Category Archives: Glucose Monitoring

New Dexcom Approvals; Dexcom and BD Q3 ’18 Earnings Updates

Dexcom and Becton Dickinson hosted Q3 ’18 earnings calls and provided updates to their respective businesses. Of note, Dexcom discussed two new 510(k) clearances based on the G6 iCGM regulatory pathway. Furthermore, BD said it has discontinued development of the FlowSmart infusion set in favor of other opportunities, notably the T2DM patch pump which is projected to file “in the coming months.” Below FENIX provides thoughts on how Dexcom is anticipated to leverage these new approvals for future product development and market shaping.

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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UPDATED: No Approval for Dexcom Verily G1

Yesterday, FENIX observed a J.P. Morgan analyst research publication from earlier in the week that reported Dexcom’s Verily G1 received approval based on an FDA 510(k) posting entitled “Dexcom G6 Glucose Program Continuous Glucose Monitoring System”. The research publication seemed highly credible since it was produced by the award-winning J.P. Morgan healthcare research analyst team and the FDA source was publicly available. Later, J.P. Morgan analyst Robbie Marcus admitted the incorrect reporting of the Verily G1 approval in a subsequent publication. Below are screenshots from each J.P. Morgan publication obtained by FENIX.

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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Insulet and Tandem Q3 ’18 Earnings Updates

Insulet and Tandem hosted their Q3 ’18 earnings calls and provided updates to their respective diabetes device portfolios. Of note, Insulet announced that the Omnipod Horizon automated insulin delivery (AID) system will be controlled directly by the user’s smartphone. If approved, Horizon is anticipated to be the first smartphone-controlled insulin pump. Recall, Tandem also plans to utilize smartphone control for its t:sport pump. Below are highlights from the respective earnings calls.

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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Dexcom Verily G1 Approved, But Will It Launch?

Dexcom’s Verily Gen 1 CGM has received 510(k) clearance ahead of initial projections. Dexcom has not yet issued a press release announcing the approval, but will likely discuss it during the upcoming Q3 ’18 earnings call on November 6. Below, FENIX provides thoughts on the Verily G1 CGM including whether or not Dexcom will even launch the product. Pictured below is a slide from Irl Hirsch’s 2017 talk at AACE comparing Verily G1 (top) and Verily G2 (bottom).  The continued CGM innovation back-and-forth between Dexcom and Abbott is very impressive and exciting for patients. Recall, Abbott’s 14-day Libre product and……

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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Dexcom G6 Medicare Availability in Early 2019; New Data Partnership with Validic

Dexcom announced the G6 CGM will be available to Medicare patients starting early 2019. Additionally, Dexcom has entered into an agreement with Validic to integrate Dexcom CGM data into Validic’s data connectivity platform, called Validic Inform, which streams data from in-home connected devices into HCP systems. Below, FENIX provides thoughts on G6 Medicare availability as well as reasons why the Validic partnership makes sense for Dexcom.

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 G6 Medicare Availability in Early 2019; New Data Partnership with Validic

Dexcom announced the G6 CGM will be available to Medicare patients starting early 2019. Additionally, Dexcom has entered into an agreement with Validic to integrate Dexcom CGM data into Validic’s data connectivity platform, called Validic Inform, which streams data from in-home connected devices into HCP systems. Below, FENIX provides thoughts on G6 Medicare availability as well as reasons why the Validic partnership makes sense for Dexcom.

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

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Abbott and Roche Q3 ’18 Earnings Updates

Abbott and Roche held their Q3 ’18 earnings calls and provided updates on their diabetes businesses. Of note, Abbott disclosed it has reached >1M global Libre users, which is ahead of their YE ’18 goal. No updates were provided on US launch timings for Abbott Libre 2 or Roche Solomicro pump. Below are highlights from the respective events.

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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J&J Q3 ’18 Earnings Update

J&J hosted its Q3 ’18 earnings call but only briefly discussed the Invokana franchise. Senior management did not comment on the CANVAS/R review which is anticipated this month. Recall, in July 2018, J&J announced FDA extended the CANVAS/R sNDA review by 3 months. Below, FENIX provides thoughts on the CANVAS review as well as potential read-through from Lilly’s Ph2b dual agonist results to J&J’s dual agonist, JNJ-64565111.

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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AZ’s Head of CVRM Joins Novo

Novo Nordisk announced Ludovic Helfgott (pictured below), current global head of AZ’s CV, renal, and metabolism (CVRM), is joining Novo as the Executive VP of Biopharm. According to the press release, Helfgott will join Novo effective April 3, 2019 at which point Jesper Brandgaard, current head of Novo Biopharm and well-known former CFO, will retire. Below, FENIX provides thoughts on Helfgott’s appointment and potential future impact to Novo as well as an analysis of how the Biopharm position could help Helfgott’s career.

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 With Real-Time Alerts/Alarms Approved in EU

Abbott announced it received CE Mark for the FreeStyle Libre 2, which now includes optional real-time alerts/alarms. Abbott said it will price Libre 2 at parity to the original Libre System and the company is planning an EU launch in the coming weeks. Abbott did not disclose its regulatory/commercial plans for the US; however, this remains a large market opportunity for the company and is anticipated in the coming months. Importantly, during Abbott’s EASD symposium, it was shown that the Libre 2 CE Mark approval includes the updated algorithm for overall 14-day accuracy at 9.5% MARD (US is 9.4%). Below, FENIX provides the key highlights and potential implications to the CGM market.

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.