Tag Archives: Beta Bionics

Novo Nordisk and Ventus Therapeutics Partner for NASH; Intercept’s OCA Misses Primary Endpoint in Ph3 REVERSE Trial; Beta Bionics Publishes Pivotal Trial Results in NEJM; Diamyd Completes Dosing Patients in DIAGNODE-B Booster Trial

Four cardiometabolic-related news items have been observed: Ventus Therapeutics announced it entered into an exclusive WW license agreement with Novo Nordisk to develop and commercialize its NLRP3 inhibitor portfolio in multiple TAs including NASH; Intercept announced the Ph3 REVERSE trial of obeticholic acid (OCA) in compensated cirrhosis due to NASH failed to meet its primary endpoint; Beta Bionics published results from its insulin-only bionic pancreas pivotal trial in the New England Journal of Medicine (view publication); and Diamyd announced it dosed the last patient with an additional booster of the Diamyd vaccine in its DIAGNODE-B trial (view CT.gov record). Below, FENIX provides highlights and insights for the respective new 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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“Mass” Layoff at Beta Bionics?; Novo Initiates Ph3 Ozempic + Lower-Dose Glargine Trial; Novartis to Spin Off Sandoz; Lannett and Adocia CY Q2 ’22 Earnings Updates; Hygieia Appoints New CEO

A series of cardiometabolic-related updates have been observed: Beta Bionics has reportedly laid off an unknown number of employees (view LinkedIn post); a Novo-sponsored Ph3 trial evaluating Ozempic and lower-dose insulin glargine has been observed (SUSTAIN OPTIMIZE; view CT.gov record); Novartis announced plans to spin off Sandoz (press release); Lannett (press release) and Adocia (press release) released their Q2 ’22 earnings; and Hygieia announced the appointment of a new CEO. Below, FENIX provides context and insight on 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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Sean Saint Takes Over as Beta Bionics CEO

Beta Bionics announced it has appointed Sean Saint (view LinkedIn; pictured below) as the company’s new CEO and board member. Saint will be replacing Martha Goldberg Aronson (view LinkedIn) who will remain on the Beta Bionics Board of Directors after serving as the interim CEO since February 2022. Prior to Beta Bionics, Saint founded and led Companion Medical, which was acquired by Medtronic in August 2020 (previous FENIX insight). More recently, in April 2022, Saint co-founded a new diabetes insulin delivery company called Luna Diabetes in collaboration with other diabetes device veterans including Jon Brilliant (view LinkedIn), John Sjolund (view LinkedIn), and Jasper Benke (view LinkedIn; previous FENIX insight). Below, FENIX provides brief thoughts on Saint’s appointment as Beta Bionics’s new CEO and what it means for the company’s future as it prepares for the launch of its insulin-only iLet bionic pancreas (previous FENIX insight).

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.

Thoughts after ATTD and ADA 2022

Now that we’re on the other side of ADA 2022, FENIX provides provocative thoughts below on various items in the cardiometabolic space. Included are thoughts about Lilly, Novo, Sanofi, Dexcom, Abbott, Medtronic, 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.

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Purchase Blast$599.00

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Beta Bionics Insulin-only iLet Pivotal Trial Results @ ATTD 2022; Vertex’s Ph1/2 VX-880 Trial Placed on Clinical Hold

Two cardiometabolic-related news items have recently been observed: Beta Bionics presented results from its insulin-only bionic pancreas pivotal trial at ATTD 2022 (press release); and Vertex issued a press release detailing updates to its Ph1/2 VX-880 trial, including that FDA has placed a clinical hold on the study (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.

Beta Bionics Management Changes Ahead of Insulin-only iLet Bionic Pancreas Launch; Glooko Partners with Johns Hopkins

Two cardiometabolic-related news items have been observed: Beta Bionics recently announced executive leadership and board transitions ahead of launching its insulin-only iLet bionic pancreas; and Glooko announced a collaboration with Johns Hopkins HealthCare Solutions to helps patients with their diabetes management. Below, FENIX provides highlights and insights for the respective new 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 Partners with Nintendo’s Animal Crossing Game; Beta Bionics Raises $57M in Series C Financing

Two cardiometabolic-related news items have been observed: Insulet announced it will be partnering with Nintendo for integration into the Animal Crossing: New Horizons game; and Beta Bionics announced the closing of its $57M Series C. Below, FENIX provides highlights and insights for the respective new items, including thoughts on how Insulet is likely using Animal Crossing to source new Omnipod 5 patients.

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.

Holiday Hangover: Novo Completes Dicerna Acquisition; FDA Approves Novartis’s Leqvio; Lexicon Submits NDA for Sotagliflozin; CMS Medicare Coverage Expansion Includes Non-adjunctive CGMs; Viatris Beats Sanofi’s Insulin-Pen Patent Invalidation Appeal; Beta Bionics iLet Bionic Pancreas Pivotal Trials Update

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Novartis, Lexicon, Medtronic, Viatris, and Beta Bionics. 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.

ADA 2021 Key Press Releases (June 27)

On day three of ADA 2021, five cardiometabolic-related news items were observed from Novo Nordisk, Lilly, Insulet, Beta Bionics, and Tandem. 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.

Beta Bionics’s iLet Breakthrough Designation; Roche Receives CE Mark for Novel BG Test; Glooko Receives ISO 13485 Certification

FENIX has observed several announcements across diabetes technology players. First, Beta Bionics has received breakthrough device designation for the iLet Bionic Pancreas System from the FDA. Note, Beta Bionics is the only manufacturer to receive this designation for 3 system configurations (insulin-only as well as dual-hormone and glucagon-only using Zealand’s dasiglucagon), as no other companies have disclosed configurations beyond insulin-only. Additionally, Roche announced it has received CE Mark for the Accu-Chek SugarView, a meter-free BG monitoring system. Further, Glooko has received ISO 13485 certification, meeting requirements for safety and quality of their system. Below, FENIX provides context and insights on these 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.