Tag Archives: NOVO

Farxiga DAPA-HF receives priority review; Fiasp pediatric approval in US; MannKind launching in Brazil

A series of diabetes-related news items were observed today from AstraZeneca, Novo Nordisk, and MannKind. AZ announced FDA filing acceptance and granting of priority review for the Farxiga DAPA-HF sNDA. According to AZ, the PDUFA date is in Q2 2020. Additionally, Novo announced US approval of Fiasp for pediatric populations. Further, MannKind announced that it has received approval of the proposed price of Afrezza in Brazil, and intends to commence marketing and distribution the week of January 13, 2020. Below, FENIX provides context and insights regarding these 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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Mylan Challenges Novo on Victoza Patent Dispute; Lexicon, Poxel, MannKind, and Diamyd Clinical Data

Mylan has challenged a patent for Novo Nordisk’s Victoza. Additionally, several diabetes players including Lexicon, Poxel, MannKind, and Diamyd have announced clinical results before the holiday break. Below, FENIX provides contexts and insights on these news items.

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FENIX Analysis: Rybelsus Launch

Following the September 2019 Rybelsus approval, Novo Nordisk initiated a limited launch in October 2019 to specialists and high-prescribing PCPs. Even with the limited promotional support, Rybelsus appears to be off to a highly successful start, ahead of both Trulicity and Ozempic time-aligned launches. Below, FENIX has conducted a launch analysis, including early insights from NRx trends as well as an overview of both field and digital promotion materials.

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/UVA Partnership; Roche Decreases Eversense CGM Commitment; Lilly Insulin Pricing Open Letter

A series of diabetes-related news has been observed including a new partnership between Novo Nordisk and UVA, Roche amended its agreement with Senseonics to reduce the minimum CGM volume obligation, and Lilly publishes an open letter on insulin pricing. 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

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Novo 2019 Capital Markets Day Highlights and Analysis

Novo hosted its 2019 Capital Markets Day and provided updates on the strategic direction of the company through 2025 including commercial activities and R&D strategy. Of note, Novo provided clarity on Rybelsus positioning vs. Ozempic and competitor products as well as details on novel drug delivery technologies, including two oral peptide delivery methods being developed at MIT and the semaglutide+AM833 injection device. Below, FENIX provides details 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

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

New Novo Partnership with Dicerna for RNAi Therapeutics

Novo Nordisk and Dicerna announced a partnership for the discovery and development of RNAi therapeutics targeting liver-related cardio-metabolic diseases including T2DM, NASH, obesity, other chronic liver diseases, and rare diseases. Following the announcement, Dicerna hosted a call with investors to discuss the implications to its business. Below, FENIX provides thoughts on the Novo/Dicerna partnership, particularly in the context of Dicerna’s other existing partnerships including Lilly and Boehringer Ingelheim (separately from the BI/Lilly CV/Met alliance).

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 Q3 ’19 London Earnings Update

Novo Nordisk hosted its post-Q3 ’19 earnings event in London. Consistent with previous quarters, the session included a brief presentation from Novo management followed by Q&A. Below, FENIX provides highlights and insights from the call including additional thoughts on Novo’s improved oral semaglutide formulation.

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 has a PCSK9i; Novo Q3 ’19 Earnings Update

Novo Nordisk hosted its Q3 ’19 earnings call (press release) and provided updates to its diabetes business, including details on the Ozempic and Rybelsus launches, discontinuation of an oral GLP-1RA (OG2023SC) due to promising new formulations of oral semaglutide, and other pipeline activities. Of note, Novo disclosed that it is developing a PCSK9i compound for potential co-formulation with its other pipeline products. 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.

New Semaglutide Formulations in Ph2 Pen Trial

A CT.gov record for a new Ph2 trial has been observed comparing FlexTouch (PDS290) to the DV3396 pen as well as two different formulations of semaglutide (“Semaglutide B” and “Semaglutide D”). Recall, in July 2019, Novo initiated a nearly identical Ph2 study evaluating two formulations of semaglutide in the same injectors. Below, FENIX provides updated insights regarding the trials, DV3396 injection device, and the new semaglutide formulations.

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.

Fiasp Approved for Pump Use in US

Novo Nordisk announced FDA approved Fiasp pump compatibility in adults with T1DM and T2DM. According to Novo, the updated label is based on data from the Onset 5 clinical trial (CT.gov record). Recall, Onset 5 demonstrated non inferiority in the primary outcome measure of change in A1C, but failed to show superiority. Below, FENIX provides context and insight surrounding the approval, including read-through to Lilly’s ultra rapid-acting insulin lispro (URLi).

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.