Category Archives: Topics

New Dexcom Pediatric TV DTC Campaign

A new Dexcom G6 CGM TV commercial called, “Diabetes Didn’t Come Up,” has recently been observed. Of note, this is believed to be the first time that Dexcom has created a commercial solely focused on the G6 CGM pediatric indication. Below, FENIX provides analysis of the messaging used in the TV commercial, thoughts on why the pediatric TV DTC hasn’t occurred until ~2 years after launch, and Dexcom’s peds positioning vs. Abbott Libre.

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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Sanofi Bs-Aspart Receives Positive CHMP Opinion; No Update on CREDENCE

According to the CHMP meeting highlights, Sanofi’s bs-aspart has received a positive CHMP opinion. Of note, the Invokana/Vokanamet renal protection indication (CREDENCE) was not mentioned in the meeting highlights, suggesting additional questions were asked to the sponsor. Below, FENIX provides brief thoughts on the positive CHMP opinion for Sanofi’s bs-aspart.

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.

Tandem Diabetes Care Q1 ’20 Earnings Update

Tandem Diabetes Care hosted its Q1 ’20 earnings call and provided updates to its business. Of note, Tandem disclosed that projected approvals for its remote bolus mobile app and next-gen t:sport pump have been delayed due to the COVID-19 pandemic. 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.

Roche mySugr Pro Free During COVID-19 Pandemic

Roche announced it is offering free access to mySugr Pro as part of an effort to improve remote diabetes management during the COVID-19 pandemic. According to Roche, free access to mySugr Pro will be granted through September 20, 2020. Below, FENIX provides brief thoughts on Roche’s COVID-19 response and how it appears to be a play for lead generation.

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.

CREDENCE and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 2020 CHMP agenda.

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.

AZ CVRM Q1 ’20 Earnings Update

AstraZeneca hosted its Q1 ’20 earnings call and briefly discussed its diabetes business including the recent topline data readout from DAPA-CKD, which stopped early for overwhelming efficacy. Interestingly, AZ said it does not project DAPA-CKD filing acceptance until 2021. Below, FENIX provides highlights and insights from the call, including thoughts on why the DAPA-CKD submission is later than expected.

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 Q1 ’20 Earnings Update; Dexcom G7 CGM Delayed; Eversense MRI Safety Approval in EU

Dexcom hosted its Q1 ’20 earnings call and provided updates to its diabetes business, including a disclosure that the company had a record number of new patient starts in Q1 ’20. Separately, Senseonics announced it received conditional approval for use of Eversense implantable CGMs while patients undergo MRI procedures. Below, FENIX provides highlights and insights from the call including thoughts on Dexcom’s COVID-19 response.

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.

Ertugliflozin Fails to Demonstrate CV Benefit; Merck and Pfizer Q1 ’20 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’20 earnings calls and provided updates to their diabetes businesses. Importantly, Merck disclosed that the VERTIS CV outcomes trial failed to meet superiority for CV protection. Full results from VERTIS CV are scheduled to be presented during the virtual ADA conference on June 16 at 11:15 AM ET. Below, FENIX provides highlights and insights from the respective earnings calls including thoughts on the surprising VERTIS CV results.

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.

Lexicon to Focus on Sota T1DM and Deprioritize T2DM; Lexicon Q1 ’20 Earnings Update

Lexicon hosted its Q1 ’20 earnings call and provided updates to the sotagliflozin business, including plans to focus on the sotagliflozin T1DM indication rather than T2DM. Recall, in March 2020 Lexicon announced the close out of the SCORED and SOLOIST outcomes studies due to COVID-19 as well as the low near-term prospect of finding a commercialization partner (previous FENIX insight). 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.

Efpeglenatide Officially Removed From Sanofi Pipeline; Sanofi Q1 ’20 Earnings Update

Sanofi hosted its Q1 ’20 earnings call and provided a brief update to its diabetes business, including the official removal of efpeglenatide from Sanofi’s pipeline. Unsurprisingly, the vast majority of the call was dedicated to Sanofi’s COVID-19 response and the Dupixent performance. 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.