Category Archives: Glucagon

BI/Lilly’s Jardiance Receives FDA Priority Review; Novo’s Wegovy Receives Positive CHMP Opinion; Merck/Bayer Initiate New Ph3 Verquvo Study; Dario Enters Three New Commercial Agreements; Gmax Administers First in Human Dose of GMA106 in Ph1 Obesity Study; Metacrine and Zealand Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Novo Nordisk, Zealand, Merck/Bayer, Dario, Gmax Biopharma, and Metacrine. Below, FENIX provides highlights and insights for the respective news items, including an updated projection of the EMPEROR-Preserved PDUFA date.

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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MannKind and Xeris Biopharma Q3 ’21 Earnings Updates

MannKind (press release; slides) and Xeris Biopharma (press release) hosted their respective Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the events.

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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GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. Below, FENIX provides highlights and insights for 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.

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Purchase Blast$599.00

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

Medtronic Expands 630G/670G Pump Recall; Xeris Completes Acquisition of Strongbridge; DreaMed FDA Clearance for AI-based Clinical Decision Support System for T2DM; Know Labs Bio-RFID Readings Comparable to FDA-Cleared Devices

A series of cardiometabolic-related news items have been observed: Medtronic recalled 600 series insulin pumps (view FDA website); Xeris announced the closing of its acquisition of Strongbridge BioPharma; DreaMed announced FDA clearance of its AI-based clinical decision support system, called Advisor Pro, for patients with T2DM; Know Labs published a report that shows the accuracy of its non-invasive Bio-RFID technology blood glucose sensor is comparable to FDA-cleared devices (press release; view report). Below, FENIX provides further highlights and insights for the respective news items.  Medtronic expands 630G/670G pump recall Medtronic recently recalled an expanded set of its 600 series insulin pumps (630G and 670G)……

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.

Gvoke Kit Receives FDA Approval; Medtronic Q2 ’21 Earnings Update

Two diabetes news items have been observed: Xeris announced FDA approved the sNDA for Gvoke Kit (1mg/0.2 mL single-dose vial syringe kit); and Medtronic hosted its CY Q2 ’21 (FY Q1 ’22) earnings call. Below, FENIX provides highlights and insights from the Medtronic call as well as thoughts on how Xeris’s decision to develop the Gvoke Kit was likely influenced by the channel mix.

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.

Lexicon and Amarin Present Data at ESC 2021

Two cardiometabolic-related news items have been observed: Lexicon announced the presentation of additional analyses from the SOLOIST and SCORED Ph3 trials at the ESC 2021 Digital Experience; and Amarin announced the on-demand, Late Breaking Science Presentation at ESC 2021 of data from the prior MI subgroup analysis of its Vascepa/Vazkepa (icosapent ethyl) Ph3 REDUCE-IT study. Of note, the full ESC 2021 conference takes place August 27-30. Below, FENIX provides highlights and insights for 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.

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Purchase Blast$599.00

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Xeris Expanded Payor Coverage; Movano Q2 ’21 Earnings Update

Xeris announced it has reached a milestone for Gvoke payor coverage and Movano hosted its Q2 ’21 earnings update. Of note, Gvoke Medicare access has reached 91% and commercial insurance access is at 88%. Below, FENIX provides highlights and insights for 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.

New Non-invasive CGM Startup Raises $11.7M in Series B; Zealand, Mannkind, and Metacrine Q2 ’21 Earnings Updates; Integrity Applications Reverse Stock Split

A series of cardiometabolic-related news items have been observed: Hagar announced it has raised $11.7M in Series B financing for the clinical development of a non-invasive CGM; Zealand, Mannkind, and Metacrine hosted their Q2 ’21 earnings calls; and Integrity Applications announced it has implemented a 1-for-13 reverse stock split. Below, FENIX provides highlights and insights for 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.

Xeris, Amarin, Regeneron, and BD Q2 ’21 Earnings Updates

Xeris, Amarin, Regeneron, and BD hosted their respective Q2 ’21 earnings calls, Below, FENIX provides highlights and insights from the events.

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.

Ascensia Launches Patient Assistance Program for Eversense; Dario Digital Health Contract; Xeris EU Distribution Agreement for Ogluo; Medtronic Extended Wear Infusion Set 510(k) Clearance; Nimium Partnership for G3PP Activator Development; TempraMed Launches Insulin Cooler Cap

Six cardiometabolic-related news items have been observed from Ascensia, Dario, Xeris, Medtronic, Nimium Therapeutics, and TempraMed. Below, FENIX provides context and analysis for the 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.

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.