Category Archives: Insulin Delivery

EASD 2023 Key Press Releases (Oct 02)

On the first day of EASD 2023, two key news items were observed from Novo Nordisk and Dexcom. The following topics are covered below (hyperlinks below are to external 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.

FDA Approves Jardiance for Adults with CKD; Abbott Completes Bigfoot Acquisition; Insulet Publishes “Market Opportunity & Impact of GLP-1s” Presentation; Lilly initiates Ph3 H2H Orforglipron vs. Semaglutide and New Ph3b Tirzepatide Max Dose Study in Obesity

A series of cardiometabolic-related news items have been observed from BI/Lilly, Abbott, Insulet, and Lilly. 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.

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.

ITCA 650 Negative Adcom Vote; Medtronic Receives CE Mark for Simplera; 89bio’s Pegozafermin in NASH Receives Breakthrough Therapy Designation; Dexcom Canada Partners with RxFood for Diabetes Management; Novo Nordisk Foundation to Establish New Cell Therapy Facility

A series of cardiometabolic-related news items have been observed from FDA, Medtronic, 89bio, Dexcom, and Novo. 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.

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 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.

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.

FENIX Analysis: Thoughts on the Abbott/Bigfoot Acquisition – A New Era for the CGM and Insulin Delivery Market?

Following Abbott’s recent announcement that it is acquiring Bigfoot (previous FENIX insight), FENIX has conducted an in-depth analysis, posing and opining on key questions like: can Dexcom stay disciplined enough to stay out of the insulin delivery market? Below, FENIX provides thoughts and potential implications across key players, including Abbott, Dexcom, Medtronic, Tandem, and Beta Bionics (among others).

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 to Acquire Bigfoot; Novo Launches Wegovy in UK; Sernova and Glyscend Appoint New CEOs; SomaLogic Expands Agreement with Novo Through 2025; Novo’s Biocorp Acquisition Updates; Diamyd to Initiate Ph3 DIAGNODE-3 in US

A series of cardiometabolic-related news items have been observed from Abbott, Novo, Sernova, Glyscend, SomaLogic, Biocorp, and Diamyd. Below, FENIX provides highlights and insights for the respective news items. Of note, FENIX will be conducting an in-depth analysis on the Abbott/Bigfoot acquisition in the coming days.

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 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.

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.

Novartis Presents Long-Term Leqvio Data; Insulet Launches Omnipod 5 in Germany; Esperion Presents Additional CLEAR Outcomes Results; Amgen Presents Olpasiran Ph2 OCEAN(a)-DOSE Extension Results

Four cardiometabolic-related news items have been observed: Novartis announced long-term Leqvio (inclisiran) data from ORION-8 were presented at the ESC 2023 conference (view press release); Insulet initiated the full market release of the Omnipod 5 AID system in Germany (view press release); Esperion presented additional bempedoic acid (BA) results from the CLEAR Outcomes study at ESC 2023 (view press release); and Amgen presented results from the off-treatment extension of the Ph2 olpasiran OCEAN(a)-DOSE study (view press release). 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 Partners with Thermo Fisher as Second Wegovy Manufacturer; Bayer Initiates New Finerenone HF Study; Welldoc’s BlueStar Receives 510(k) Clearance for CGM-mediated Dose Recommendations

Three cardiometabolic-related news items have been observed: Novo Nordisk has hired Thermo Fisher as its second contract manufacturer for Wegovy (view article); Bayer initiated a Ph3 study evaluating the safety and efficacy of finerenone in patients hospitalized with acute decompensated HF and mildly reduced or preserved LVEF (REDEFINE-HF; view CT.gov record); and Welldoc announced it received its eleventh 510(k) clearance for BlueStar to provide bolus insulin dose recommendations based on CGM data (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.

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.

Medtronic CY Q2 ’23 (FY Q1 ’24) Earnings; Lilly Initiates Retatrutide Test Device Study

Two cardiometabolic-related news items have been observed: Medtronic hosted its CY Q2 ’23 (FY Q1 ’24) earnings call (press release; slides); and Lilly initiated a Ph1 relative bioavailability study comparing SC retatrutide (LY3437943) administered by a test device vs. a reference device in healthy participants (view CT.gov record). 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.

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.