Category Archives: Topics

Medtronic Launches InPen with Integrated Guardian Connect

Medtronic announced it has launched the InPen connected insulin pen that now integrates real-time data display with Medtronic’s Guardian Connect CGM. Recall, in August 2020, Medtronic disclosed plans to acquire Companion Medical and InPen (previous FENIX insight). Below, FENIX provides thoughts on the new InPen CGM data display integration in the context of the evolving regulatory environment as well as questions about Lilly and Novo Nordisk’s connected pen solutions.

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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Senseonics Q3 ’20 Earnings Update

Senseonics hosted its Q3′ 20 earnings call (press release) and provided updates to its Eversense implantable CGM business, including the renewed US commercial launch via its partnership with Ascensia as well as an update on its LCM initiatives (180-day and 365-day implantable sensors). In conjunction with the earnings call, Senseonics announced it entered into an equity line of credit financing agreement with Energy Capital, LLC for up to $12M. Below, FENIX provides highlights and insight 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.

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.

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.

Oramed Ph3 Oral Insulin Program Initiated; Filing Timeline Unclear

A CT.gov record for Oramed’s first oral insulin (ORMD-0801) Ph3 trial has been observed. Recall, Oramed recently announced it had come to an agreement with FDA on the Ph3 program design, which will include two 26-week Ph3 trials in 1,125 adult T2DM patients (previous FENIX insight). The second Ph3 study has not yet been observed on CT.gov. Below, FENIX provides additional trial details, insight into the puzzling primary completion date, and thoughts on why the ORMD-0801 filing timeline may be different between the US and Europe.

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 to Acquire Emisphere Technologies; Mylan Q3 ’20 Earnings Update

Two diabetes-related news items have been observed: Emisphere Technologies announced it is being acquired by Novo Nordisk for $1.35B ($7.82/share) and Mylan announced its Q3 ’20 earnings update. Below, FENIX provides thoughts on Novo’s acquisition of Emisphere and potential catalysts behind the acquisition, including oral peptide delivery development beyond semaglutide.

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 ’20 Earnings Update

Tandem Diabetes Care hosted its Q3 ’20 earnings call (press release) and provided updates to its business, including the recent 510(k) filing for the t:slim X2 remote bolus feature. 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.

AZ, Provention Bio, Teva, and BD Q3 ’20 Earnings Updates

AstraZeneca (press release; slides), Provention Bio (press release), Teva (press release; slides), and Becton Dickinson (press release) hosted their respective Q3 ’20 earnings calls. Below, FENIX provides diabetes-related highlights and insights from the calls, including insight into AZ’s curious move to advance the development of its PCSK9i mAb.

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 Invests in Early-Stage Glucose-Responsive Insulin Company; Novo Presents Full STEP 3 Results; Lifescan Hires New Head of Marketing; New CymaBay GPR119 Hypo Prevention Trial

A series of diabetes-related news items have been observed: Lilly invests in Protomer Technologies, a company developing novel drug therapies, including glucose-responsive insulin (view press release); Novo presents full data from the STEP 3 semaglutide obesity study at the 2020 Obesity Week conference (view press release); Lifescan hires Lisa Rose as the new Chief Marketing Officer (view press release); and CymaBay announced its GPR119 agonist will be evaluated in a T1DM hypo prevention study at Richard Pratley’s Translational Research Institute (view press release). 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.

Insulet, Mannkind, and Lannett Q3 ’20 Earnings Updates

Insulet (press release), Mannkind (press release), and Lannett (press release) hosted their respective Q3 ’20 earnings calls. Of note, Insulet provided updates to its Omnipod 5 development plans, including the recent initiation of a T2DM feasibility study. Furthermore, following a meeting between Lannett and FDA in June 2020, Lannett said it is finalizing the trial protocol evaluating its bs-glargine in healthy volunteers. Below, FENIX provides 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.

Provention Bio Completes Teplizumab BLA Submission

Provention Bio announced it completed the teplizumab rolling BLA submission for the prevention of T1DM in at-risk patients. Recall, in August 2020, FDA granted Breakthrough Therapy Designation for the teplizumab T1DM prevention indication. Below, FENIX provides thoughts on the potential Provention Bio missed filing deadline opportunity.

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.