Category Archives: Bolus Insulin

April 19-22 CHMP Agenda; EMPEROR-REDUCED Opinion?; Virta Health Raises $133M in Series E

Two cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (April 19-22, 2021) has been released and includes one notable item⁠, Jardiance HFrEF is listed under Type II Variations; and Virta Health announced it has raised $133M in a Series E equity financing round at a $2B valuation (up from $1.1B in December 2020). 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.

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Insulet Omnipod 5 Tale-of-the-tape Analysis

In March 2021, Insulet presented Omnipod 5 pivotal data at the ENDO conference in which Omnipod 5 was shown to reach 68-74% TIR with low rates of hypoglycemia (time spent 54 mg/dL of 0.17% in adults and 0.23% in pediatrics). Below, FENIX provides a tale-of-the-tape comparative analysis between Omnipod 5, Tandem’s Control IQ, and Medtronic’s 780G AHCL, as well as additional thoughts on how Omnipod 5 may effect new entrants to the 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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Purchase Blast$599.00

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

New BI/Zealand Trials in NASH and Obesity; vTv Granted BTD for TTP399; Jaguar Gene Therapy $139M Series B; CeQur $115M Series C5; Nemaura Launches BEATdiabetes App and proBEAT CGM Pilot; BioCorp/Roche Launch Mallya in France; Amarin CEO to Retire

A series of cardiometabolic-related new items have recently been observed from Boehringer Ingelheim/Zealand, vTv Therapeutics, Jaguar Gene Therapy, CeQur, Nemaura Medical, Biocorp/Roche, and Amarin. 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.

Novo Connected Pens Now Integrate with mySugr; Abbott Partners with Olympic Runner for Libre Sense Glucose Biosensor; New Non-invasive Glucose Monitoring Meter?

A series of diabetes-related news items have recently been observed: mySugr announced the integration of the Novo Nordisk NovoPen 6 and NovoPen Echo Plus connected pens into the mySugr Logbook on iOS; Abbott announced a partnership with Olympic runner, Eliud Kipchoge, and the NN Running Team to support their athletic training program through the use of Abbott’s Libre Sense Glucose Sport Biosensor; and Dongwoon Anatech is seeking US and Korean regulatory approvals for a saliva-based glucose monitor, called D-SaLife. 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.

Provention Bio Delay Appears Inevitable; Better Therapeutics To Go Public; Dexcom G6 Direct Distribution in the Netherlands; Sanofi Furthers Social Responsibility Outreach; Medtronic Commits to Three Initiatives to Address Healthcare Equity; Expanded Access to CGM and Insulin Pumps in Canada

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Better Therapeutics, Dexcom, Sanofi, Medtronic, and JDRF Canada. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how bad the teplizumab delay may really be.

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 Initiates Ph3 Sema NASH Trial; BrightInsight Secures $101M in Series C Funding; Amarin Receives EC Approval for Vazkepa CV Risk Reduction; Glytec Updates Glucommander Insulin Dosing Algorithm; Voluntis FY ’20 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for Novo Nordisk’s first Ph3 semaglutide NASH trial has been observed; BrightInsight announced it has raised $101M in Series C financing; Amarin announced EC approval of Vazkepa (icosapent ethyl) to reduce the risk of CV events in high-risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor; Glytec announced updates to its Glucommander algorithm; and Voluntis announced its FY 2020 results. 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 Medtronic/InPen MDI Basal+Bolus Advisement Connected System

A trial for a new Medtronic Guardian Connect CGM + connected insulin pen has been observed (view CT.gov record). Interestingly, the CT.gov record states the trial will use the Guardian Connect CGM, smart insulin pens, InPen Diabetes Management app, and a new device referred to as the “InPen Basal smart cap.” Below, FENIX provides an overview of the trial, insight into the potential features of the InPen Basal smart cap, and why this new product may be a reason to adopt a Medtronic solution over a Dexcom solution.

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.

Biocorp Partners to Integrate Mallya into Diabeloop AID System; vTv Initiates New TTP399 Study; Adocia and Sigilon Q4 ’20 Earnings Updates

A series of diabetes-related news items have been observed: Biocorp and Diabeloop announced a partnership to combine Biocorp’s Mallya connected pen device with Diabeloop’s insulin delivery algorithm; vTv Therapeutics announced the initiation of a study exploring the effects of TTP399 on ketone body formation during insulin withdrawal in people with T1DM; and Adocia (press release) and Sigilon (press release) announced their respective Q4 and FY ’20 earnings. 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.

Bigfoot Recieves $57M in Financing; ACC/Novo Partner for T2DM/CVD HCP Education; Amazon Care Telehealth Program Launched Nationwide

Three cardiometabolic-related news items have been observed: Bigfoot Biomedical announced it has secured combined debt and equity financing of up to $57M for the commercialization of Bigfoot Unity; ACC announced a collaboration with Novo Nordisk to educate HCPs on multidisciplinary care for people T2DM and CVD; Amazon announced the nationwide launch of its Amazon Care telemedicine program. Below, FENIX provides highlights and insight 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.

MannKind to Participate in Medicare Part D Senior Savings Model

MannKind announced it will participate in the Medicare Part D Senior Savings Model beginning in 2022 for all dosage strengths of Afrezza (inhaled uRAI). For context, the Medicare Part D Senior Savings Model provides Medicare beneficiaries with insulin co-pays capped at $35 for a 30-day supply. Below, FENIX provides thoughts on Afrezza Medicare Part D availability.

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.