Category Archives: Topics

Tandem Hosts 2021 R&D Webinar; FDA Accepts IND for G&L’s Novel GLP-1 Analogue; BD Announces Name of Diabetes Spin Off Company

Three cardiometabolic-related news items have been observed: Tandem hosted its 2021 R&D webinar (view here; slides) and provided an in-depth review of the company’s product pipeline, including the t:slim X3, t:sport (Mobi), and a future patch pump; Gan & Lee announced FDA accepted its IND application for a novel GLP-1 analog, referred to as GZR18; and Becton Dickinson announced that its diabetes spinoff business company will be named “embecta [pronounced em-BECK-tah]. 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.

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Abbott Sues Dexcom Over Breached Settlement Agreement; Bigfoot Clinical Hub Improvements; Hygieia Raises $17M in Series B; ViaCyte’s Ph1/2 VC-02 Preliminary Results Published; Dario Announces New Employer and Provider Contracts

A series of cardiometabolic-related news items have been observed: Abbott recently filed a lawsuit stating Dexcom allegedly violated a 2014 settlement agreement and asked the court to declare that Abbott doesn’t infringe its patents (view article); Bigfoot Biomedical issued a press release highlighting the success of its Bigfoot Unity Diabetes Management Program and Clinic Hub; Hygieia announced it has raised $17M in Series B financing for its AI-driven d-Nav insulin dose automation technology; ViaCyte announced preliminary results of its ongoing, first-in-human Ph1/2 VC-02 trial were published in Cell Stem Cell and Cell Reports Medicine; and Dario announced new employer and provider contracts. 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.

Novartis Hosts 2021 R&D Webinar

Novartis hosted its 2021 R&D webinar (view here; slides) and provided a company-wide outlook through 2030 with regard to its cardio-renal pipeline, management focused on Leqvio (PCSK9i for ASCVD), pelacarsen (Lp(a) for ASCVD), and iptacopan (Factor B Complement for nephrology and hematology). There was only brief commentary regarding Entresto’s continued growth. Below, FENIX provides highlights and insights from the Novartis R&D event.

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.

Sciwind Biosciences Acquires Worldwide Rights to Sanofi’s GIP Receptor Agonists; Diamyd Pauses Initiation of Ph3 DIAGNODE-3 Trial; AMF Medical’s Sigi Patch Pump Receives Breakthrough Device Designation; FDA Authorizes Sample Size Expansion for Fractyl Health’s Revitalize-1 Pivotal Trial

A series of cardiometabolic-related news items have been observed: Sciwind Biosciences announced it has entered into a WW exclusive licensing agreement to develop and commercialize Sanofi’s GIP receptor agonists; Diamyd Medical announced it has paused the initiation of its Ph3 DIAGNODE-3 trial due to potential contamination in the manufacturing process of the Diamyd diabetes vaccine; AMF Medical announced that its insulin patch pump for closed-loop integration (Sigi) has received Breakthrough Device Designation; and Fractyl Health announced FDA authorized the expansion of its Revitalize-1 pivotal clinical study (formerly REVITA-T2Di) sample size from 288 to 420. 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.

Libre 2 Android App Cleared in US; CytoDyn Reports Positive Leronlimab NASH Data; Kadimastem Raises $3.2 to Support T1DM Cell Therapy Development; Integrity Applications Changes Name to GlucoTrack, Inc.

A series of cardiometabolic-related news items have been observed: It has been observed that the Libre 2 Android app recently received FDA clearance (view FDA 510(k) database); CytoDyn announced positive data from the leronlimab open-label NASH trial; Kadimastem announced it has raised $3.2M from ILEX Medical in a private financing round to support Kadimastem’s T1DM and ALS cell therapy development programs; and Integrity Applications announced it has changed its name to GlucoTrack, Inc. 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.

Happy Thanksgiving from CVRM! Coming Soon in December…

Happy Thanksgiving from the CVRM team!

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 Q3 ’21 (FY Q2 ’22) Earnings Update; HAGAR’s GWave Receives Breakthrough Device Designation; Oramed Randomizes 75% of Patients in Oral Insulin Trial; Beyond Type 1 Launches Web Platform in Arabic

A series of cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’21 (FY Q2 ’22) earnings call (press release; slides); HAGAR announced that its non-invasive CGM (GWave) has received Breakthrough Device Designation; Oramed announced it has enrolled and randomized 75% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Beyond Type 1 announced it has launched its web platform in Arabic. 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.

Intarcia Files Notice of Opportunity for a Hearing; Provention Bio Advances popPK Model for Teplizumab; Zealand Announces Dapiglutide Topline Results

Three cardiometabolic-related news items have been observed: It has been reported that Intarcia Therapeutics has filed for a Notice of Opportunity for a Hearing with FDA for ITCA-650 (link to WSJ article); Provention Bio announced topline results from preliminary analysis of popPK model; and Zealand announced topline results for Ph1b trial with GLP1-GLP2 dual receptor agonist (dapiglutide). 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.

Alnylam Hosts 2021 R&D Webinar

Alnylam hosted its 2021 R&D webinar (view here; slides) and discussed its 2022 product and pipeline goals, including CVRM assets. Below, FENIX provides highlights and insights from the Alnylam R&D event.

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.

Teladoc Hosts 2021 Investor Day; Better Therapeutics Pivotal BT-001 Trial for T2DM Completes Enrollment; Dario Announces New Employer Contracts

Three cardiometabolic-related news items have been observed: Teladoc Health hosted its 2021 Investor Day (view here; slides); Better Therapeutics announced the pivotal study evaluating the safety and efficacy of BT-001 for the treatment of T2DM has completed enrollment; and Dario announced it has entered into contracts with a national transportation employer for diabetes, and a regional employer for behavioral health. 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.