Tag Archives: CGM

CGM Patent-infringement Suits: Dexcom Sues Abbott; Abbott Sues Dexcom

It has recently been observed that Dexcom filed a patent-infringement suit against Abbott for the sensors used in its Libre CGM. Subsequently, Abbott filed a suit claiming Dexcom is infringing on 12 patents. Of note, the two complaints were filed in separate courts with Dexcom filing its complaint on June 30, 2021 in US District Court for the Western District of Texas (Waco) and Abbott filing in the US District Court, District of Delaware (Wilmington) on July 1, 2021. Below, FENIX provides a summary of the filings and thoughts on the lawsuits.

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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Nemaura Q4 ’20 earnings; MET409 POC Data Published in Journal of Hepatology

Two cardiometabolic-related news items have been observed: Nemaura Medical published its CY Q4 ’20 (FY Q3 ’21) earnings update and Metacrine announced the results of the MET409 proof-of-concept study were published in the Journal of Hepatology. 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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Lifescan Redacts New CGM’s Latest Trial Record

Diabetes device company Lifescan, famous for its OneTouch portfolio of BGM products, partnered in May 2019 with Sanvita Medical to develop and commercialize a CGM system (previous FENIX insight). Below, FENIX describes how Lifescan/Sanvita redacted the details of a CT.gov record for its latest feasibility trial evaluating the Sanvita CGM system.

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.

Dexcom 2020 Investor Day Highlights

Dexcom hosted its 2020 Investor Day event and provided updates across its business, including its R&D roadmap, T2DM commercial focus, and international expansion. Interestingly, the event was patient and HCP-focused and comprised of three discussions with HCPs who use CGM in various capacities (including non-diabetes-related). Below, FENIX provides highlights from the event as well as insight into Dexcom’s ongoing transition to focus beyond T1DM and intensively managed T2DM patients.

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.

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.

FDA Accepts IND for Lilly/Dicerna Cardiometabolic Asset; Gilead/Novo Announce Ph2 PoC NASH Results; Biocorp Launches Mallya in Europe; Nemaura Q3 ’20 Earnings Update; Diabeloop Partners for AID System in Japan

A series of diabetes-related news items have been observed: Dicerna announced FDA accepted Lilly’s IND application for a novel, unknown cardiometabolic asset, LY3561774; Gilead and Novo Nordisk announced positive results from a Ph2 PoC trial evaluating Novo’s semaglutide in combination with Gilead’s investigational FXR agonist and/or its ACC inhibitor for the treatment of NASH; Biocorp announced the launch of its Mallya insulin connected cap in Europe via a partnership with cgmDiabet; Nemaura Medical announced its CY Q3 ’20 (FY Q2 ’21) earnings; and Diabeloop and Terumo Corporation announced a partnership for the joint development of an AID system and exclusive distribution rights in Japan. Below, FENIX provides highlights and insight for the respective news items including curious questions on the Dicerna target split between Lilly-Novo and semaglutide Ph3 combos in NASH.

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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Medtronic Launches InPen with Integrated Guardian Connect

Medtronic announced it has launched the InPen connected insulin pen that now integrates real-time data display with Medtronic’s Guardian Connect CGM. Recall, in August 2020, Medtronic disclosed plans to acquire Companion Medical and InPen (previous FENIX insight). Below, FENIX provides thoughts on the new InPen CGM data display integration in the context of the evolving regulatory environment as well as questions about Lilly and Novo Nordisk’s connected pen solutions.

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 Q3 ’20 Earnings Update

Senseonics hosted its Q3′ 20 earnings call (press release) and provided updates to its Eversense implantable CGM business, including the renewed US commercial launch via its partnership with Ascensia as well as an update on its LCM initiatives (180-day and 365-day implantable sensors). In conjunction with the earnings call, Senseonics announced it entered into an equity line of credit financing agreement with Energy Capital, LLC for up to $12M. Below, FENIX provides highlights and insight from the call.

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 G7 Reduced Wear Time; Q3 ’20 Earnings Update

Dexcom hosted its Q3 ’20 earnings call (press release) and provided updates to its clinical and commercial activities, including the impending filing/launch of the G7 CGM. Importantly, Dexcom disclosed G7 will now be launched with a 10-day wear time instead of 15 days, and a virtual investor event will take place on December 9, 2020. Below, FENIX provides highlights and insights from the call.

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 2020 Investor Day Highlights

Medtronic hosted its 2020 Investor Day (view slides) and provided updates across its business, including plans to reinvigorate its diabetes business. Importantly, Medtronic disclosed that just yesterday (October 13), the company completed enrollment in its next-gen Synergy CGM sensor pivotal trial. Below, FENIX provides highlights and insights from the diabetes-related portion of the event.

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