Category Archives: Uncategorized

EMPA-KIDNEY Stopped Early; Bayer Files FIGARO-DKD in EU; Glooko Acquires DIABNEXT; Oramed Completes Ph2 Oral Insulin NASH Enrollment; Better Therapeutics Announces BT-001 Pivotal Trial Data in T2DM

A series of cardiometabolic-related news items have been observed from BI/Lilly, Bayer, Glooko, Oramed, and Better Therapeutics. 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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Jardiance EMPULSE Trial Published; Senseonics Q4 ’21 Earnings Update; Novo Initiates Icosema COMBINE 2 Ph3 Trial; Merck’s Oral PCSK9i Enters Ph2; BI Partners with Lifebit; Intercept and Amarin Q4 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from BI/Lilly, Senseonics, Novo, Merck, BI/Lifebit, Intercept, and Amarin. 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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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lexicon Faces Another Sota Setback; Biocon to Acquire Viatris Biosimilars Business; Viatris Confirms Generic Ozempic Filing

A series of cardiometabolic-related news items have been observed: Lexicon announced it has withdrawn the sotagliflozin HF NDA; Lexicon hosted its Q4 and FY ’21 earnings call (press release); Biocon/Viatris announced Biocon will acquire the Viatris Biosimilars business; Viatris hosted an investor day and disclosed it has filed a generic Ozempic (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.

EMPEROR-Preserved Approved by FDA; Wegovy Supply Restored for Existing US Patients; Provention Bio Q4 and FY ’21 Earnings Update; Omada Closes $192M Series E

A series of cardiometabolic-related news items have been observed: FDA approved BI/Lilly’s HFpEF indication (view FDA press release; view BI/Lilly press release); Novo Nordisk’s Wegovy supply for existing US patients has been restored (view Novo Nordisk website); Provention Bio hosted its Q4 and FY ’21 earnings call (view press release); and Omada Health raised $192M in a Series E round (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.

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 FY ’21 Earnings Update; Novo Partners with Vonage for IO Customer Support; Esperion, Teladoc, and Adocia Q4 ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Insulet hosted its FY ’21 earnings call (press release); Vonage recently announced Novo Nordisk has chosen Vonage Contact Center (VCC) to support Novo’s international operations customer engagement; Esperion (press release; slides) and Teladoc (press release; slides) hosted their respective Q4 ‘21 earnings calls; and Adocia published its Q4 ’21 and FY ‘21 earnings. 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 Partners with Nintendo’s Animal Crossing Game; Beta Bionics Raises $57M in Series C Financing

Two cardiometabolic-related news items have been observed: Insulet announced it will be partnering with Nintendo for integration into the Animal Crossing: New Horizons game; and Beta Bionics announced the closing of its $57M Series C. Below, FENIX provides highlights and insights for the respective new items, including thoughts on how Insulet is likely using Animal Crossing to source new Omnipod 5 patients.

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.

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.

Jardiance HFpEF Indication Extension Up for Adoption; January 24-27 CHMP Agenda

The CHMP agenda for this month’s meeting (January 24-27) has been released, and it includes one notable item, a potential CHMP opinion for Jardiance HFpEF indication extension, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the January 2022 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.