Tag Archives: Beta Bionics

Novo Initiates Ph2 Cagrisema Trial in CKD and T2DM; Carmot Initiates Ph2 GLP-1/GIP RA Study in Obesity and T1DM; OptumRx Lowers Insulin Costs; Beta Bionics Gains Coverage for iLet Bionic Pancreas; Mark Estes Joins Biolinq; Belgium and Britain Ban Ozempic for Weight Loss

A series of cardiometabolic-related news items have been observed from Novo, Carmot Therapeutics, OptumRx, Beta Bionics, and Biolinq. Below, FENIX provides highlights and insights into 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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Novo Hires Private Contract Manufacturer for Wegovy Assembly and Packaging; Roche’s Tubeless Patch Pump System Receives 510(k) Clearance; Beta Bionics Introduces iLet Bionic Pancreas; NeuroBo Doses First Patient for Ph2a DA-1241 Study in NASH

Four cardiometabolic-related news items have been observed: Novo Nordisk has reportedly hired PCI Pharma Services to handle Wegovy pen assembly (view article); Roche announced it has obtained 510(k) clearance from FDA for its Accu-Chek Solo micropump system for individuals aged 2 years and older with T1DM (view press release); Beta Bionics posted a video on LinkedIn introducing the iLet Bionic Pancreas in a webinar titled, “Introduction to the iLet Webinar” (view LinkedIn post); and NeuroBo Pharmaceuticals announced the dosing of the first patient in its Ph2a trial evaluating DA-1241, a novel G-protein-coupled receptor 119 (GPR119) agonist for the treatment of NASH (view press release). Below, FENIX provides highlights and insights into 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.

Beta Bionics Secures $100M in Series D Funding; Senators Ask for Clarity on Lilly, Novo, and Sanofi’s Low-cost Insulin Products

Two cardiometabolic-related news items have been observed: Beta Bionics announced its Series D funding round has been closed at $100M (view press release); and senators have sent a letter to the CEOs of Lilly, Novo Nordisk, and Sanofi asking for greater clarification on how patients may participate in each company’s Patient Assistance Programs to obtain insulin at an affordable price (view letter; view article). 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.

FDA Clears Beta Bionics iLet ACE Pump and iLet Dosing Decision Software

FDA announced it has cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software, which form the insulin-only iLet Bionic Pancreas. A press release from Beta Bionics has not yet been observed. Recall, in May 2022, Beta Bionics presented results from its pivotal iLet Bionic Pancreas trial (view CT.gov record) at ATTD 2023 and disclosed that data from the trial was included in the comprehensive submission packaged filed with FDA (previous FENIX insight). Below, FENIX provides initial thoughts on the iLet approval.

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.

Holiday Hangover: Novo’s Wegovy/Ozempic Featured on 60 Minutes; Intercept OCA NASH NDA Refiled; Amgen Initiates Ph2 AMG 133 Obesity Trial; Steven Russell Joins Beta Bionics; Novo’s Third Cagrisema Ph3 Trial Initiated; Wegovy Pediatric Indication; Lannett Bs-Insulin Updates; Equillium and Metacrine Terminate Merger; and More

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Intercept, Amgen, Beta Bionics, Lannett, Equillium and Metacrine, MindRank, EOFlow, Medtronic, Adocia, and PeptiDream. 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 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.

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.

“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.

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.

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.

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 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.