Category Archives: Other

Thoughts on New Hygieia d-Nav Mobile App for Insulin Titration; New Data published in The Lancet

Hygieia recently announced it received 510(k) clearance for a mobile app that is part of the company’s d-Nav insulin guidance service. Recall, d-Nav is a T2DM-focused, cloud platform that provides personalized insulin dose recommendations based on the user’s BGM values. Additionally, results were published in The Lancet for a study showing d-Nav plus HCP support led to superior glycemic control than with HCP support alone. Below, FENIX provides thoughts on how Hygieia’s d-Nav and other similar systems could impact the diabetes market.

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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Lilly to use PRV for REWIND? Novo Q4 ’18 London earnings update

Novo Nordisk hosted its post-Q4 ’18 earnings event in London. The session included a brief presentation from management followed by Q&A which primarily focused on Novo’s priority review voucher (PRV) for oral semaglutide. Below, FENIX provides highlights and analysis from the call, as well as the scenario that Lilly could use its PRV for REWIND to keep pace with Novo.

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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Merck Q4 ’18 Earnings Update

Merck held its Q4 ‘18 earnings call and briefly discussed its diabetes portfolio. Of note, Merck’s earnings press release highlighted the recent in-licensing of NGM313, renamed MK-3655 (monoclonal antibody agonist of the β-Klotho/FGFR1c receptor), which is being evaluated in T2DM and NASH. Additionally, senior management announced that the company will hold an investor event on June 20, 2019 to provide an update on Merck’s strategic progress and its plans for the future. Below are highlights 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

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Livongo Acquires Behavioral Health Company

Livongo announced its intention to acquire myStrength, a Colorado-based behavioral health company focused on chronic conditions including depression, anxiety, stress, substance use disorder, chronic pain, opioid addiction and recovery, and insomnia. Below, FENIX provides insight into the acquisition including thoughts on how Livongo may be leveraging myStrength to expand Livongo’s core diabetes business.

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.

Oramed Initiates Ph1 Oral GLP-1RA; Zafgen and vTv Ph2 data

Oramed has initiated its first ORMD-0901 (oral GLP-1RA) Ph1 study under its FDA IND application. Additionally, Zafgen and vTv Therapeutics recently announced data from their respective Ph2 programs for ZGN-1061 (MetAP2 inhibitor) and TTP399 (glucokinase activator). Below, FENIX provides an overview of the Oramed Ph1 study, Zafgen and vTv Ph2 data, and thoughts the viability of each program in the antihyperglycemic market. Oramed Ph1 Oral GLP-1RA initiation Oramed announced the initiation of its first Ph1 study under their FDA IND application. Recall, The IND was granted in September 2018. According to the press release, the Ph1 trial is a randomized, single-blinded crossover……

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

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New Afrezza TV DTC campaign on Jan 14, 2019

Today, MannKind hosted a business update call and provided guidance on Afrezza commercialization and their financial position. MannKind held this call as they are not presenting at the upcoming JPM healthcare conference (Jan 7-10, 2019). Of note, management indicated it has increased its consumer focus on Afrezza to drive greater uptake in 2019 by launching an Afrezza TV DTC campaign on January 14, 2019. Additionally, the company commented on CGM market penetration as a potential growth driver for Afrezza in 2019 and beyond. Below, FENIX provides diabetes-related highlights from the call. Afrezza TV DTC– On January 14, 2019, MannKind plans to launch an Afrezza TV DTC……

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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Happy Holidays from FENIX!

This holiday season, we genuinely thank you for your readership to our FENIX news updates. In the year 2018, we successfully shared 350+ updates on the most current diabetes news with impactful market insights using our deep thought leadership. We look forward to another successful year in 2019. Have a safe and happy holiday break! Warm regards, FENIX Team :)… If you receive our email blasts, you already have an account. Log in nowContext counts when making decisions.Purchase Blast$599.00You can read the article’s full content online after purchase. About The Author Matthew Maryniak | President of Fenix Group International Matthew…

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.

LX2761 positive Ph1 topline results and JDRF’s 2018 T1D research developments

Yesterday, Lexicon announced positive topline results from their Ph1 studies of oral SGLT1i ‘LX2761’ and JDRF announced its overall T1DM research developments from 2018. Below, FENIX provides additional thoughts on each topic. LX2761 Ph1 topline results LX2761 Ph1 topline results contained data from two studies, including a Ph1a single ascending-dose study in healthy, T2DM patients and a Ph1b multiple ascending-dose study in T2DM patients. The timing of this announcement is aligned with guidance from Lexicon’s Q3 ’18 earnings call, which indicated topline results by YE ’18 (previous FENIX insight). Notably, a brief CT.gov search for Lexicon’s LX2761 Ph1 studies did not show……

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

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Thoughts on 2019 ADA Standards of Care

The ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Of note, the ADA has aligned their CVD recommendations with the ACC’s recent T2DM ASCVD recommendations. The ADA also added a new dedicated section titled “Diabetes Technology,” which includes information previously incorporated in the “Glycemic Targets” section. The ADA also provides a cost breakdown of pharmacologic treatment options. Below, FENIX has provided highlights and insights from the updated ADA 2019 Standards of Care.

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.

Onduo-Walgreens T2DM strategic partnership

Yesterday, Verily announced a strategic partnership with Walgreens Boots Alliance (WBA) to improve health outcomes for patients with chronic conditions, including diabetes. Of note, WBA is Verily’s first retail pharmacy development and commercialization partner. Below, FENIX provides additional thoughts on this partnership in relation to Sanofi/Verily’s joint venture ‘Onduo’ and Dexcom. According to the press release, Verily and WBA will focus on developing a medication adherence pilot project that will utilize devices and other approaches to improve adherence. Under this collaboration, Walgreens and Onduo will launch a “Virtual Diabetes Program” through the Walgreens employee health plan to those with T2DM. This service will include coaching and remote access to specialty care services. The financial……

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.