Category Archives: Topics

Dexcom Partners with Current Health for Remote Patient Monitoring; Nemaura to Integrate with Activity Trackers; Roche Q2 ’20 Earnings Update

Three diabetes-related news items have been observed: Dexcom has partnered with Current Health for remote patient monitoring, Nemaura announced it will integrate activity tracker data into its proBEAT app and Roche hosted its Q2 ’20 earnings call (press release; slides). Below, FENIX provides highlights and insights 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.

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New Non-Invasive CGM Player Emerges (Movano); Dexcom G6 Direct-to-Apple Watch Delayed?

Last week, Movano Inc. (view website), the developer of a novel non-invasive CGM, announced it exited “stealth mode” following the receipt of $10M in additional funding. Since its founding in 2018, the company has raised a total of $27M. Below, FENIX provides insight into the new Movano CGM in the context of other non-invasive CGM technology as well as thoughts on Dexcom’s apparent delayed launch of its direct-to-Apple Watch feature and Abbott’s potential to offer a similar feature for Libre 2.

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 Fate Therapeutics Updates to their CAR-T Programs in DLBCL and MM; Q1 2020 Call

On Monday, May 11, Fate Therapeutics held their Q1 2020 earnings call (press release), highlighting clinical and preclinical development updates to their pipeline, operational progress, and the recently established collaboration with Janssen for iPSC-derived CAR-NK and CAR-T assets. Below, FENIX provides thoughts on Fate’s cell therapy clinical strategy, particularly in the context of the current 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.

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.

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 UHC’s New T2DM-focused Digital Care Platform (Level2); Implications to Dexcom and Other Coaching Solutions

Last week, UnitedHealthcare launched a new program, called Level2 (view website here), for T2DM patients. The program combines wearable technology from Dexcom and Fitbit with personalized support tools, including coaching. A Level2 pilot is currently being expanded to 27 states and Washington, D.C. Later this year, UHC intends to make Level2 more broadly available for free to its 230,000 eligible members. Below, FENIX provides an overview of the Level2 program, potential insight into UHC’s motivation to create Level2, implications to Dexcom, and thoughts on the potential impact on similar solutions from companies like Livongo, Onduo, Omada, Welldoc, etc.

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.

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.

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 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.

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.

JNJ BCMA CAR-T, JNJ-4528, US filing on track for YE 2020, but EU delayed to H1 2021; JNJ Q2 2020 earnings call

Thursday, 16 July, JNJ held their Q2 2020 earnings call (press release / slides). The company confirmed that filing of their BCMA CAR-T for multiple myeloma, JNJ-4528 (cilta-cel), remains on track for YE 2020 in the US. However, EU filing has been pushed back slightly to early 2021 (from YE 2020). Meanwhile, despite the impact of COVID-19, JNJ reported double-digit QoQ growth of its multiple myeloma blockbuster, Darzalex (US +33%; WW +16%). Below, Celltelligence provides further context on JNJ-4528 and how Darzalex’s sales resilience could help support continued CAR-T development and future commercialization.

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 Farxiga hHF Post-MI Study (DAPA-MI) Receives Fast Track Designation; Abbott and J&J Q2 ’20 Earnings Updates; Dexcom G6 Temporary Approval in Pregnancy by Health Canada

A series of diabetes-related news has been observed: AstraZeneca announced it received Fast Track designation for Farxiga to reduce the risk of hospitalization for heart failure following an acute MI based on the new DAPA-MI study, JNJ (press release; slides) and Abbott (press release) hosted their Q2 ’20 earnings calls, and Dexcom announced Health Canada provided temporary approval for use of G6 in pregnant women in response to COVID-19. Below, FENIX provides a comparative analysis of DAPA-MI relative to BI/Lilly’s EMPACT-MI study as well as highlights and insights from the other news items, notably Abbott’s commentary on Libre 2 and Libre 3.

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 Autolus’s Preclinical Pipeline Update; AACR II 2020 Investor Call Summary

On Thursday, June 25, Autolus held an investor call (press release / presentation), highlighting updated preclinical data from their AUTO5 (T cell lymphoma), AUTO6NG (neuroblastoma, osteosarcoma, small cell lung cancer, and melanoma), and AUTO7 (metastatic castration-resistant prostate cancer, mCRPC) programs. Below, Celltelligence provides thoughts on the significance of these data sets, and the potential impact that Autolus’s next-generation CAR-T products could have on treating solid tumors.

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.