Category Archives: Basal Insulin

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.

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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.

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Purchase Blast$599.00

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Xeris Positive Ph2 Data in PBH; Oramed Partnership with Tianhui; Glooko Privacy Shield Certification

Three news items have been observed today across diabetes players including Xeris, Oramed, and Glooko. Xeris announced positive data from their Ph2 trial in post-bariatric hypoglycemia, Oramed has partnered with Tianhui Incubator of Technologies to launch ORMD-0801 in China in 2 years, and Glooko announced Privacy Shield certification from the US Department of Commerce. Below, FENIX provides context and insights on these news items. Xeris Reports Positive Ph2 Data in Post-Bariatric Hypoglycemia Xeris announced positive results from the in-clinic stage of the Ph2 study evaluating their ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery. Participants in the trial were……

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.

Positive Lannett Bs-Glargine Ph1 Results; Zealand Initiates 2nd Ph3 CHI Study

Lannett has announced positive results from the Ph1 PK/PD study evaluating their biosimilar insulin glargine vs. Lantus, which initiated in June 2019. In light of meeting all primary endpoints, Lannett indicated they are planning to meet with FDA to discuss the next steps for bs-glargine development. Below, FENIX provides context and insights, particularly related to the FDA’s recent biosimilar insulin draft guidance.

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.

Toujeo Pediatric Indication Approved in US

The FDA has approved an expanded indication for Sanofi’s Toujeo in pediatric patients aged 6 years and older based on the positive results from EDITION JUNIOR, which were announced earlier this month. Previously, Toujeo was only approved for adults aged 18 and over. A Sanofi press release has not yet been observed. Below, FENIX provides context and insights on the expanded indication.

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.

Sanofi Head of Strategy to Leave End of November

Reuters is reporting that Muzammil Mansuri, Sanofi’s EVP of strategy and business development, is set to leave the company at the end of November 2019. The same report says that Alban de la Sabliere and Laurent Van Lerberghe will assume Mansuri’s responsibilities. Below, FENIX provides brief thoughts on Mansuri’s departure in the context of the larger management and strategy changes within the Sanofi organization.

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 to Invest $400M in Diabetes Manufacturing

Lilly announced plans to invest $400M in its Lilly Technology Center campus in Indianapolis. The capital investment is said to include enhancements to existing manufacturing facilities that make Lilly insulin, expanding capacity for other marketed diabetes products, and initial capital investments for future medicines. Below, FENIX provides brief thoughts on Lilly’s investments including insights into which products are likely benefiting.

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.