Category Archives: Glucose Monitoring

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.

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ITCA 650 Faces Uphill Battle as FDA Releases Adcom Briefing Docs; Novo Receives Form 483 Observations; Abbott and WeightWatchers Launch Connected App Experience

Three cardiometabolic-related news items have been observed: FDA posted briefing documents (view here) for its upcoming ITCA 650 adcom which is scheduled for September 21, 2023; FDA reportedly issued a Form 483 following an inspection of Novo Nordisk’s plant in Clayton, North Carolina (view article); and Abbott and WeightWatchers announced the availability of a connected app that allows PWD to access data from their Libre 2 within their WeightWatchers app (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential outcome of the ITCA 650 adcom.

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.

Madrigal Receives Priority Review for Resmetirom NASH NDA; Adipo Therapeutics Appoints Keith Johns as CSO; Novo Nordisk Conducts a Two-for-One Stock Split; Nemaura Announces Interim Miboko Study Results

Four cardiometabolic-related news items have been observed: Madrigal Pharmaceuticals announced FDA accepted the company’s resmetirom NDA for the treatment of adult patients with NASH with liver fibrosis and granted a priority review (view press release); Keith Johns announced he is joining Adipo Therapeutics as the Chief Strategy Officer to continue to advance Adipo as a potential breakthrough treatment for T2DM and obesity (view LinkedIn post); Novo Nordisk announced its Board of Directors approved a split of the trading units of the Novo Nordisk B shares listed on Nasdaq Copenhagen and of the American Depositary Receipts (ADRs) listed on New York Stock Stock Exchange (NYSE) in a two-for-one ratio (view press release); and Nemaura Medical announced interim results from its Miboko metabolic health program with NHS in the UK (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.

Entera Bio to Collaborate with OPKO Biologics for Obesity; Dexcom Launches Dexcom ONE in France; Altimmune Completes Ph2 Obesity Trial Dosing; Vertex Acquires Novel GPCR-targeted Program

Four cardiometabolic-related news items have been observed: Entera Bio and OPKO Biologics entered into a research collaboration agreement for OPKO’s long-acting GLP-2 peptide and certain oxyntomodulin (OXM) analogs (view press release); Dexcom announced Dexcom ONE has been launched in France (with reimbursement) for patients two years of age and older with T1DM and T2DM, who are undergoing intensive insulin therapy (view press release); Altimmune announced the completion of dosing in its 48-week Ph2 MOMENTUM trial, evaluating the safety and efficacy of pemvidutide in patients with obesity or overweight (view press release); and Septerna announced it signed a definitive asset purchase agreement with Vertex for an undisclosed discovery-stage GPCR program (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.

September CHMP Agenda; Nemaura Announces Interim 24-Hour Wear sugarBEAT Results; Madrigal Appoints Bill Sibold as CEO

Three cardiometabolic-related news items have been observed: The CHMP agenda (view here) for this month’s meeting (September 11-14) has been released; Nemaura Medical announced interim results from a 100-patient study across 4 cohorts of 25 (view press release); and Madrigal Pharmaceuticals announced Bill Sibold as the successor to Paul Friedman as CEO (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.

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.