Category Archives: Topics

Amgen, Novartis, and Lannett Q4 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed. Amgen (press release; slides), Novartis (press release; slides), and Lannett (press release) hosted their respective Q4 2022 earnings calls. Below, FENIX provides highlights and insights from the earnings calls.

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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Novo Nordisk Q4 ’22 Earnings Update

Novo Nordisk hosted its Q4 ’22 earnings call (press release; slides) and provided updates across its business, including Wegovy/Ozempic supply, GLP-1RA market dynamics, new QW insulin icodec data, and more. Below, FENIX provides highlights and insights from the call.

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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Pfizer Q4 ’22 Earnings; Lilly Initiates Open-Label SURPASS-SWITCH-2 Study; Fractyl Health Announces Positive Week 24 REVITA-T2Di Data; Sciwind Initiates Dosing for Ph3 Ecnoglutide Trials in China; Lifescan Announces Publication of Connected BGM RWE

A series of cardiometabolic-related news items have been observed from Pfizer, Lilly, Fractyl Health, Sciwind, and Lifescan. Below, FENIX provides highlights and insights into the respective news items including thoughts on Pfizer’s oral GLP-1RA selection and and Lilly’s strategy for conducting SURPASS-SWITCH-2.

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.

Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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.

Diabetes Research Institute Appoints Matthias von Herrath as Scientific Director; Nemaura Receives First proBEAT Purchase Order from HealthFleet

Two cardiometablic-related news items have been observed: The Diabetes Research Institute announced the appointment of its new scientific director, Matthias von Herrath (view press release; LinkedIn); and Nemaura Medical announced it has received an initial purchase order for 5,000 proBEAT subscriptions from HealthFleet Inc. (view press release). Below, FENIX provides highlights and insights including commentary on Matthias von Herrath’s potential impact on the DRI’s T1DM mission in the context of his current role as VP and Senior Medical Officer for Novo Nordisk.

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.

Abbott Q4 ’22 Earnings; Tidepool Loop Receives FDA Clearance; Lilly to Expand Incretin Manufacturing Capacity; Novo Receives Marketing Practices Complaint; AGC Biologics to Manufacture Tzield; Nemaura Reports Positive Miboko Data; J&J Q4 ’22 Earnings; and Embecta Opens New Headquarters

A series of cardiometabolic-related news items were observed from Tidepool, Lilly, Novo, Embecta, AGC Biologics, and Nemaura. Additionally, Abbott and J&J hosted Q4 ’22 earnings calls. Below, FENIX provides highlights and insights into the respective news items including commentary on why the claims against Novo’s marketing practices seem unfounded.

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.

Another Branded SGLT2i Approved by FDA; Tandem Completes AMF Medical Acquisition; January CHMP Agenda

Three cardiometabolic-related news items have been observed: TheracosBio announced FDA approved Brenzavvy (bexagliflozin), a QD 20mg oral SGLT2i, for the treatment of T2DM (view press release; label); Tandem announced it completed the acquisition of AMF Medical (view press release); and the CHMP agenda (view here) for this month’s meeting (January 23-26) has been released. Below, FENIX provides highlights and insights into the respective news items including an in-depth analysis of Brenzavvy could be another Nesina.

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

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Jardiance CKD sNDA Accepted by FDA Without Priority Review

BI/Lilly announced FDA accepted the Jardiance (empagliflozin) sNDA for the treatment of adults with CKD. According to the press release, the sNDA is based on results from the Ph3 EMPA-KIDNEY trial which demonstrated Jardiance significantly reduced the risk of kidney disease progression or CV death in adults with CKD (view CT.gov record; previous FENIX insight). Below, FENIX provides brief thoughts regarding the EMPA-KIDNEY sNDA filing and the projected PDUFA date.

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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FDA Accepts OCA NASH NDA; Palatin Initiates Ph2b DKD Trial

Two cardiometabolic-related news items have been observed: Intercept announced FDA has accepted the NDA for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to NASH (view press release); and Palatin Technologies announced that its Ph2b BREAKOUT study (CT.gov record not observed), evaluating melanocortin agonist bremelanotide in DKD, initiated enrollment in December 2022 (view press release). Below, FENIX provides highlights and insights for the respective news items, including commentary on the future of OCA’s NASH 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.

Diamyd Initiates Ph2 Trial in At-risk Individuals; Teladoc Cuts 300 Jobs; Merck to Resolve Sitagliptin Contamination Issue

Three cardiometabolic-related news items have been observed: Diamyd initiated a new Ph2 trial evaluating its vaccine in individuals at risk for T1DM (DiaPrecise; view CT.gov record); Teladoc disclosed it is laying off 300 employees which represent 6% of its workforce (view Form 8-K); and Merck has determined the source of the sitagliptin NTTP contamination issue (view article). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Diamyd’s development plan in the context of the ongoing Tzield 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.