Category Archives: Basal Insulin

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.

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.

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.

Novo QW Insulin Icodec Ph2 Data; Lilly Pump Feasibility Data; New Dasiglucagon Data; January.ai Glucose Prediction Algorithm; Key Press Releases (June 14)

Today, four diabetes-related news items were observed: Novo presented Ph2 QW insulin icodec data in T2DM, Lilly presented feasibility data for its automated insulin delivery system, Zealand presented additional dasiglucagon data (including pediatrics), and January.ai showcased its new glucose prediction algorithm. 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.

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.

Welldoc Insulin Adjustment Program Approved by FDA; Fractyl to Initiate Study for Insulin-dependent T2DM Patients

Two diabetes-related news items have been observed: Welldoc announced FDA approval of an additional feature for the BlueStar platform called the Insulin Adjustment Program (IAP) and Fractyl Laboratories announced FDA approval of an Investigational Device Exemption (IDE) to initiate a study examining the effects of Revita DMR in T2DM patients treated with insulin. 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.

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.

Mylan Wins Final Patent Dispute vs. Sanofi; Biocon Bs-glargine Final FDA Approval Imminent

Mylan announced the US Patent and Trademark Appeal Board (PTAB) ruled in Mylan’s favor during recent inter partes review (IPR) proceedings. Importantly, Mylan’s outgoing CEO, Heather Bresch, commented, “…with this final victory in hand, we now look forward to working with FDA to complete the regulatory review process and introduce Semglee in the U.S. as soon as possible.” Recall, Mylan/Biocon has disclosed that the FDA action date for their bs-glargine is sometime in June 2020. Below, FENIX provides a brief overview of the PTAB ruling as well as thoughts on the impending approval and launch of the Mylan/Biocon 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.

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.

Biocon Q1 ’20 (FY ’20) Earnings Update

Biocon hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and provided brief updates on its biosimilar insulin development programs. Unsurprisingly, there were many analyst questions focusing on pricing strategy and interchangeability for bs-glargine, although Biocon’s senior management were reluctant to provide details. Below, FENIX provides highlights from the earnings call as well as brief thoughts on what approval for interchangeability in the US may look like.

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.

Updated Perspective on Nemaura’s CGM; Lifescan and Noom Collaboration; Dario Q1 ’20 Earnings Update

Several diabetes-related news items have been observed: Nemaura Medical’s CEO provided an interview regarding the company’s H2H CGM study, saying that the CGM used was Abbott’s Libre, Lifescan announced a partnership with Noom to pilot a digital diabetes and weight loss management program, and DarioHealth hosted its Q1 ’20 earnings call. Below, FENIX provides updated perspective on Nemaura’s CGM in light of the recent CEO interview, thoughts on the Lifescan/Noom collaboration, and highlights from the Dario earnings 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.