Category Archives: Topics

Dexcom Q2 ’21 Earnings Update

Dexcom hosted its Q2 ’21 earnings call and provided updates to its clinical and commercial activities, including the G7 OUS launch anticipated later in 2021. 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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Semglee (Bs-glargine) Receives US Interchangeability; Sanofi Q2 ’21 Earnings Update

Two diabetes-related news items have been observed: Viatris and Biocon announced FDA approval of Semglee (bs-glargine) as the first interchangeable biosimilar insulin product under the 351(k) regulatory pathway; and Sanofi hosted its Q2 ’21 earnings call and provided a brief update to its diabetes business. 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.

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Purchase Blast$599.00

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

AZ Q2 ’21 Earnings Updates

AstraZeneca hosted its Q2 ’21 earnings call, and once again, much of the prepared remarks and Q&A focused on the company’s COVID-19 vaccine development and oncology portfolio. 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.

Lifescan and Noom Expand Partnership; Supersapiens Adds Zisser and Ketchell to Leadership Team; Teladoc, Pfizer, and Teva Q2 ’21 Earnings Update

A series of cardiometabolic-related new items have recently been observed: Lifescan and Noom announced an expanded partnership focused on Noom’s Diabetes Support Program; Supersapiens announced the addition of Howard Zisser and Robby Ketchell to the company’s executive team; Teladoc (press release; slides), Pfizer (press release; slides), and Teva (press release; slides) hosted their respective Q2 ’21 earnings calls. 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.

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.

AZ and Regeneron Collaborate on Obesity Treatment Development

AstraZeneca and Regeneron announced a collaboration for the research, development, and commercialization of small molecule compounds against the GPR75 gene to treat obesity and related comorbidities. For context, genetic mutations in GPR75 have been linked to patients having a lower BMI and experiencing a 54% lower risk of obesity than those without the mutation. According to the press release, AZ and Regeneron will evenly split the research and development costs as well as any future profits.

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.

Finerenone Label and Website Analysis

Bayer recently announced 10mg and 20mg finerenone, branded as “Kerendia,” received FDA approval. The approval of finerenone is based on the positive results of the FIDELIO-DKD study which demonstrated an 18% RRR in the primary composite endpoint. Below, FENIX has conducted a Kerendia label and website analysis.

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.

Bydureon BCise US Pediatric Approval; Biocon FY Q1 ’22 (CY Q2 ’21) Earnings Update; Afrezza Pediatric Ph3 Trial Observed

A series of diabetes-related news items have recently been observed: AZ announced FDA approval of Bydureon BCise for patients 10-17 years of age with T2DM; Biocon hosted its FY Q1 ’22 (CY Q2 ’21) earnings call; and a CT.gov record has been observed for MannKind’s first Afrezza Ph3 pediatric study, called INHALE-1. 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.

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.

Abbott, Roche, and Adocia Q2 ’21 Earnings Updates

Abbott (press release; view infographic) and Roche (press release; slides) hosted their Q2 ’21 earnings calls and provided updates to their respective diabetes businesses and Adocia provided its Q2 ’21 financial update. 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.

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.

Leqvio PDUFA Date Disclosed; Verquvo EC approval; Ph1b Trial to Delay the Onset or Progression of T1DM Meets Primary Endpoint; Novartis and J&J Q2 ’21 Earnings Updates

Four cardiometabolic-related news items have been observed: Novartis hosted its Q2 ’21 earnings call (press release; slides) and disclosed the Leqvio (inclisiran) PDUFA date is on January 1, 2022; Merck and Bayer received EC approval of vericiguat, branded as “Verquvo,” for the treatment of symptomatic chronic HF (Merck press release here and Bayer press release here); IM Therapeutics announced positive topline results from a Ph1b study evaluating IMT-002 in adults with T1DM and the HLA-DQ8 gene; and Johnson & Johnson hosted its Q2 ’21 earnings call (press release; slides). 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.

Ascensia Launches Patient Assistance Program for Eversense; Dario Digital Health Contract; Xeris EU Distribution Agreement for Ogluo; Medtronic Extended Wear Infusion Set 510(k) Clearance; Nimium Partnership for G3PP Activator Development; TempraMed Launches Insulin Cooler Cap

Six cardiometabolic-related news items have been observed from Ascensia, Dario, Xeris, Medtronic, Nimium Therapeutics, and TempraMed. Below, FENIX provides context and analysis for the announcements.

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.