Category Archives: Uncategorized

Lilly’s Evidation Health Collaboration Expanded To Discover Novel Digital Health Measures

Today, Lilly and Evidation Health announced the expansion of their collaboration with a multi-year agreement that will provide Lilly with global access to Evidation’s Andromeda data platform. Of note, Evidation Health also has prior partnerships with Tidepool and Sanofi. Below, FENIX provides additional thoughts on this collaboration in the context of Lilly’s connected care strategy in diabetes. According to the press release, Lilly will leverage the Andromeda data platform across different therapeutic portfolios, including diabetes, to support the clinical utility of digital medicine and improve personalized health outcomes. The press release also noted that Andromeda data platform is being used……

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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Mylan invalidates two Lantus patents

Today, Mylan announced the US Patent and Trademark Appeal Board (PTAB) has dismissed two of Sanofi’s Lantus patents thereby favoring Mylan/Biocon’s biosimilar glargine. Importantly, Mylan seems to indicate that it has responded to the June 2018 CRL by describing its Lantus 505(b)(2) NDA as “…under active review…” by FDA. Below, FENIX provides additional thoughts on Mylan’s announcement in the context of a tentative approval of Mylan’s bs-glargine pending its 30-month patent litigation stay with Sanofi. Recall, Mylan filed biosimilar glargine with FDA in Q3 ’17 which triggered a 30-month stay as a result of the patent infringement lawsuit filed by Sanofi. As per the PTAB ruling, Sanofi’s……

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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Tidepool Loop funded at $6M

Today, JDRF and Helmsley Charitable Trust announced a collaborative grant agreement by providing $6M of funding to Tidepool for the development of “Tidepool Loop”. Recall, Loop is an open-source, unregulated automated insulin delivery (AID) app for iPhone that connects to an insulin pump and CGM using BLE (see image below). Of note, Tidepool intends on further developing the app by making it an FDA-regulated, hybrid closed-loop AID app for iOS with interoperability across multiple insulin pumps and CGMs. Below, FENIX provides additional thoughts on Tidepool Loop. Source: Tidepool website This news comes as no surprise considering the recent announcement from Tidepool in October 2018, indicating the initiation of the Loop project, which aimed to develop……

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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New Sanofi and Dexcom trials: Efpeglenatide add-on to MET+/-SU and G6 vs. Libre FGM

Recently, FENIX has observed new Sanofi and Dexcom trials on CT.gov. Sanofi has posted its Ph3 efpeglenatide trial (AMPLTITUDE-S) as an add-on to metformin (MET) with or without sulfonylurea (SU). Additionally, Dexcom has an investigator-initiated trial comparing the G6 CGM with Libre FGM in T1DM (ALERT-T1). Below, FENIX provides thoughts on the respective studies, as well as a comparison of GLP-1RA trials with MET+/-SU. Sanofi Efpeglenatide Ph3 study as an add-on to MET±SU (AMPLTITUDE-S) Sanofi has initiated AMPLITUDE-S for its QW GLP-1RA, efpeglenatide, as an add-on to MET±SU. Of note, this is the last pivotal study for efpeglenatide regulatory submission, anticipated to……

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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Novo partners with e-Therapeutics to target T2DM

Today, e-Therapeutics announced a partnership with Novo Nordisk to discover novel intervention strategies, biological pathways, and target compounds for T2DM. According to the press release, Novo will work with e-Therapeutics for a 12-month period and use its proprietary Network-Driven Drug Discovery (NDD) to identify early targets and novel compounds. Below, FENIX provides thoughts on this collaboration and Novo’s efforts to build its early stage pipeline. With this collaboration agreement, Novo will utilize e-Therapeutics to foster the ongoing research conducted in their recently inaugurated Novo Nordisk Research Center Oxford (previous FENIX insight). Although the financial terms of the collaboration were not……

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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CGM: Novel Non-invasive Platform Similar To Libre CGM Data

Today, Know Labs, a diagnostic solutions company evaluating the use of its Bio-RFID platform with non-invasive UBANDTM wearable (Fitbit like device) announced laboratory comparison test results of UBAND vs. Abbott FreeStyle Libre. Of note, the results demonstrated ~90% correlation to the Libre CGM data. The company previously announced the laboratory comparison test results of UBAND vs. Dexcom G5. Below, FENIX provides thoughts on non-invasive option for CGM.

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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Sanofi cuts ~670 jobs and adds 250 employees in France

It has been reported in a French article that Sanofi will cut up to 670 support function jobs in France by the end of 2020 on a voluntary basis and create an additional 250 jobs in bioproduction and digital segments. This decision is in line with Sanofi’s comments from September 2018 indicating plans to continue cost-cutting initiatives. Of note, Sanofi has cut ~5,000 of 25,000 jobs in France since 2008 and also laid off its US employees in the DCV BU (~ 20% of its global DCV BU staff) in December 2016. Recall, Sanofi also announced the restructuring of the global business units (GBUs) in September 2018……

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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New Mylan and Lilly trials: Ph3 biosimilar insulin aspart study, Ph2 URLi study in 670G

Last week, new Mylan and Lilly trials were observed on CT.gov. These include a Ph3 biosimilar insulin aspart study in T1DM by Mylan and a Ph2 URLi study by Lilly with Medtronic’s 670G closed-loop system. Below, FENIX provides thoughts on each of the respective studies. Mylan Ph3 Biosimilar Insulin Aspart Study in T1DM Mylan has initiated a Ph3 study for its biosimilar insulin aspart in T1DM with NovoLog as the comparator. This new trial is in-line with previous guidance from Mylan indicating the initiation of a Ph3 study in H2 ’18. Previously, it was anticipated that Mylan would initiate a 52-week Ph3 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.

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Purchase Blast$599.00

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Small Lantus Label Update

According to Drugs@FDA, the Lantus SoloStar label has been updated with changes in “Section 2.1 Dosage and Administration.” Below, FENIX provides additional details on the updated dosing instructions in comparison to the other marketed basal insulins. The updated label language (see excerpt below) includes the 1-unit dose dialing increments for the Lantus SoloStar pen. In addition to this change, a warning note has been added regarding audible clicks for visually impaired patients. Source: Lantus Solostar label from Drugs@FDA database The updated dosing instructions for unit dosage dialing and use in visually impaired patients seems to be consistent with other marketed……

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.

Nothing New in Sota Adcom Federal Register Announcement

Today, the FDA published a notice in the Federal Register announcing the sotagliflozin adcom for Jan 17, which was press released yesterday by Lexicon. No notable new details were provided, and the proposed indication is in-line with expectations as “…Adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.”

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.