Tag Archives: Insulet

Insulet Expands DASH Availability in Europe; Nemaura In-Licenses Healthimation Diabetes App; Dario Enters Distribution Agreement with HMC; Arecor uRAI to be Presented Tomorrow; Adocia to Host Business Review; EASD 2020 Key Press Releases (Sept 21)

On the first day of EASD, five key press releases were observed from Insulet, Nemaura Medical, DarioHealth, Arecor, and Adocia. Below FENIX provides insights and context from each respective announcement.

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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Apple Cites T1DM Omnipod Patient Story at Tuesday Event; Jardiance Post-MI Trial (EMPACT-MI) Receives FDA FTD; Adocia Topline Results from M1Pram Ph1b Trial Extension; Welldoc/UMD Employs AI to Identify Digital Health Habits; Oramed’s Positive Diabetes Market Survey Results; Diamyd Receives $13.9M Towards Companion Medical Shares

A series of diabetes-related news items have been observed: Apple featured a T1DM patient story during the Apple Watch portion of its event; BI/Lilly announced Jardiance has received Fast Track designation for its EMPACT-MI study; Adocia announced positive topline results from its Ph1b M1Pram extension study in PWT1D; Welldoc and the University of Maryland’s Center for Health Information and Decision System (CHIDS) announced findings from a user engagement analysis; Oramed announced results from a diabetes market survey; and Diamyd received $13.9M from its divestment in Companion Medical. 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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Purchase Blast$599.00

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

Mylan Filed for Glargine Interchangeability; Insulet, Mylan, and BD Q2 ’20 Earnings Updates

Mylan (press release; slides), Insulet (press release), and Becton Dickinson (press release; slides) hosted their respective Q2 ’20 earnings calls. Of note, Mylan disclosed it has submitted “all necessary documentation to seek biosimilar interchangeability [for Semglee]” as well as a BLA for its bs-aspart with FDA. Below, FENIX provides highlights and insights from the respective earnings 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.

Roche Sues Insulet for Omnipod Royalties

According to court documents (view here), Roche has filed a lawsuit vs. Insulet in the US District Court of Delaware, seeking royalties due to claimed infringement on a Roche patent (7,931,613). The ‘613 patent, titled “Module For A Computer Interface” was issued on April 26, 2011 and relates to the Accu-Chek Combo system. Of note, Roche’s complaint does not request Insulet to remove its products from the market. Below, FENIX provides brief thoughts on the suit.

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 Q1 ’20 Earnings Update

Insulet hosted its Q1 ’20 earnings call and provided updates to its diabetes business including the impact of COVID-19 and timing of the Omnipod Horizon launch. Of note, Insulet has filed the updated Horizon algorithm after the company discovered a software anomaly in early March 2020, leading to the trial being put on hold. 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.

Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. 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.

Omnipod Horizon Pivotal Trial Delayed

Insulet announced it will be pausing Omnipod Horizon pivotal trial due to a recently-discovered “software anomaly.” The updated software is expected to be available by the end of April 2020; however, the Omnipod Horizon launch timeline has been pushed back to early 2021. Below, FENIX provides potential insights on the delay as well as implications to other insulin delivery algorithm developers.

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 Q4 ’19 Earnings Update

Insulet hosted its Q4 ’19 earnings call (press release) and provided updates to its Omnipod business including the Omnipod Horizon closed-loop system. Of note, Insulet disclosed that it has completed enrollment in the Omnipod Horizon pivotal trial and indicated its intentions to deprioritize concentrated insulin development. Below are 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.

Insulet Partners with Dexcom and Abbott; ATTD 2020 Key Press Releases (Feb 19)

With the start of the ATTD 2020 conference, a series of diabetes technology-related press releases have been observed including partnerships between Insulet/Dexcom, Insulet/Abbott, Dexcom/Dreamed, and Biocorp/iSage Rx. Additionally, Dario Health presented new data at ATTD 2020 for its connected BGM platform, and Diabeloop initiated a trial to support 510(k) clearance of its automated insulin delivery algorithm. 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 Omnipod DASH Software Bug; No Injuries Reported

Insulet announced it has initiated a “voluntary Medical Device Correction” for all Omnipod DASH devices. According to Insulet, on some rare occasions when the bolus calculator is left open or an alarm interrupts a bolus calculation, DASH may suggest incorrect boluses based on older glucose values. Below, FENIX provides thoughts on the Omnipod DASH issue in the context of Medtronic’s recent 630G/670G pump recall as well as potential readthrough to Tandem, Bigfoot, and Beta Bionics.

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.