Tag Archives: Diabetes

Patient Dies on t:slim X2 with Basal IQ; Tandem Denies Involvement

A report has been published on the FDA MAUDE database indicating a patient using Tandem’s t:slim X2 insulin pump with Basal IQ technology passed away on October 3, 2019. However, in an emailed statement to media outlets, Tandem said the t:slim X2 pump with Basal IQ was not involved in the patient’s death. Below, FENIX provides context and insight related to this news including potential read-through to the impending Control IQ approval.

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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Lexicon Disputes Sota CRL with FDA; Lexicon and Xeris Q3 ’19 Earnings Updates; Dexcom +30% Today

Lexicon hosted its Q3 ’19 earnings call and provided an update on the sotagliflozin T1DM regulatory situation as well as the T2DM Ph3 development program. Of note, Lexicon disclosed it has disputed the sota T1DM CRL with the Office of New Drugs, and it is awaiting a decision shortly. Additionally, Xeris released its Q3 ’19 earnings, and Dexcom stock has jumped +30% following its earnings beat. Below, FENIX provides insights on the sotagliflozin dispute including analysis of Peter Stein’s involvement in the Office of New Drugs review.

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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Dexcom and Livongo Q3 ’19 Earnings Updates

Dexcom and Livongo hosted their Q3 ’19 earnings calls and provided updates to their respective businesses. Below, FENIX provides highlights and insights 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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MannKind Q3 ’19 Earnings Update

MannKind hosted its Q3 ’19 earnings call and provided updates to its diabetes business. Of note, MannKind disclosed a new, three-pronged strategy to drive Afrezza adoption. 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.

Insulet Q3 ’19 Earnings Update

Insulet hosted its Q3 ’19 earnings call and provided updates to its Omnipod business including the ongoing launch of Omnipod Dash as well as the development of the Omnipod Horizon hybrid closed-loop system. 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.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

WaveForm CGM Receives CE Mark; Senseonics Sensor Recall

WaveForm, a subsidiary of AgaMatrix, announced it received CE Mark for its Cascade CGM system. Importantly, WaveForm also provided insight into its plans for US commercialization. Additionally, Senseonics recently initiated a voluntary recall on some of its Eversense implantable CGMs. Below, FENIX provides thoughts on the new CGM market entrant and the potential commercial outlook.

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.

Mylan and BD Q3 ’19 Earnings Updates

Mylan and Becton Dickinson hosted their respective Q3 ’19 earnings calls. Of note, Mylan provided a brief update on its insulin development program (in partnership with Biocon). Below, FENIX provides diabetes-related highlights and insights from the 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.

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 Q3 ’19 Earnings Update

Tandem Diabetes Care hosted its Q3 ’19 earnings call and provided updates to its diabetes business including the regulatory status of t:slim X2 with Control IQ (hybrid closed loop) and development status of its t:sport. 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.

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Purchase Blast$599.00

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Janssen Partners for Invokana DKD Promotion; BI/Lilly Update Alliance Terms

Janssen and Vifor Pharma announced a US commercial partnership where Vifor will promote Invokana to nephrologists based on the new CREDENCE DKD indication. Additionally, BI/Lilly disclosed plans to “modernize” their current alliance with a focus on the commercialization of Jardiance in T2DM, heart failure, and chronic kidney disease. Below, FENIX provides context and insights surrounding these announcements. Vifor to Target Nephrologists for Janssen’s Invokana Janssen announced a partnership with Vifor Pharma, a global pharmaceutical company with a focus in nephrology, iron deficiency, and cardio-renal therapies. As a part of the agreement, Vifor’s dedicated nephrology salesforce will promote Invokana to nephrologists. Janssen will……

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.

Novo Q3 ’19 London Earnings Update

Novo Nordisk hosted its post-Q3 ’19 earnings event in London. Consistent with previous quarters, the session included a brief presentation from Novo management followed by Q&A. Below, FENIX provides highlights and insights from the call including additional thoughts on Novo’s improved oral semaglutide formulation.

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.