Category Archives: Glucose Monitoring

Novartis Discontinues LIK066 in obesity; Novartis and Abbott Q2 ’18 Earnings Updates

Novartis and Abbott both held their respective earnings calls today and provided updates to their respective commercial and pipeline products. Of note, Novartis disclosed it has discontinued development of LIK066 (dual SGLT1/2 inhibitor) for the treatment of obesity. Abbott believes it will be able to reach 1 million global Libre users by YE ’18. Below are highlights from the respective Q2 ’18 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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J&J Q2 ’18 Earnings Update

J&J hosted its Q2 ’18 earnings call and provided brief updates on its diabetes business. Importantly, senior management did not make any comments regarding the early stopping of the CREDENCE study or the delay in the CANVAS/R CV indication. Below are highlights from the Q2 2018 J&J earnings 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.

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Thoughts on Beta Bionics and Implications to Stable Glucagon, Senseonics, and Fiasp

Beta Bionics has initiated (press release) their home-use clinical trial (CT.gov record)of an insulin-only iLet AP system. Additionally, Ed Damiano, Beta Bionic’s CEO, presented at the Friends For Life conference and provided an update on the iLet commercial device. Below, FENIX provides analysis of the iLet study as well as implications to the glucagon 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.

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Purchase Blast$599.00

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Thoughts on New Dexcom G6 T2DM Basal-Only Study (MOBILE)

A new trial (MOBILE) evaluating Dexcom’s G6 CGM vs. SMBG in 207 T2DM patients has been observed. With this trial, Dexcom appears to be moving beyond “intensive insulin-using T2DM” patients and into “basal-only,” which is a considerably larger market opportunity. Below, FENIX provides further details into the study design as well as thoughts on how Dexcom may utilize these results for expanding the G6 CGM eligible population.

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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Senseonics to integrate with Glooko

Senseonics has announced a global partnership with Glooko, allowing for integration of the Eversense implantable CGM with Glooko’s diabetes data management platform. Under the partnership, Eversense data can be synced to the Glooko platform directly from the Senseonics cloud, allowing both users and HCPs to access historical glucose and related data. Below, FENIX analyzes the value of this partnership for Senseonics.

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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Thoughts on New Sanofi/Verily Connected Care Pre-filled T2DM Pump Partnership

With Sanofi and Verily’s recent Sensile Medical partnership for a connected pre-filled patch pump (Sensile website), FENIX has conducted an analysis of Sanofi’s connected care strategy with market, manufacturing, and payer implications. Below, FENIX provides insight into the diabetes connected care landscape in the context of the large insulin manufacturers (Sanofi, Novo, and Lilly).

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.

“Smart CGM is a new category” – Medtronic ADA 2018 investor event summary

In conjunction with the ADA 2018 congress, Medtronic hosted an investor event (slide presentation) and the diabetes senior management team provided additional insights into their evolving business philosophy beyond the June 5 investor day. Below, FENIX provides a summary of the investor event, which had a large amount of news, as well as analysis behind Medtronic’s deliberate strategic choice to compete near-term in CGM features and solutions vs. hardware convenience.

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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Devices/Apps ADA ’18 Key Data Press Releases (June 23)

As a follow-up to our drug analysis of 14 press releases, FENIX has provided context and analysis for 7 device and app-related 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.

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Purchase Blast$599.00

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Tandem’s t:slim X2 pump approved with Basal-IQ; Medtronic 670G approved for ages 7-13

Tandem announced FDA approval of its t:slim X2 insulin pump with Basal-IQ technology which utilizes a predictive low-glucose suspend (PLGS) feature, curiously with Dexcom G6 rather than G5 as previously communicated. Additionally, FDA has expanded the approval of the Medtronic MiniMed 670G to include children aged 7 to 13 with T1DM.

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 Eversense CGM approved in the US; sPMA for insulin-dosing claim to follow

Senseonics has announced approval of Eversense, their implantable CGM, in the US and held an investor call. Of note, Senseonics did not mention anything regarding the updated components discussed during the adcom (sensor end cap and insertion tool); however, it was approved with the smaller gen 2 transmitter. Below, FENIX has conducted an analysis of the approval, safety labeling, and market implications.

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.