Category Archives: Bolus Insulin

Thoughts on ADA 2020 Standards of Care

ADA recently updated its Standards of Medical Care in Diabetes for 2020, which includes key additions across multiple drug classes. Of note, the standards now include a recommendation for initiating SGLT2i or GLP-1RA therapy in patients with ASCVD, HF, or CKD (SGLT2i only) who are already at their A1C goal. Interestingly, while the guidelines were updated to include discussion of the CANVAS/R, CREDENCE, DECLARE, REWIND, and CARMELINA trials, CAROLINA and DAPA-HF trials were not addressed. Below, FENIX provides thoughts and market implications for selected guideline updates.

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 Launches Insulin Savings Program

With the start of the new year, Novo Nordisk announced the launch of its insulin savings program called “My$99Insulin” as well as authorized generics (AG) of NovoLog and NovoLog Mix products. With the My$99Insulin program, patients are able to purchase “up to three vials or two packs of FlexPen/FlexTouch/Penfill pens of any combination of insulins from Novo Nordisk Inc. for $99.” Recall, Novo first disclosed plans to offer its insulin affordability program in September 2019. Below, FENIX provides additional thoughts on the My$99Insulin program.

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.

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.

We are sorry, but you do not have access to this article.
If you already have an account, please Login. If you have any questions or would like to subscribe to our services, please contact Brady.
Contact BradyLog In

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.

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.

Teplizumab Regulatory Update; Sanofi Partners with Biocorp; Livongo Preferred on ESI; Omnipod Horizon Pivotal Trial Initiated; Glooko Partners with Mellitus Health

A series of diabetes-related new items were observed today including an update on Provention Bio’s teplizumab, a new Sanofi/Biocorp connected pen partnership, Livongo’s preferred status on ESI, Insulet’s Omnipod Horizon pivotal study, and more. Below FENIX provides insights and context from each respective news item.

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.

Would AZ, Teva, or Mylan/Upjohn Buy Sanofi’s DCV Business?

Earlier this week, Sanofi hosted its 2019 Capital Markets Day and the company disclosed plans to re-structure its diabetes and cardiovascular business. As part of the discussion, senior management entertained the idea that it would consider divesting the business and/or its assets if it found the right suitor. Below, FENIX provides analysis of companies who could potentially be interested in Sanofi’s DCV assets and why AstraZeneca, Teva, or even Viatris (Mylan/Upjohn) could be viable options.

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.

Sanofi To Move Away From Diabetes/CV; Sanofi 2019 Capital Markets Day

Sanofi hosted its 2019 Capital Markets Day and outlined its new strategy including the R&D focus, which does not include diabetes or cardiovascular projects. In a separate press release, Sanofi also announced it is restructuring the deal with Regeneron for Praluent and Kevzara. Below, FENIX provides CV/Met related highlights from the CMD presentation as well as thoughts on the new direction for Sanofi’s business.

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.

High-Dose Trulicity Filed in EU (CHMP Agenda December 9-12)

The CHMP agenda for this month’s meeting (December 9-12) has been released, and it includes two notable items (potential oral semaglutide opinion and high-dose Trulicity was filed). 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.

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 uRAI (AT247) Positive Topline Results

Arecor announced positive topline results for a Ph1 study of its ultra-rapid-acting insulin (AT247). Arecor did not provide any specifics of the Ph1 data, but the company plans to publish and present results from the study in 2020. Below, FENIX provides brief thoughts on AT247 and its market potential.

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.

Thoughts on FDA Bs-Insulin Draft Guidance; Did Development Just Get Easier?

Yesterday, FDA issued a new draft guidance titled, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” In the draft guidance, FDA outlines its updated thinking on the need for immunogenicity studies for biosimilar insulin products. Recall, on March 23, 2020, insulin products are being reclassified as biologics, and biosimilars will be governed by the 351(k) pathway. Below, FENIX provides an overview of the FDA’s new draft guidance and implications to the insulin market since it appears that the barriers to developing biosimilar insulins have been significantly reduced.

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.