Tag Archives: Diabetes

Tresiba Hypo Benefit Over Toujeo; Novo Q1 ’19 Earnings Update

Novo Nordisk hosted its Q1 ’19 earnings call (press release) and provided updates to its diabetes business including the recent oral semaglutide and Ozempic regulatory filings. Of note, Novo reported topline results from the Tresiba vs. Toujeo H2H trial. Below, FENIX provides highlights and insights from the call including thoughts on how the Tresiba vs. Toujeo H2H trial may impact the basal insulin 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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Insulet Q1 ’19 Earnings Update

Insulet hosted its Q1 ’19 earnings call and provided updates to its Omnipod business including the recent launch of the Omnipod Dash PDM as well as development of the Omnipod Horizon hybrid closed-loop. Below are 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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Dexcom Q1 ’19 Earnings Update

Dexcom hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, this is believed to be the first time that Dexcom distributed slides as part of an earnings release. Below, FENIX provides highlights and insights from the 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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Purchase Blast$599.00

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No Update on Sota CRL Resolution Timeline; Lexicon Q1 ’19 Earnings Update

Lexicon hosted its Q1 ’19 earnings call and briefly discussed the ongoing US regulatory situation for sotagliflozin following the March 22, 2019 CRL. Below, FENIX provides highlights and insights from the call including thoughts on the T2DM submission and approval timeline.

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 Q1 ’19 Earnings Update

Tandem hosted its Q1 ’19 earnings call and provided updates to its diabetes business including the Control IQ (hybrid closed-loop) and t:sport (with smartphone control) development programs. 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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Merck and Pfizer Q1 ’19 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’19 earnings calls. Both companies only briefly discussed their diabetes-related businesses. Below, FENIX provides highlights 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

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REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 ’19 Earnings Update

Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.

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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Victoza Pediatric Trial (ELLIPSE) Results and Regulatory Filings

Yesterday, Novo Nordisk presented results from the Victoza T2DM pediatric trial (ELLIPSE) at the Pediatric Endocrine Society/Pediatric Academic Societies annual meeting. Importantly, the results were published in the NEJM, which may be a testament to the growing attention on childhood T2DM/obesity. Additionally, Novo disclosed that it has submitted the data to US and EU regulators, although it did not specify the timing. Below, FENIX provides an overview of the ELLIPSE results – including the non-significant weight loss findings, and thoughts on the study in the context of Victoza’s impending LOE and recent settlement with Teva.

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.

Biocon CY Q1 ’19 (FY Q4 ’19) Earnings Update

Biocon hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and bs-aspart. 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.

Zynquista Approved in EU for T1DM

Sanofi and Lexicon announced they received EU marketing authorization for the commercialization of Zynquista (sotagliflozin) in T1DM (200mg and 400mg doses). Recall, on February 28, 2019, CHMP adopted a positive opinion. Zynquista is now the second SGLTi to be approved by EU regulatory authorities. On March 25, 2019, Forxiga was granted approval. Below, FENIX provides brief thoughts on the 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.

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.