Category Archives: Topics

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.

Removal of Forxiga T1DM Indication? Generic Sitagliptin Up for Opinion?; July 19-22 CHMP Agenda

The CHMP agenda for this month (July 19-22) has been released, and it includes two notable items, Forxiga T1DM indication removal and generic sitagliptin, as well as several other cardiometabolic-related entries. 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.

GSK Releases Positive Dapro Topline Results Day After Negative Roxa Adcom; Dexcom Cleared for Third-party Integration; New Medtronic Klue Trial Observed

A series of cardiometabolic-related news items have recently been observed: GSK announced positive topline results from five Ph3 studies in the ASCEND program evaluating daprodustat in patients with anemia due to CKD; Dexcom announced FDA has cleared Dexcom Partner Web APIs which now allows third-party integration with other digital health apps and devices; and a new Medtronic closed-loop trial leveraging its Klue acquisition has been observed. 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.

Roxa Adcom Votes Overwhelmingly Against Approval in NDD (1-13) and DD (2-12)

Today, FDA held an advisory committee meeting to discuss the proposed roxadustat indication for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. The panel voted 1-13 and 2-12 against either NDD or DD approval, respectively. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for AZ/Fibrogen and Akebia/Otsuka’s vadadustat.

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 Acquires Protomer Technologies

Lilly announced the acquisition of Protomer Technologies for an undisclosed amount, although Lilly said the deal is valued at >$1B, including development and commercial milestones. For context, Protomer (view website) is a private biotech company developing novel drug therapies, including glucose-responsive insulin. Below, FENIX provides thoughts on the acquisition in the context of other glucose-responsive programs like Novo Nordisk’s.

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.

Roxa Adcom Docs Released: FDA Mixed on Risk-Benefit

Today, FDA released the briefing documents for the July 15 roxadustat advisory committee. Overall, the documents have a mixed tone, making the outcome unclear for the two voting questions posed to the 15 voting panelists. Below, FENIX provides highlights and insights from the documents, including a prediction that the adcom vote will be split while still favoring Fibrogen/AZ due to the composition of the adcom panel.

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.