Category Archives: Topics

Adocia Reports Positive BC Lispro Data with Tonghua Dongbao Insulin; January 25-29 CHMP Agenda

A series of cardiometabolic-related news items have been observed: Adocia announced positive results from a BioChaperone Lispro trial using insulin sourced from Tonghua Dongbao; and the CHMP agenda for this month’s meeting (January 25-29, 2021) has been released, and it includes one notable item: EMPEROR-Reduced is on the CHMP agenda but not believed to be up for an opinion. Below, FENIX provides highlights and insights from 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 Diabetes/COVID-19 Publication in JDST

The Diabetes Technology Society announced the publication of a report titled, “How to Best Protect People With Diabetes From the Impact of SARS-CoV-2: Report of the International COVID-19 and Diabetes Summit” in the Journal of Diabetes Science and Technology. The report is a summary of the Virtual International COVID-19 and Diabetes Summit, which was held on August 26-27, 2020, and included 79 speakers from NIH, CDC, ADA, HCPs, and manufacturers.

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 CY Q4 ’20 (FY Q3 ’21) Earnings Update; Biocon Biologics CEO Resigns

Biocon hosted its CY Q4 ’20 (FY Q3 ’21) earnings call and provided updates on its biosimilar insulin portfolio. Importantly, Biocon disclosed that Christiane Hamacher, the CEO of Biocon Biologics, has resigned “due to professional differences with the chairperson on strategic priorities and vision for the company.” Below, FENIX provides highlights and insights from the call relating to the corporate restructuring and Biocon’s bs-insulin portfolio.

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 Randomizes First Patients in Ph3 Oral Insulin Trial; Dario Hires New Employer Sales Lead

Two diabetes-related news items have been observed: Oramed has begun randomizing patients into its Ph3 ORMD-0801 T2DM study (view press release) and Dario announced the hiring of Chris Chan as the company’s new SVP of employer sales (view press release). Below, FENIX provides highlights and insights from 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.

Verquvo (Vericiguat) Approved by FDA; Label Analysis, Entresto and CYTK Implications

Merck and Bayer received FDA approval of vericiguat, branded as “Verquvo,” for symptomatic chronic HF (Merck press release here and Bayer press release here). Recall, vericiguat received Priority Review from FDA in July 2020 despite the modest 10% RRR in the VICTORIA CVOT primary endpoint (view NEJM publication). For context, Verquvo is the first treatment for chronic HF approved specifically for patients following a hHF or need for outpatient intravenous diuretics. Below, FENIX details its Verquvo label analysis, including the potential for counter-detail by SGLT2i manufacturers, as well as thoughts on the cumulative regulatory tailwinds for Cytokinetics’s omecamtiv.

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 Ozempic Filed with FDA; Andy Ajello Joins Vifor

Novo Nordisk announced it has filed the sNDA for high-dose Ozempic (2.0mg) based on results from the SUSTAIN FORTE trial, which read out in November 2020 (previous FENIX insight). Additionally, Andrew (Andy) Ajello, former Lexicon Commercial Lead and Novo SVP of  US Diabetes/Obesity Sales, has joined Vifor Pharma as the VP of US sales (view LinkedIn profile). Below, FENIX provides thoughts and insights on 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.

Metacrine NASH Fast Track Designation; Senseonics Receives Positive Coverage Decision for EmblemHealth; Insulet Launches Omnipod DASH in Canada

A series of cardiometabolic-related news items have been observed: Metacrine announced FDA granted Fast Track designation to MET642 for the treatment of NASH; Senseonics announced a positive coverage decision for its implantable CGM from EmblemHealth; and yesterday, Insulet announced the Canadian launch of Omnipod DASH. 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.

JPM 2021 Day 4: Lexicon Poised for a Strong Comeback; Lexicon, Viatris, and Intercept @ JPM; Poxel/Metavant Partnership Terminated

On the final day of JPM 2021, FENIX has provided coverage of presentations by cardiometabolic companies including Lexicon, Viatris, and Intercept. Additionally, two separate cardiometabolic-related news items have been observed: Lexicon announced it received FDA feedback stating SOLOIST and SCORED results support a sotagliflozin NDA submission for a broad HF indication; and Poxel/Metavant announced the termination of their partnership. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage, including Lexicon’s proposed broad HF label for sotagliflozin and Viatris’s biosimilar Toujeo.

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.

JPM 2021 Day 3: Bayer, Esperion, Precision Bio, Hikma, Vifor; High-dose Oral Sema PIONEER PLUS Trial Posted on CT.gov; Dario Announces Two New Additions to Scientific Advisory Board

On day three of JPM 2021, FENIX has provided coverage of presentations from Bayer, Esperion, Precision Biosciences, Hikma, and Vifor. Additionally, two separate cardiometabolic-related news items have been observed: a CT.gov record has been observed for Novo Nordisk’s PIONEER PLUS trial investigating high-dose oral semaglutide in people with T2DM; and DarioHealth announced Marilyn Ritholz and David Horwitz will be joining the Scientific Advisory Board. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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.

JPM 2021 Day 2: LLY, NVO, ABT, PODD, AMRN, and IONS; Bayer’s Finerenone Receives Priority Review for DKD

On day two of JPM 2021, FENIX has provided coverage of presentations by Lilly, Novo Nordisk, Abbott, Insulet, Amarin, and Ionis. Additionally, one separate cardiometabolic-related news item has been observed: Bayer announced FDA granted priority review of finerenone for patients with DKD. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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.