Category Archives: Basal Insulin

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.

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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.

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Purchase Blast$599.00

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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.

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Purchase Blast$599.00

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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.

FDA Approves Lannett’s Bs-glargine IND; Biocon CY Q4 ’21 (FY Q3 ’22) Earnings Update

Two cardiometabolic-related news items have been observed: Lannett announced FDA has approved the IND application for Lannett’s bs-glargine; and Biocon hosted its Q4 ’21 (FY Q3 ’22) earnings call (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.

Arecor Initiates Ph1 Ultra-Rapid Insulin Trial in T1DM

Arecor Therapeutics announced the initiation of a Ph1 clamp study comparing its ultra-rapid insulin (AT247) to Novolog and Fiasp in T1DM patients (view CT.gov record). Recall, at EASD 2020, Arecor presented an abstract (view here) for a Ph1 study which demonstrated AT247 had a faster onset of glucose-lowering than aspart (17 vs. 50 minutes) and a greater early glucose-lowering effect compared to both aspart and faster aspart (previous FENIX insight). Below FENIX provides brief thoughts on the initiation of the Ph1 trial and Arecor’s diabetes pipeline.

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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Viatris Recalls One Batch of Non-interchangeable Semglee Prefilled Pens; Dario Hosts 2022 Investor Webinar

Two cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of one Semglee batch due to a potential missing label (view FDA website); and Dario hosted its 2022 Investor Webinar (view presentation replay) to discuss emerging digital health trends for strategic growth in 2022. 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

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JPM 2022 Day 1: DXCM, NVS, BAYRY, MDT, TDOC, VRTX; Sanofi Partners with BrightInsight; Viking Initiates GLP-1/GIP Dual Agonist Ph1 Trial

On the first day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Dexcom, Novartis, Bayer, Medtronic, Teladoc, Vertex, Pfizer, Merck, and JNJ. Additionally, two separate cardiometabolic-related news items have been observed: Sanofi announced a partnership with BrightInsight for a digital companion app (potentially for diabetes); and Viking Therapeutics announced the initiation of a Ph1 trial evaluating its novel GLP-1+GIP dual agonist (VK2735). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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.

Holiday Hangover: Novo Completes Dicerna Acquisition; FDA Approves Novartis’s Leqvio; Lexicon Submits NDA for Sotagliflozin; CMS Medicare Coverage Expansion Includes Non-adjunctive CGMs; Viatris Beats Sanofi’s Insulin-Pen Patent Invalidation Appeal; Beta Bionics iLet Bionic Pancreas Pivotal Trials Update

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Novartis, Lexicon, Medtronic, Viatris, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news 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.

Novo Hosts Wegovy Shortage Call with Investors; Lannett Files Bs-glargine IND; Provention Adds New Management; Intercept NASH Data Delayed

A series of CVRM-related news items have been observed: Novo Nordisk hosted a call with investors to provide additional information and context on the recent announcement regarding its Wegovy supply constraints (view slides); Lannett announced it has filed an IND for its bs-glargine with the pivotal trial to begin in March 2022; Provention Bio announced it has expanded its executive team; and Intercept announced its Ph3 REVERSE trial topline data readout will be delayed to Q1 ’22. Below, FENIX provides highlights and insights from the respective news 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.