Tag Archives: Libre 3

Lilly Invests $1.6B in Indiana Manufacturing; Dexcom and Abbott Highlight Medicare CGM Coverage Expansion; Tandem Announces Positive Control-IQ Meta-Analysis

Three cardiometabolic-related news items have been observed: Lilly announced that it will invest an additional $1.6B and add another 200 jobs to its new manufacturing sites within LEAP Innovation Park in Boone County, Indiana (view press release); Dexcom (view press release) and Abbott (view press release) separately issued statements regarding CMS’s decision to expand Medicare coverage for T2DM, including certain non-insulin-using individuals; and Tandem Diabetes announced that Diabetes Technology & Therapeutics published a meta-analysis of three Control-IQ AID trials (view press release; publication). 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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Lilly Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (view CT.gov record). 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.

CLEAR Outcomes Full Results; Abbott Libre 2 and 3 AID Clearance; New Lexicon HF Awareness Campaign; Merck to Advance Oral PCSK9i to Ph3; Amarin Announces Non-Sarissa Board Departures; BI/Lilly COORDINATE-Diabetes Results

A series of cardiometabolic-related news items have been observed from Esperion, Abbott, Lexicon, Merck, and BI/Lilly. 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.

Esperion Launches Website Featuring CLEAR Outcomes; Abbott Receives 510(k) Approval for APIs; Novartis Initiates Ph3 Inclisiran Primary Prevention Trial; Nemaura and Viatris Q4 ’22 Earnings Updates

Five cardiometabolic-related news items have been observed: Esperion announced it has launched a new website (esperionscience.com) featuring information about CLEAR Outcomes (view press release); Abbott received FDA 510(k) approval to add APIs to the FreeStyle Libre 2 and 3 CGM systems (view 510(k) decision letter); Novartis has initiated a Ph3 trial evaluating inclisiran vs. placebo in a primary prevention cohort (VICTORIAN-1 PREVENT; view CT.gov record); Nemaura Medical published its CY Q4 ‘22 (FY Q3 ‘23) business update (press release); and Viatris hosted its Q4 ’22 earnings call (press release; slides). Below, FENIX provides highlights and insights from 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.

Medtronic InPen App Recall; Libre 3 + Ypsomed AID Available in Germany; Altimmune Positive Pemvidutide NAFLD Data; Embecta CY Q3 ’22 Earnings Update; Alnylam Submits ALN-KHK CTA for T2DM; Biocorp Receives EU Medical Device Certification

A series of cardiometabolic-related news items have been observed from Medtronic, Abbott, Altimmune, Embecta, Alnylam, and Biocorp. Below, FENIX provides highlights and insight on the respective news items, including thoughts on the Medtronic recall and how the positive Altimmune NAFLD data may not be enough.

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.

Libre 2 Appears to Remain in US Soft Launch; When will Broad Launch Commence?

A series of events and observations have been made that suggest the Libre 2 US commercialization remains in a soft launch; however, a broad launch of the Libre 2 system may be in the near term. Below, FENIX provides analysis on the Libre 2 soft launch, potential insight into Abbott’s rationale to simultaneously market Libre 14-day and Libre 2, and thoughts on whether Abbott would minimize Libre 2 promotional efforts if Libre 3 US approval is around the corner.

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 Q3 ’20 Earnings Update; Novo Licenses Antibody Engineering Tech From Chugai

Two diabetes-related news items have been observed: Abbott hosted its Q3 ’20 earnings call (press release) and Chugai licensed its antibody engineering technology to Novo Nordisk (press release). Below, FENIX provides highlights from the respective news items as well as insight into how Novo may leverage Chugai’s antibody technology.

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.

First Libre 3 Clinical Study Initiated

A CT.gov record has been observed for what is believed to be the first Abbott Libre 3 clinical trial. Abbott publicly disclosed the existence of Libre 3 during its Q1 ’19 earnings call (previous FENIX insight). Recall, the Libre 2 CGM was recently approved in the US, but its use with integrated systems is limited due to Vitamin C interference (previous FENIX insight). There is no mention of Vitamin C in the Libre 3 CT.gov record. Below, FENIX provides an overview of the new Libre 3 study as well as potential insight into the timing of its initiation in the context of the Libre 2 US label restrictions.

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.