Tag Archives: Diabetes

Novo Semaglutide Pen Story Continues to Evolve

Novo initiated a Ph1 trial evaluating its new semaglutide injection pen (DV3396) as well as “two different forms of semaglutide” in patients who are overweight or obese. Recall, Novo recently initiated a separate Ph2 trial comparing injection site pain with DV3396 and FlexTouch pens. Below, FENIX provides updated insights regarding the DV3396 injection device based on new information from this Ph1 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.

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New Ozempic Pen Ph2 Trial

A CT.gov record has been observed comparing FlexTouch (PDS290) to the DV3396 pen which appears to be a modified version of the previously studied DV3372 pen (previous FENIX insight). Below, FENIX provides additional insight into Novo’s next-gen semaglutide pen platform.

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.

Biocon Malaysian Facility Receives Additional 483 Observations From FDA

Biocon has received an additional twelve 483 observations from an FDA inspection of Biocon’s Malaysian facility. The 483 observations were a result of an FDA pre-approval inspection for the bs-glargine product; however, the company did not provide any specific details. No result was found during a search of FDA’s inspection citations. According to Biocon, the inspection is not anticipated to impact plans for US commercialization. Below, FENIX provides context and insight regarding these 483 observations.

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.

Janssen-Hanmi Ends Ph2 Dual Agonist; Sanofi Efpeg Deal Restructured

Recently, there have been two seemingly interrelated announcements from Hanmi regarding the termination of their GLP-1/GCG dual agonist partnership with Janssen and a restructuring of the deal with Sanofi for efpeglenatide. Below, FENIX provides a summary of these news items and potential read-through.

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.

Connected Care: Sanofi/Biocorp Exclusive Data Partnership

Today, Biocorp and Sanofi announced they have entered into exclusive negotiations for integrating Biocorp’s connected cap device into the Sanofi connected care platform. Below, FENIX provides read-through on what the Biocorp-Sanofi deal may signal.

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.

Beta Bionics Raises $63M in Series B2 Financing

Beta Bionics announced the closing of a $63M Series B2 financing round 6 months after an additional $63M Series B round. According to the press release, the funds will be used to complete final product development, Ph3 clinical trials, regulatory submissions, and the commercial launch of the iLet system. Below, FENIX provides additional thoughts on Beta Bionics and the iLet system.

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 OneDrop/Apple BGM Distribution

One Drop recently announced that its BGM platform is now available in select US Apple stores. The One Drop BGM platform, which includes a mobile app, integrates with Apple HealthKit and is able to send data directly to an iPhone or Apple Watch. This is One Drop’s second large distribution agreement in 2019. In March, One Drop announced a partnership with Amazon to be part of Amazon’s Choice. Below, FENIX provides thoughts on why the distribution agreement makes sense for both One Drop and Apple.

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.

Farxiga DECLARE Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the DECLARE CVOT. AZ is anticipated to comment on the US and EU DECLARE regulatory activities during its upcoming Q2 ’19 earnings call on July 25. Below, FENIX provides brief thoughts on the impending EMA approval in the context of the ongoing FDA 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.

Livongo Files for IPO

Livongo has filed for its IPO under the proposed ticker “LVGO”; however, the number of shares and price has not yet been decided. Recall, on March 7, 2019, it was reported by WSJ that Livongo was preparing for a 2019 IPO with a valuation >$1B. Below, FENIX provides a brief overview of key information from the S-1 filing as well as insight into the Livongo IPO including thoughts on how Livongo is under increasing pressure to drive adoption.

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.

Xeris/Insulet Partnership Discontinued? Ph2 Xeris Glucagon Bariatric Surgery Trial

Xeris Pharmaceuticals announced the first patient has been dosed in the Ph2 trial evaluating its ready to use glucagon in patients who experience hypoglycemia after undergoing bariatric surgery (PBH). Xeris previously discussed intentions to initiate this Ph2 trial in a press release from December 2018. Curiously, neither of the press releases nor the CT.gov record makes any reference to delivery via the Insulet Omnipod which had been used in previous Xeris clinical trials with published clinical results. Below, FENIX provides insight into potential reasons why this trial is not using Omnipod.

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.