Category Archives: Glucose Monitoring

Novo to Acquire Biocorp; Akero Announces Ph2b SYMMETRY Results; Enterin Initiates Ph1a ENT-03 Study

Novo to Acquire Biocorp; Akero Announces Ph2b SYMMETRY Results; Enterin Initiates Ph1a ENT-03 Study

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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Lilly Initiates Ph3 Retatrutide Obesity Program; UnitedHealthcare Expands Coverage to Eversense E3 CGM

Two cardiometabolic-related news items have been observed: Lilly initiated the first trial in the Ph3 retatrutide obesity program (TRIUMPH-3; view CT.gov record); and Senseonics announced UnitedHealthcare will cover the Eversense E3 CGM starting July 1, 2023, for T1DM and insulin-requiring T2DM patients. Below, FENIX provides highlights of the respective news items, including insight into the potential retatrutide Ph3 TRIUMPH program and Lilly’s strategy for an obesity CVOT.  

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.

Updated FDA Draft Guidance for Diabetes Trials; Esperion Files CLEAR Outcomes sNDAs; Positive Glyscend Topline Ph2a GLY-200 Results and ADA 2023 Presentations; Pharming Sells PRV to Novartis

A series of cardiometabolic-related news items have been observed from FDA, Esperion, Glyscend, and Pharming/Novartis. 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.

Akebia Rejected Again by FDA; Know Labs Announces Positive Bio-RFID Results; Lilly and XtalPi Collaborate for AI Drug Discovery; Structure Doses First Patient in Ph2a Oral GLP-1RA Study

Four cardiometabolic-related new items have been observed: Akebia Therapeutics announced it received a written response from FDA denying the vadadustat CRL (view press release); Know Labs published a report showing the accuracy of its non-invasive Bio-RFID blood glucose reading used in combination with algorithm optimization using a light gradient-boosting machine (lightGBM) machine learning model (view press release; view report); XtalPi announced a collaboration with Lilly, using AI plus robotics to uncover first-in-class therapeutics for undisclosed targets (view press release); and Structure Therapeutics announced the first patient has been dosed in its Ph2a study evaluating GSBR-1290 in overweight/obese patients with and without T2DM (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 Q1 ‘23 (FY Q4 ‘23) earnings update

Medtronic hosted its CY Q1 ‘23 (FY Q4 ‘23) earnings call (press release; slides) and provided brief updates to its diabetes business. Importantly, Medtronic disclosed plans to acquire EOFlow Co. Ltd. for its patch pump technology (view press release). Additionally, Medtronic will be hosting an investor event at ADA 2023 where it will provide more details on its diabetes portfolio and pipeline. Below, FENIX provides highlights and insights from the earnings call, including thoughts on how the EOFlow acquisition fits into Medtronic’s strategy to turn around its struggling diabetes business.

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BI and Zealand Announce Positive Ph2 BI 456906 Obesity Results; Senseonics and MannKind Q1 ’23 Earnings; Sanofi Study Demonstrates Benefit of Dario; MyFitnessPal and Google Health CGM Integration; Diamyd’s Remygen Fails To Support Durable Treatment Effect

A series of cardiometabolic-related news items have been observed from BI and Zealand, Dario and Sanofi, MyFitnessPal and Google Health, and Diamyd Medical. Additionally, Senseonics and MannKind hosted their respective Q1 ’23 earnings calls. 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

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AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings updates. 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.

Dexcom, Amgen, and Merck Q1 ’23 Earnings; JDRF and Humacyte Collaborate on Insulin-Producing Biovascular Pancreas for T1DM

Four cardiometabolic-related news items have been observed: Dexcom (press release; slides), Amgen (press release; slides), and Merck (press release; slides) hosted their respective Q1 ’23 earnings calls; and JDRF and Humacyte announced a collaboration to advance the development of Humacyte’s Biovascular Pancreas (BVP) product candidate for the treatment of T1DM (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.

Lilly to Divest Baqsimi to Amphastar; Medtronic 780G+GS4 FDA Approval; April CHMP Agenda

Three cardiometabolic-related news items have been observed: Lilly announced it entered into a definitive agreement with Amphastar Pharmaceuticals to divest Baqsimi worldwide rights (view press release); Medtronic’s MiniMed 780G system with the Guardian Sensor 4 (GS4) has received FDA approval (view press release); and the CHMP agenda (view here) for this month’s meeting (April 24-26) has been released. Below, FENIX provides highlights and insights into the respective news items including insight into Lilly’s potential strategy behind the Baqsimi move.

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 ’23 Earnings; Eversense 365-Day Sensor Inserted Into First Pediatric Patient; Esperion Partners With Currax for Nexletol/Nexlizet Promotion; Zucara ZT-01 Ph2 T1DM IND Cleared

Four cardiometabolic-related news items have been observed: Abbott hosted its Q1 ’23 earnings call (view press release; infographic); Senseonics announced the Eversense 365-day sensor has been inserted into the first pediatric patient as part of the ENHANCE clinical trial (view press release); Esperion announced a co-promotion agreement with Currax for Nexletol and Nexlizet (view press release); and Zucara Therapeutics announced FDA has cleared the ZT-01 IND application for the prevention of nocturnal hypoglycemia in patients with T1DM (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.