Category Archives: Topics

Viatris’ Semglee Preferred on Express Scripts NPF; DreaMed’s Advisor Pro Launched in Leading Children’s Hospital; MiniMed 780G & Guardian 3 TIR In Pediatrics Comparable to Adults; Abbott and Roche Q3 ’21 Earnings Updates; vTv Therapeutics Hires New President and CEO; Adhera Adds Target Indications for MLR-1023

A series of cardiometabolic-related news items have been observed from Viatris, DreaMed, Medtronic, Abbott, Roche, vTv Therapeutics, and Adhera Therapeutics. 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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Lilly’s Ph3 Tirzepatide SURPASS-4 Results Published in Lancet; FDA Pre-Submission for rt-Glucose Salivary Test; Ultrahuman Hires Chief Business Officer; J&J Q3 ‘21 Earnings Update

A series of cardiometabolic-related news items have been observed: Lilly announced results of its Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk were published in The Lancet (view publication); IQ Group Global announced that GBS Inc has filed a pre-submission package with FDA for its salivary glucose test; Ultrahuman announced Bhuvan Srinivasan will join the company as its first chief business officer; and J&J hosted its Q3 ’21 earnings call (press release; slides). 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.

Medtronic to Acquire Triple Jump?; Esperion to Reduce Workforce by 40%; Diamyd’s Ph3 T1DM Vaccine Trial Initiated; Vertex Announces Positive Results From Ph1/2 VX-880 Trial

A series of cardiometabolic-related news items have been observed: It has been reported that Medtronic is in advanced discussions to acquire a patch pump company (view article); Esperion announced plans to align operational and expense structure, including a workforce reduction of 40%; Diamyd announced the initiation of its Ph3 T1DM Vaccine trial (DIAGNODE-3) in Europe; and Vertex announced positive results from the first patient in Ph1/2 VX-880 trial for patients with T1DM. 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.

Forxiga Pediatric Indication and Generic Sitagliptin Receive Positive CHMP Opinions

Two cardiometabolic-related news items have been observed: AstraZeneca’s Forxiga received a positive CHMP opinion to include treatment of children aged 10 years and older with T2DM; and generic sitagliptin received a positive CHMP opinion. 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.

G&L Bs-glargine Completes Ph3; Adocia’s BC Lispro Cleared for Pivotal Ph3 in China; Dario Signs National Digital Behavioral Health Contract

A series of cardiometabolic-related news items have been observed: Gan & Lee announced the conclusion of its two Ph3 bs-glargine studies; Adocia announced that its partner, Tonghua Dongbao, received clearance to initiate a Ph3 trial for uRAI BioChaperone Lispro in China; and Dario announced it was selected as the digital behavioral health provider for an undisclosed US national health plan. 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.

Dexcom Launches Garmin Connect IQ Apps for Dexcom G6; Dexcom Expands TIR Educational Campaign in UK

Two diabetes-related news items have been observed, both from Dexcom: Dexcom announced that US patients with diabetes can now view Dexcom G6 CGM data on their Garmin smartwatch and cycling computer; Dexcom announced the expansion of its TIR Initiative in the UK. Below, FENIX provides further 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.

vTv Therapeutics Announces Positive Results from TTP399 Mechanistic Trial; Non-Invasive CGM From Innovation Zed Advances

Two diabetes-related news items have been observed: vTv Therapeutics announced positive results of TTP399 mechanistic study in patients with T1DM; Innovation Zed announced research advancements for its non-invasive CGM project. Below, FENIX provides further 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.

Jardiance HFpEF Indication Filed in EU; Generic Sitagliptin (EMEA/H/C/005741) CHMP Decision?; October 11-14 CHMP Agenda

The CHMP agenda for this month (October 11-14) has been released, and it includes two notable items, BI/Lilly has filed the Jardiance HFpEF indication and an opinion for generic sitagliptin (EMEA/H/C/005741) is up for adoption. Below, FENIX provides highlights and insights from the October 2021 CHMP agenda.

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.

New NovoPen 6 Connected Pen Trial in T1DM (CONNECT 1); Lilly-sponsored Treprostinil/Sodium Citrate Infusion Site Pain Trial in T1DM; Dario Partners with New Employer Group; Ascensia Launches “This is Diabetes” Competition

A series of diabetes-related news items have been observed: Novo has initiated a NovoPen 6 connected pen observational trial in T1DM (CONNECT 1; view CT.gov record); Lilly has initiated a treprostinil/sodium citrate infusion site pain trial in T1DM (view CT.gov record); Dario announced a new agreement with a US global employer; Ascensia announced launch of “This is Diabetes” competition. Below, FENIX provides further 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.

Medtronic Expands 630G/670G Pump Recall; Xeris Completes Acquisition of Strongbridge; DreaMed FDA Clearance for AI-based Clinical Decision Support System for T2DM; Know Labs Bio-RFID Readings Comparable to FDA-Cleared Devices

A series of cardiometabolic-related news items have been observed: Medtronic recalled 600 series insulin pumps (view FDA website); Xeris announced the closing of its acquisition of Strongbridge BioPharma; DreaMed announced FDA clearance of its AI-based clinical decision support system, called Advisor Pro, for patients with T2DM; Know Labs published a report that shows the accuracy of its non-invasive Bio-RFID technology blood glucose sensor is comparable to FDA-cleared devices (press release; view report). Below, FENIX provides further highlights and insights for the respective news items.  Medtronic expands 630G/670G pump recall Medtronic recently recalled an expanded set of its 600 series insulin pumps (630G and 670G)……

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.