Tag Archives: glucagon

EMPEROR-Reduced Filed with EMA; November 2020 CHMP Agenda; Bayer Submits Finerenone to FDA and EMA; Xeris Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: the November 2020 CHMP agenda has been released and includes one notable item, EMPEROR-Reduced; Bayer announced it has filed finerenone for patients with CKD and T2DM with the FDA and EMA; and Xeris hosted its Q3 ’20 earnings call. Below, FENIX provides highlights and insights from the respective news items, including thoughts on the potentially curious EMPEROR-Reduced appearance on the November 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.

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FDA Warns Xeris for Misleading Gvoke DTC

FDA’s Office of Prescription Drug Promotion (OPDP) has issued a letter to Xeris regarding misleading advertising for its Gvoke glucagon product (view OPDP letter here; view Xeris Gvoke DTC here). Below, FENIX provides an overview of OPDP’s asserted false or misleading claims as well as implications to the ongoing Gvoke launch.

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.

Ascensia Takes Over WW Eversense CGM Distribution; Xeris and Senseonics Q2 ’20 Earnings Update; Precigen ActoBio Announces Positive Topline Results for T1DM Modulator

Four diabetes-related news items have been observed: Ascensia announced a strategic partnership with Senseonics for world-wide commercialization and distribution of the Eversense implantable CGM; Senseonics hosted its Q2 ’20 earnings call (press release), Xeris hosted its Q2 ’20 earnings call (press release), and Precigen ActoBio announced positive topline results from its Ph1b study of AG019 for the treatment of early-onset T1DM. Below, FENIX provides highlights of the respective news items, including thoughts on the curious partnership between Ascensia and Senseonics in the context of the existing partnerships between Senseonics/Roche and Ascensia/POCTech.

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.

Xeris Launches Gvoke HypoPen Autoinjector

Xeris announced the launch of its Gvoke HypoPen autoinjector (pictured below) for the treatment of severe hypoglycemia. The Gvoke website has also been updated, and it now includes a patient DTC video for HypoPen (view here). Below, FENIX provides thoughts on the Gvoke HypoPen launch as well as an analysis of the new DTC campaign in the context of Lilly’s Baqsimi (nasal glucagon) launch.

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.

Medtronic Guardian Connect CGM Android Approval; Xeris PBH Ph2 Results; Capillary Biomedical Initiates Extended-wear Infusion Set Trial

Three diabetes-related news items have been observed today: Medtronic’s Guardian Connect is now compatible with Android, Xeris announced positive topline results from ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery, and Capillary Biomedical initiated a trial for its extended-wear infusion set. Below, FENIX provides highlights and insights from the respective news items.

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.

Glucagon: Zealand Submits NDA for Dasiglucagon HypoPal Rescue Pen

Zealand Pharma announced it has submitted the dasiglucagon HypoPal Rescue Pen NDA for the treatment of severe hypoglycemia. Below, FENIX shares thoughts on the filing as well as the potential impact on the current glucagon rescue market including Lilly’s Baqsimi and Xeris’s Gvoke.

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.

Zealand Q4 ’19 Earnings Update

Zealand hosted its Q4 ’19 earnings call (press release) and provided updates to its diabetes business, including dasiglucagon and other pipeline assets. Of note, Zealand indicated that the dasiglucagon HypoPal NDA is on track for submission by the end of March 2020. Below, FENIX provides highlights and thoughts surrounding these updates.

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.

Xeris RTU Glucagon Ph2 Results for Exercise-Induced Hypoglycemia

Xeris has announced positive topline results from the in-clinic stage of its Ph2 study of ready-to-use (RTU) glucagon for the prevention of exercise-induced hypoglycemia (EIH) in patients with T1DM. Below, FENIX provides context and insights on the 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.

Zealand Q3 ’19 Earnings Update; Ph2 dual agonist trial details revealed

Zealand hosted its Q3 ’19 earnings call and provided updates to its diabetes business including dasiglucagon and its GLP-1/GCG dual agonist with Boehringer Ingelheim. Recall, Zealand recently completed the Ph3 pediatric program for the dasiglucagon HypoPal, which clears the way for NDA submission in Q1 ’20. 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.

Lilly Nasal Glucagon CHMP Opinion This Week (CHMP Agenda October 14-17)

The CHMP agenda for this week’s meeting (October 14-17) has been released, and it includes two notable items (Lilly nasal glucagon opinion and Toujeo age indication extension). Below, FENIX provides diabetes-related highlights and insights from the 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.