Tag Archives: Diabetes

HF Trial Draft Guidance Issued by FDA; Public Hearing in July 2019

FDA announced it has issued draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry” (download HF draft guidance here). Additionally, FDA will be hosting a public workshop on Friday, July 26, 2019, from 9am to 4pm ET at the White Oak Campus.

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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High-dose Trulicity Topline Results; Jardiance Fast Track Designation for HF

Lilly announced positive topline results from its AWARD-11 study evaluating high-dose Trulicity (3.0 and 4.5mg). Separately, Boehringer Ingelheim and Lilly announced they have received Fast Track designation for the Jardiance heart failure indication based on the ongoing EMPEROR clinical trials. Of note, Lilly did not provide details on the A1C or weight reduction observed in AWARD-11. Below, FENIX provides insight and context on the Jardiance HF Fast Track designation as well as thoughts on AWARD-11 and the potential magnitude of effect with Trulicity 3.0 and 4.5mg doses.

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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DECLARE CHMP Decision This Week; Sanofi BS-Aspart Filed in EU? CHMP Agenda Highlights

The CHMP agenda for this week’s meeting has been released, and it includes some notable diabetes decisions including AZ’s DECLARE CVOT label update (Type II variation). Additionally, there is a new application for insulin aspart which is believed to be from Sanofi. Below, FENIX provides diabetes-related highlights and insights from the 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.

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Adocia’s Pramlintide + Insulin Combo (ADO09) Ph1b Trial Posted on CT.gov

Consistent with Adocia’s ADA 2019 press release, a clinicaltrials.gov record has recently been observed for the company’s pramlintide + insulin (ADO09) Ph1b study. Below, FENIX provides an overview of the ADO09 Ph1b trial including thoughts on the market potential for ADO09 as a T1DM adjunctive therapy.

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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New Semaglutide High-Dose T2DM Ph3 Trial (SUSTAIN FORTE)

Novo Nordisk’s Ph3 T2DM high-dose semaglutide trial (SUSTAIN FORTE) has recently been posted on CT.gov. Recall, Novo first disclosed its plans to study high-dose semaglutide in T2DM patients during its Q3 ’18 earnings call. Below, FENIX provides insight into SUSTAIN FORTE including context from Lilly’s recently initiated SURPASS-2 trial (tirzepatide vs. Ozempic) and the ongoing AWARD-11 high-dose Trulicity trial.

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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Sanofi R&D Re-focusing; R&D Layoffs in France and Germany

According to Reuters, Sanofi is set to layoff 466 R&D-related jobs as part of an initiative to prioritize oncology, immunology, rare diseases, and vaccines while at the same time limiting internal CV R&D to its current pipeline. Furthermore, Sanofi is said to maintain the support of its diabetes and CV programs through its partners. Below, FENIX provides thoughts on the Sanofi R&D re-focusing in the context of the company’s CV/Met pipeline and recent senior management changes.

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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New Tirzepatide vs. Ozempic H2H Ph3 Trial (SURPASS-2)

Lilly initiated its Ph3 tirzepatide vs. Ozempic H2H study (SURPASS-2) which is the 4th tirzepatide pivotal trial (not including Japan). The final pivotal trial, SURPASS-5 (add-on to basal insulin), is projected to initiate shortly. Below, FENIX provides an overview of SURPASS-2 as well as insight into the curious observation that the trial does not specify which dose of Ozempic is being used (0.5 or 1.0mg). 

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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Victoza Pediatric Indication Approved in US

Victoza has been approved by FDA for use in pediatric patients down to 10 years of age. Of note, the pediatric indication was approved as a priority review. Results of the ELLIPSE Victoza pediatric study were recently presented at the Pediatric Endocrine Society/PediatricAcademic Societies annual meeting and subsequently published in the NEJM. A Novo press release has not yet been observed. Below, FENIX provides brief thoughts on the approval including the impact to Victoza’s market exclusivity extension.

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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Xeris Glucagon Ph3 Top-line Data vs. Novo’s GlucaGen

Xeris announced topline results from the fourth Ph3 trial evaluating its stable glucagon formulation for hypoglycemia rescue. This Ph3 crossover study demonstrated that Xeris’s glucagon was non-inferior to Novo’s NovoGen in terms of achieving a plasma glucose >70mg/dL or a ≥20mg/dL increase in 30 minutes following administration. Recall, Xeris recently announced that FDA requested an additional 3 months to review the company’s NDA submission with a new action date on September 10, 2019. Below, FENIX provides brief thoughts on the Ph3 crossover trial in the context of the ongoing Xeris glucagon regulatory review.

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.

Pfizer’s Oral GLP-1RA Advances to Ph2

Pfizer initiated the first Ph2 study evaluating its oral, small-molecule GLP-1RA (PF-06882961) in 400 T2DM subjects. Recall, during Pfizer’s Q1 ’19 earnings call, senior management said they intended to “swiftly” bring PF-06882961 into Ph2. Below, FENIX provides potential insight into the Ph2 study as well as context from other oral GLP-1RAs in development.

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.