Category Archives: Topics

Diamyd to Initiate Ph3 DIAGNODE-3 Trial in Europe; First Patient Dosed with CRISPR and ViaCyte’s VCTX210 in Ph1 Trial; Know Labs Bio-RFID Device Receives IRB Approval

A series of cardiometabolic-related news items have been observed: Diamyd Medical announced it will proceed to initiate its Ph3 T1DM vaccine trial (DIAGNODE-3) in Europe; CRISPR and ViaCyte announced they have dosed the first patient in their Ph1 VCTX210 trial; and Know Labs recently announced that it received IRB approval for a new trial of its non-invasive glucose monitor. 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.

Novo Q4 ’21 London Earnings; Sanofi and Regeneron Q4 ‘21 and FY ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’21 earnings event (see previous FENIX insight on Q4 ’21 Novo earnings from February 2); and Sanofi (press release; slides; view infographic) and Regeneron (press release; slides), hosted their respective Q4 and FY ’21 earnings calls. 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.

Lannett, Merck, Roche, and BD Q4 ‘21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lannett (press release), Merck (press release; slides), Roche (press release; slides), and BD (press release; slides) hosted their respective Q4 ’21 earnings calls. 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.

Lilly Q4 ‘21 and FY ‘21 Earnings Update

Lilly hosted its Q4 ’21 earnings call (press release; slides) and provided updates across its CVRM portfolio with a particular focus on tirzepatide. Of note, Lilly did not discuss its CVRM pipeline assets including its QW insulin (basal insulin Fc) which is scheduled to enter Ph3 this year. Below are 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.

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 Q4 and FY ’21 Earnings Update

Novartis hosted its Q4 ’21 earnings call (press release; slides) and provided brief updates to its CVRM business, including Entresto’s market performance and updates on Leqvio’s US and UK launches. Although not discussed in detail, management stated clinical trials for both iptacopan and pelacarsen remain on track. Additionally, management stated that the Sandoz strategic review remains in progress and Novartis will “hopefully come to a decision” in H2 ’22. Below are highlights 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.

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.

Novo Q4 and FY ’21 Earnings Update

Novo Nordisk hosted its Q4 and FY ’21 earnings call (press release; slides) and provided updates across its commercial and pipeline activities, including the ongoing Wegovy supply shortage and a Rybelsus launch update. Of note, Novo disclosed it has been notified of four Paragraph IV ANDA filings for generic Ozempic. Additionally, Novo reminded about its upcoming 2022 Capital Markets Day on March 3, 2022. 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.

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.

Pfizer and Ionis Discontinue Vupanorsen in Dyslipidemia; Glooko Acquires xbird; Madrigal Announces Positive Ph3 MAESTRO-NAFLD-1 Topline Results

Three cardiometabolic-related news items have been observed: Pfizer and Ionis announced they are discontinuing vupanorsen development for dyslipidemia following Ph2b topline results; Glooko announced it has acquired xbird; and Madrigal Pharmaceuticals announced positive topline results from its Ph3 MAESTRO-NAFLD-1 resmetirom study and hosted an associated webcast (listen to webcast here; slides). 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.

Insulet Omnipod 5 Receives FDA Clearance; BI/Lilly’s Jardiance HFpEF Indication Receives Positive CHMP Opinion; Provention Hosts Teplizumab BLA Resubmission Call with Investors; Lilly to Invest $1.5B in Two New Manufacturing Sites

A series of cardiometabolic-related news items have been observed: Insulet announced FDA has cleared its Omnipod 5 for T1DM patients ≥ 6 years of age; BI/Lilly announced Jardiance (empagliflozin) has received a positive CHMP opinion for extension of indication to add the treatment of patients with HFpEF; Provention hosted a call with investors to provide additional details on the teplizumab BLA resubmission as well as teplizumab LCM initiatives (listen here); and Lilly announced plans to invest over $1.5B in two new manufacturing sites in Concord, North Carolina, and Limerick, Ireland. 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.

Provention Bio to Resubmit Teplizumab BLA; Novo’s Wegovy Shortage Resolution Appears on Track; Vertex Q4 ’21 Earnings Update

Three cardiometabolic-related news items have been observed: Provention Bio announced plans to resubmit the teplizumab BLA following its Type B pre-BLA resubmission meeting with FDA; It has been reported that Novo’s Wegovy shortage may be resolved by H2 ’22 (view article); and Vertex hosted its Q4 ’21 earnings call (press release; slides). 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 3 Filed as iCGM in US; Abbott Q4 ’21 Earnings Update; FDA Warns Lilly for Misleading Trulicity Instagram Promo

Two cardiometabolic-related news items have been observed: Abbott hosted its Q4 ’21 earnings call (press release; view infographic) where it disclosed it filed the Libre 3 CGM with FDA in 2021; and FDA’s Office of Prescription Drug Promotion (OPDP) has issued a letter to Lilly regarding misleading Trulicity social media post (view OPDP letter here; view Trulicity Promo Materials here). 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.