Tag Archives: Diabetes

Zealand Dasiglucagon Pediatric Study Meets Primary and Secondary Endpoints

Zealand Pharma announced positive topline results from its pediatric dasiglucagon hypoglycemia rescue trial in pediatric patients from 6 to 17 years of age. Below, FENIX provides insights on dasiglucagon in the context of the recent Lilly Baqsimi (nasal glucagon) and Xeris (subcutaneous Gvoke) FDA approvals.

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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Insulet Omnipod DASH Pump Receives Interoperability Designation

Insulet announced it received FDA clearance for the “Omnipod DASH ACE Pump” to be classified as an alternate controller enabled (ACE) pump which allows for integration with other interoperable components (e.g. iCGM and eventually an “iAlgorithm” although no “iAlgorithms” are approved as of yet). Recall, ACE is FDA’s new designation for pump interoperability which requires manufacturers to meet a set of special controls. Below, FENIX provides thoughts on the Omnipod ACE pump designation including read-through to Insulet’s closed-loop developments (Omnipod Horizon and Tidepool Loop).

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.

AZ’s Triple FDC (Dapa/Saxa/Met) Receives Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the FDC of dapagliflozin+saxagliptin+metformin branded as “Qtrilmet.” Recall, FDA approved AZ’s triple FDC (called Qternmet XR in the US) in May 2019. Below, FENIX provides brief thoughts on the Qtrilmet positive CHMP opinion.

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 Hosts Post-approval Rybelsus Investor Call; Semaglutide HFpEF Study?

Novo Nordisk hosted an investor call to discuss the recent Rybelsus FDA approval (previous FENIX insight). Unsurprisingly, much of the investor call discussion centered around Rybelsus pricing and market access. Below, FENIX provides a Rybelsus pricing and website analysis as well as thoughts on Novo’s commentary regarding a potential semaglutide HFpEF study.

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.

Oral Semaglutide Approved as “Rybelsus”

Novo Nordisk announced FDA approval of its oral semaglutide which is now branded as “Rybelsus” (view Rybelsus US label here). Rybelsus (pronounced reb-EL-sus) appears to be a play on the word “rebel” alluding to the idea that oral semaglutide is rebelling against injectable GLP-1RA. Recall, Novo filed oral semaglutide on March 20, 2019 with a priority review voucher (PRV) which allowed for a short 6-month review. Below, FENIX provides a Rybelsus label analysis, thoughts on the impending launch, and potential insights into the upcoming CV indication PDUFAs for Ozempic and Rybelsus.

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.

REWIND Receives Positive CHMP Opinion

Lilly announced that CHMP issued a positive opinion for a Trulicity CV indication based on results from the REWIND CVOT. Below, FENIX provides thoughts on the impending Trulicity EU label update as well as potential readthrough to the ongoing FDA 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.

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 MannKind and Dance Inhaled Insulin Data; EASD 2019 Day 4

On the fourth day of EASD, 3 key press releases were observed including new inhaled insulin data from MannKind and Dance. Additionally, Xeris announced the initiation of its Ph2 pramlintide+insulin fixed-ratio combination trial. In case you missed it earlier today, FENIX also provided coverage of Novo’s Ph3b CONCLUDE data presentation (H2H Tresiba vs. Toujeo T2DM basal-only trial). Below FENIX provides insights and context from each respective announcement.

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 CONCLUDE (H2H Tresiba vs. Toujeo T2DM Basal-only Trial)

Novo Nordisk presented results at EASD from CONCLUDE, its Tresiba vs. Toujeo T2DM basal-only H2H study, and announced the results in a press release. While the trial failed to demonstrate a statistically significant benefit in the primary endpoint (severe or BG-confirmed symptomatic hypoglycemia), key secondary outcomes showed a clear benefit favoring Tresiba. It is a bit ironic that since the primary endpoint was not met, no conclusions can be made from the CONCLUDE secondary outcomes. Below, FENIX provides thoughts on the trial including a winners & losers 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.

Lexicon +188% Post DAPA-HF and Sanofi Partnership Dissolution

Over the last few months, the fate of Lexicon and sotagliflozin have remained in question; however, in recent days it appears that both have the potential to make a strong comeback. Below, FENIX analyzes Lexicon’s stock price in the context of the recent DAPA-HF results and settlement with Sanofi.

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.

Poxel Ph3 Imeglimin and vTv Ph2 TTP399 CGM Data; EASD 2019 Day 3

On the third day of EASD, 2 key press releases and one new clinical trial were observed. Of note, results from Novo Nordisk’s H2H Tresiba vs. Toujeo trial (CONCLUDE) were presented but a Novo press release was not observed. There is a dedicated session on CONCLUDE tomorrow (September 19) from 12-1pm local time. Below FENIX provides insights and context from each respective announcement.

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.