 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Lilly, Zealand, Lexicon, Senseonics, Xeris, and Bayer. 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.

Senseonics and Dario Q2 ‘23 Earnings

Two cardiometabolic-related news items have been observed: Senseonics (view press release) and Dario (view press release) hosted their respective Q2 ‘23 earnings. 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.

Lilly Poised to Own the Obesity Market; ADA 2023 Key Press Releases (June 26)

On the last day of ADA 2023, nine cardiometabolic-related news items were observed from Lilly, Pfizer, Fractyl Health, Zealand Pharma, Vertex, Sernova, Senseonics, Dario, and GSK. Below, FENIX provides context and analysis for the announcements.

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.

Lilly Initiates Ph3 Retatrutide Obesity Program; UnitedHealthcare Expands Coverage to Eversense E3 CGM

Two cardiometabolic-related news items have been observed: Lilly initiated the first trial in the Ph3 retatrutide obesity program (TRIUMPH-3; view CT.gov record); and Senseonics announced UnitedHealthcare will cover the Eversense E3 CGM starting July 1, 2023, for T1DM and insulin-requiring T2DM patients. Below, FENIX provides highlights of the respective news items, including insight into the potential retatrutide Ph3 TRIUMPH program and Lilly’s strategy for an obesity CVOT.  

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.

BI and Zealand Announce Positive Ph2 BI 456906 Obesity Results; Senseonics and MannKind Q1 ’23 Earnings; Sanofi Study Demonstrates Benefit of Dario; MyFitnessPal and Google Health CGM Integration; Diamyd’s Remygen Fails To Support Durable Treatment Effect

A series of cardiometabolic-related news items have been observed from BI and Zealand, Dario and Sanofi, MyFitnessPal and Google Health, and Diamyd Medical. Additionally, Senseonics and MannKind hosted their respective Q1 ’23 earnings calls. 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.

Senseonics Q4 ’22 Earnings and CGM Investor Event; OrsoBio Doses First Patient in Ph2 TLC-3595 Trial for Insulin Resistance

Two cardiometabolic-related news items have been observed: Senseonics hosted a CGM virtual investor event last week which coincided with the company’s Q4 2022 earnings release (press release; slides); and OrsoBio announced that the first patient has been dosed in its Ph2a clinical trial evaluating the safety and insulin sensitizing effects of TLC-3595, a selective ACC2 inhibitor (view press release; CT.gov record). Below, FENIX provides highlights and insights from the news items, including thoughts on Senseonics’s pipeline in the context of its previous commercial struggles and the evolving CGM landscape.

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.

EMPA-KIDNEY Demonstrates 28% RRR @ ASN 2022; Sernova to Expand Ph1/2 Patient Cohort; Creative Medical Cell Therapy IND Granted FDA Clearance; Senseonics/Ascensia Collaborate with NPG to Expand Eversense CGM Access; Amgen Q3 ’22 Earnings Update

A series of cardiometabolic-related news items have been observed: Lilly/BI and Oxford jointly announced that the EMPA-KIDNEY trial demonstrated a 28% RRR in the primary composite endpoint, with results simultaneously published in NEJM (view publication); Sernova announced it received FDA authorization to expand enrollment for its Ph1/2 Cell Pouch trial (view CT.gov record); Creative Medical announced FDA accepted its IND application for its AlloStem cell therapy system; Senseonics and Ascensia announced a collaboration with The Nurse Practitioner Group (NPG) to provide in-office and at-home Eversense procedures; and Amgen hosted its Q3 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective new 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.