Category Archives: Other

Abbott Announces Libre 3 Clearance; Lexicon Resubmits Sota NDA; Dexcom Denies Insulet Acquisition Speculation

Three cardiometabolic-related news items have been observed: Abbott issued a press release addressing the recent FDA clearance of its Freestyle Libre 3 (view press release); Lexicon announced it has resubmitted the sota HF NDA; and Dexcom issued a press release responding to recent media and market speculation that the company was in the process of acquiring Insulet (view press release). 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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Bigfoot Hires Matt Rainville as CCO; Medtronic CY Q1 ’22 (FY Q4 ’22) Earnings Update; Pfizer’s NASH Combo Receives Fast Track Designation; ReShape and OpenLoop Collaboration for Virtual Weight Loss Coaching Program

A series of cardiometabolic-related news items have been observed: Bigfoot announced it has appointed Matt Rainville (view LinkedIn) as CCO; Medtronic hosted its CY Q1 ’22 (FY Q4 ’22) earnings call (press release; slides); Pfizer announced FDA granted Fast Track designation to Pfizer’s ervogastat+clesacostat combination therapy for NASH; and ReShape LifeSciences and OpenLoop announced a collaboration for a nationwide launch of reshapecare. 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.

Bayer Presents New Finerenone Analysis; Lilly to Invest $2.1B in Additional Manufacturing Capacity; Oramed Granted Combination Therapy Patent for Oral GLP-1+Insulin

Three cardiometabolic-related news items have been observed: During the ESC’s 2022 HF Congress, Bayer presented late-breaking data from an exploratory FIDELITY post hoc analysis; Lilly announced plans to invest $2.1B in new Indiana manufacturing sites; and Oramed recently announced it has been granted a US patent for its oral GLP-1RA+insulin combination therapy in T2DM. 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.

Mounjaro WAC Pricing Analysis; Lilly @ UBS 2022

Late last week, Lilly disclosed Mounjaro will be offered at $974.33 WAC across all available doses. Additionally, during Lilly’s fireside chat at UBS 2022 (view replay), Mike Mason, Lilly’s SVP and President of Diabetes briefly commented on Lilly’s pricing rationale for tirzepatide (discussed below). As a follow-up to FENIX’s Mounjaro label and website analysis (previous FENIX insight), FENIX has conducted a Mounjaro pricing analysis, including insight into why Lilly may opt to create a second brand for the tirzepatide obesity indication.

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.

Provention Hosts Teplizumab Commercial Launch Investor Event; Lifescan Initiates New RWE Study; Diamyd Enrolls First Patient in Ph3 T1DM Vaccine Trial; Dario Announces New Employer and Provider Contracts; MySugarWatch Expands DTC Marketing Campaign; Adocia Q1 ’22 Earnings Update

A series of cardiometabolic-related news items have been observed from Provention Bio, Lifescan, Diamyd, Dario, Nemaura, and Adocia. 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.

Mounjaro (tirzepatide) Label and Website Analysis

Late last week, FDA approved Lilly’s tirzepatide, branded as Mounjaro (mown-JAHR-OH), for the treatment of adults with T2DM (view label; previous FENIX insight). Below, FENIX has conducted a label and website analysis, including potential insight into the Mounjaro launch.

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.

MannKind to Acquire Zealand’s V-Go T2DM Patch Pump; Sernova/Evotec Collaboration for Beta Cell Therapy; AACE Updates NAFLD Guidelines

Three cardiometabolic-related news items have been observed: MannKind announced plans to acquire Zealand’s V-Go insulin delivery device; Sernova and Evotec announced an exclusive global strategic partnership to develop an implantable iPSC-based beta cell replacement therapy and hosted an associated investor call (listen to webcast here); and AACE has updated its NAFLD practice guidelines which favor GLP-1RAs (view guidelines). 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.

May 16-19 CHMP Agenda; Glyscend Therapeutics Completes Ph1 GLY-200 Trial in T2DM

Two cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (May 16-19) has been released; and Glyscend Therapeutics announced the completion of its single and multiple ascending dose (SAD/MAD) Ph1 GLY-200 trial in T2DM. 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.

Movano and Embecta Q1 ’22 Earnings Updates; Hygieia Launches d-Nav Clinical Partnership Program in Michigan

Three cardiometabolic-related news items have been observed: Movano (press release) and Embecta (press release; slides) hosted their respective Q1 ‘22 earnings calls; and Hygieia announced the launch of its d-Nav Clinical Partnership Program for endocrinology practices treating patients with T2DM. 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.

Tirzepatide Approved in US as “Mounjaro”

FDA announced it has approved Lilly’s tirzepatide as “Mounjaro” for the treatment of adults with T2DM. Recall, Lilly filed the tirzepatide T2DM BLA with a PRV in October 2021 (previous FENIX insight) which allowed for a 6-month review. Tirzepatide remains under review in the EU. The label has not yet been observed at the time of this publication. FENIX will conduct a full label analysis of tirzepatide in the coming days once the label is available.

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.