Category Archives: Bolus Insulin

Adocia Pramlintide+Insulin Positive Ph1b Topline Results

Adocia announced positive results of a Ph1b study of its pramlintide+human insulin fixed-ratio combination, also called M1Pram or ADO09. Adocia is planning to host a webcast (in French) on Monday, April 27 at 12pm ET to further discuss the results. Below, FENIX provides highlights of the results and insights in the context of Xeris’s pram-insulin which is currently in Ph2 development.

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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Empa T1DM Discontinued; Lilly Q1 ’20 Earnings Update; AZ Initiates Farxiga COVID-19 Trial

Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.

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 Lilly’s “Tempo Pen” for Connected Care

In November 2019, the product labels for Lilly’s Basaglar and Humalog were updated to include administration via a new disposable connected pen called the “Tempo Pen.” Ahead of Lilly’s Q1 ’20 earnings call on Thursday, April 23, FENIX provides thoughts on the Tempo Pen since Lilly has not made any public announcements as of yet.

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 Offers Free Insulin in COVID-19 Response

Novo Nordisk announced plans to give away 90-day supplies of insulin for people who have lost their health insurance due to the COVID-19 pandemic. Below, FENIX provides thoughts on Novo’s response as well as insight into how Novo could be using the program for lead generation and to neutralize biosimilar insulin competition.

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.

CHMP Agenda March 23-26; Lilly Halts Trial Enrollments Over COVID-19 Concerns

The CHMP agenda for this month’s meeting (March 23-26) has been released, and it includes two notable items (high-dose Trulicity Day 120 questions and Biocon/Mylan bs-aspart clock stop extension). Of note, as of the publication of this blast, the March CHMP agenda does not include the “Annex” section, so it is possible that other diabetes-related items are also being reviewed. Separately, Lilly announced it was halting new trial initiation and pausing trial enrollment for most of its clinical studies amid COVID-19 concerns. Below, FENIX provides diabetes-related highlights and insights from the March 2020 CHMP agenda and Lilly 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.

Xeris Home Delivery via Amazon; Oramed End-of-Ph2 FDA Feedback

Two diabetes news items were observed today. First, Xeris made Gvoke PFS available for home delivery via Amazon Pharmacy and grounded its field force (press release). Of note, Gvoke PFS is now available for home delivery to commercially insured patients through PillPack by Amazon Pharmacy and Xeris has grounded its field force. Additionally, Oramed announced positive feedback from its oral insulin ORMD-0801 End-of-Phase2 (EoP2) CMC meeting with the FDA (press release). Below, FENIX provides highlights and thoughts surrounding these updates, including how the home delivery option could present an opportunity for Xeris and Zealand amid the COVID-19 pandemic.

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 Join New Part D Senior Savings Model for Affordable Insulins; Welldoc Partners With Dexcom

Yesterday, FENIX observed a series of diabetes-related news including an announcement that Welldoc partnered with Dexcom to integrate G6 into the BlueStar platform (press release) as well as Lilly plans to participate in the new Part D Senior Savings Model for affordable insulins (press release). Below, FENIX provides brief thoughts on these announcements.

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.

MannKind Q4 ’19 Earnings Update

MannKind hosted its Q4 and FY 2019 earnings call and highlighted its new strategy to focus on two therapy areas: endocrinology and orphan lung diseases. Additionally, MannKind laid out its roadmap for an Afrezza pediatric indication. 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.

CREDENCE CHMP Opinion This Week? DAPA-HF Filed with EMA; CHMP Agenda February 24-27

The CHMP agenda for this month’s meeting (February 24-27) has been released, and it includes two notable items (CREDENCE opinion and DAPA-HF filing) as well as some others. Below, FENIX provides diabetes-related highlights and insights from the February 2020 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.

Biocon Insulin Manufacturing Facility Fails Another FDA Inspection

Biocon issued a press release stating it received a Form 483 with three observations following an FDA inspection (Feb 10-21) of its Malaysian manufacturing facility. The deficiencies were noted by FDA during the pre-approval inspection for the company’s biosimilar glargine. Recall, during Biocon’s recent earnings call, Biocon disclosed FDA has set an action date in June 2020. Below, FENIX provides brief thoughts on the failed inspection and how it could impact US commercialization of its bs-glargine product.

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.