Category Archives: Bolus Insulin

Lexicon Reports Remaining Topline Ph3 Sota T2DM Results; Biocon Partners with Voluntis For Digital Insulin Solution

Two diabetes-related news items have been observed: Lexicon reported topline results from the four remaining sotagliflozin T2DM Ph3 trials and Biocon partnered with Voluntis to integrate Biocon bs-insulins with Voluntis’s Insulia automated dose calculator. Below, FENIX provides thoughts on the Lexicon Ph3 sota T2DM data in the context of the company’s decision not to move forward in T2DM without a strategic partner as well as potential insight into the Biocon/Voluntis partnership.

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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IQVIA/JDRF Partner for T1DM Research; MannKind Hires Former Medtronic Exec as CCO; Insulet Initiates Horizon Preschool Trial; Adocia Q2 ’20 Earnings; Dario Partners for UK Distribution

A series of diabetes-related news items have been observed including: IQVIA and JDRF are collaborating to use real-world data to better understand T1DM, MannKind announced Alejandro Galindo (former head of Medtronic’s automated insulin delivery business) is joining the company as the new CCO, Insulet initiated a new Omnipod Horizon trial in preschool-aged children (view CT.gov record), Adocia released its Q2 ’20 earnings (view press release; a webcast was not held), and Dario Health has partnered with Williams Medical for UK distribution. Below, FENIX provides highlights and insights for the respective news items, including why the IQVIA-JDRF partnership is interesting to manufacturers of CGM systems and insulin products.

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.

High-dose Trulicity CHMP Opinion this week?; CHMP Agenda July 20-23

The CHMP agenda for this month (July 20-23) has been released, and it includes one notable item, a potential high-dose Trulicity CHMP opinion, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the July 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.

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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Lyumjev (ultra-rapid lispro) Label Analysis and Supply Conversion Thoughts

Last week, FDA approved Lilly’s ultra-rapid lispro as “Lyumjev,” pronounced [LOOM-jehv] as the second ultra rapid-acting injectable insulin behind Novo’s Fiasp. Of note, the generic name for Lyumjev is lispro-aabc. Below, FENIX provides an in-depth Lyumjev label analysis, including a comparison with Novo on RAI supply conversion strategy, and potential insights into Lilly’s connected pen solution.

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Xeris Ph2 Pramlintide+insulin Co-formulation Topline Results

Xeris Pharmaceuticals announced positive topline results from a Ph2 trial evaluating its pramlintide-insulin co-formulation (XP-3924). Xeris said it is planning for an end-of-Ph2 meeting with FDA later in 2020 to discuss the XP-3924 development path. Below, FENIX provides an overview of the topline results as well as thoughts on the market potential of XP-3924 in the context of other similar products, notably Adocia’s ADO09 (M1pram).

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.

Dapa Reduces Progression to T2DM; Teplizumab Continues to Delay T1DM Onset; Arecor AT247 Faster than Fiasp; ADA Key Press Releases (June 15)

Today, twelve diabetes-related news items were observed: DAPA-HF delays T2DM onset, teplizumab follow-up results, Arecor uRAI Ph1 data, new Afrezza practical data, Diasome HDV Ph2 results, Hua Medicine Ph3 GKA data, ORMD-0801 in NASH, Glytec CGM POC data, Biolinq’s first-in-human CGM data, and more. Below, FENIX provides context and analysis for the 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.

Lilly’s Lyumjev FDA Approved (ultra-rapid lispro)

Today, FDA posted a label for Lyumjev (ultra-rapid lispro) in the Drugs@FDA database ahead of a Lilly press release (see direct link here to the label in PDF). FENIX will have a full label analysis in the coming days.

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.

Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE at ADA 2020; Sota T2DM CKD Data; vTv Presents TTP399 Ph2 Results; ADA 2020 Key Press Releases (June 13)

Today, nine diabetes-related news items were observed: Trulicity, Ozempic, Afrezza, Libre, Control IQ, and Onduo RWE data were presented at ADA 2020 as well as new data from Lexicon (sota T2DM Ph3 CKD), vTv (Ph2 Simplici-T1), and Zealand (V-Go patch pump). Below, FENIX provides context and analysis for the 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.

New MPD Insulin Savings Program Supported by Lilly, Novo, and Sanofi

Yesterday, President Trump announced a new plan to reduce the monthly cost of insulin to no more than $35 for people on Medicare Part D. The plan, which is scheduled to go into effect on January 1, 2021, is being supported by Lilly, Novo Nordisk, and Sanofi. Following the announcement, Lilly’s CEO, Dave Ricks, issued a statement lauding the new savings model, saying it “fills a critical gap that remained in the system.” Below, FENIX provides thoughts on the new plan in the context of the overall US drug pricing debate.

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 “Defeat Diabetes” campaign; Diamyd Announces DiAPREV-IT 2 Topline Results; Senseonics Releases Android Remote Monitoring App

A series of diabetes-related news items have been observed: Novo Nordisk launched a new social responsibility campaign called “Defeat Diabetes”; Diamyd announced DiAPREV-IT 2 topline results; and Senseonics announced the launch of the Eversense NOW remote monitoring app for Android users. Below, FENIX provides highlights and insight 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.