Category Archives: Basal Insulin

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.

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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.

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Purchase Blast$599.00

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

Novo STEP 4 Sema Obesity Results @ ENDO 2021; Oramed Second Oral Insulin Ph3 Trial Update; Dexcom Promotes Jereme Sylvain to CFO; vTv Granted New Patent for TTP399

A series of diabetes-related news items have been observed: Novo Nordisk presented results from the STEP 4 semaglutide 2.4mg obesity trial at the ENDO 2021 conference (view press release); Oramed announced it has screened the first patients in its second oral insulin Ph3 trial; Dexcom has promoted Jereme Sylvain to CFO, allowing Quentin Blackford to take over Steve Pacelli’s responsibilities for strategy and corporate development (view press release); and vTv announced the USPTO issued patent 10,952,993 protecting methods of treatment using TTP399, a novel GKA. Below, FENIX provides highlights and insights from the respective news items, including updated perspective on Oramed’s potential regulatory 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.

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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.

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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.

Glooko Raises $30M Series D; AZ and BrightInsight Launch Digital Platform; Oramed Randomizes 25% of Patients in Ph3 Oral Insulin Trial

Three diabetes-related news items have been observed: Glooko announced it raised $30M in a Series D funding round; BrightInsight announced the launch of AstraZeneca’s AMAZE Disease Management Platform for chronic diseases, including diabetes, heart failure, and CKD; and Oramed announced it has enrolled and randomized 25% of the 675 patients planned for its Ph3 oral insulin trial in T2DM. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Glooko’s Series D being a down round.

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.

Lannett Receives FDA Feedback for Bs-glargine; Adocia Initiates Ph2 M1Pram Trial; Vertex Receives Fast Track Designation for VX-880 in T1DM; Welldoc Hires New CMO; Intercept CFO to Depart

A series of diabetes-related news items has been observed: Lannett announced it received FDA feedback regarding its biosimilar insulin glargine Ph3 program; Adocia announced the initiation of a Ph2 study evaluating M1Pram (pramlintide+insulin FRC) vs. Humalog in patients with T1DM; Vertex announced FDA granted Fast Track Designation to VX-880 for the treatment of T1DM; Welldoc announced the hiring of Marina Dorotheo as CMO; and Intercept announced the resignation of CFO, Sandip Kapadia. 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.

Viatris Generic Rybelsus in the Pipeline; Viatris 2021 Investor Day

Viatris hosted its first Investor Day (view slides), and the company provided updates across its diabetes generics and biosimilars portfolio. Importantly, the company disclosed plans to develop a generic version of Novo Nordisk’s Rybelsus (oral semaglutide). Below, FENIX provides brief highlights from the Investor Day as well as insight into challenges and questions of generic Rybelsus development.

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.

Lilly Partners with Welldoc for Connected Pen App

Lilly and Welldoc announced a partnership to integrate Welldoc’s diabetes software solutions with Lilly’s connected insulin delivery ecosystem. According to the press release, the companies will create a new version of Welldoc’s BlueStar app that integrates dosing data from “several of Lilly’s connected insulin pen solutions.” For context, the BlueStar app (view website) includes insulin titration support, a bolus calculator, and personalized health coaching. Below, FENIX provides an overview of the Lilly/Welldoc partnership, including thoughts on how the partnership supports FENIX’s hypothesis that Lilly’s connected pen development is further behind than initially thought.

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.

DAPA-CKD filed with EMA; February 22-25 CHMP Agenda; G&L Partners with IDF

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (February 22-25, 2021) has been released, and it includes one notable item: DAPA-CKD appears for the first time; and Gan & Lee announced a new partnership with IDF. 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.