Tag Archives: bs-aspart

Novo Settles Counterfeit Semaglutide Lawsuits; New Ph2 Oral GLP-1RA Study from Jiangsu Hengrui Pharmaceuticals; CSL Fails CSL112 Pivotal Trial; Eversense E3 CGM Medicare Coverage; Biocon CY Q4 ’23 (FY Q3 ’24) Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Jiangsu Hengrui Pharmaceuticals, CSL, Ascensia, and Biocon. 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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Novo’s FLOW Stops Early; Akero Misses in Ph2b NASH Study; Insulet Wins Preliminary Injunction Against EOFlow; Biocon Recieves Another CRL; Inpefa Receives Preferred Formulary Status with ESI; Carmot Oral GLP-1RA Ph1 Data

A series of cardiometabolic-related news items have been observed from Novo, Akero, Insulet, Biocon, Lexicon, and Carmot Therapeutics. Below, FENIX provides highlights and insights into the respective news items, including thoughts on the potential impact of Akero’s study results.

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.

Best Buy to Sell Dexcom G7; Gan & Lee Submits Bs-aspart and Bs-lispro MAAs; October CHMP Agenda; Tom Garner Joins Lexicon as SVP and CCO; Dario Partners with a Top Five Employee Benefits Consulting Firm; Senseonics and Ascensia Launch Eversense E3 Advertising Campaign

A series of cardiometabolic-related news items have been observed from BestBuy/Dexcom, Gan & Lee, EMA, Lexicon, Dario, and Senseonics/Ascensia. Below, FENIX provides highlights and insights into 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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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon Receives Even More Form 483 Observations; Roche and Alnylam Partner for Hypertension RNAi; Dario Issues Preliminary Q2 ’23 Results and Business Update

Three cardiometabolic-related news items have been observed: Biocon announced FDA conducted two cGMP inspections at Biocon’s insulin manufacturing facility in Malaysia and issued eight Form 483 observations (view press release); Roche and Alnylam announced a strategic agreement to co-develop and co-commercialize zilebesiran for the treatment of hypertension; and Dario announced a new agreement with an undisclosed large regional health plan as well as preliminary Q2 ’23 results (view press release). 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.

Wegovy Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

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 Partners with Life Edit Therapeutics; Biocon FY Q4 ’23 Earnings; Lilly initiates second trial in orforglipron obesity pivotal program; Mannkind appoints Burkhard Blank as EVP of R&D and CMO

A series of cardiometabolic-related news items have been observed: Novo Nordisk announced a partnership with Life Edit Therapeutics to develop gene-editing therapies for rare disorders and cardiometabolic disease (view press release); Biocon hosted its FY Q4 ‘23 (CY Q1 ‘23) earnings call (view press release); Lilly has initiated ATTAIN-2, the second trial in the company’s orforglipron pivotal obesity program (view CT.gov record); and Mannkind announced the appointment of Burkhard Blank as EVP of R&D and CMO (view press release). Below FENIX provides highlights and insights into 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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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon CY Q4 ’22 Earnings; Arrowhead Regains Rights to NASH Asset; Zydus Receives Tentative Approval for Generic Invokana

Three cardiometabolic-related news items have been observed: Biocon hosted its FY Q3 ’23 (CY Q4 ’22) earnings call (view press release) and disclosed plans to develop a generic tirzepatide; Arrowhead Pharmaceuticals announced it has regained rights to ARO-PNPLA3, formerly JNJ-75220795, which was being developed in collaboration with Janssen for the treatment of NASH (view press release); and FDA granted tentative approval for Zydus Pharmaceutical’s generic canagliflozin (Invokana; view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including brief thoughts on the potential timing of Biocon’s generic tirzepatide.

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.

Bydureon BCise US Pediatric Approval; Biocon FY Q1 ’22 (CY Q2 ’21) Earnings Update; Afrezza Pediatric Ph3 Trial Observed

A series of diabetes-related news items have recently been observed: AZ announced FDA approval of Bydureon BCise for patients 10-17 years of age with T2DM; Biocon hosted its FY Q1 ’22 (CY Q2 ’21) earnings call; and a CT.gov record has been observed for MannKind’s first Afrezza Ph3 pediatric study, called INHALE-1. 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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Purchase Blast$599.00

You can read the article’s full content online after purchase.

Mylan Filed for Glargine Interchangeability; Insulet, Mylan, and BD Q2 ’20 Earnings Updates

Mylan (press release; slides), Insulet (press release), and Becton Dickinson (press release; slides) hosted their respective Q2 ’20 earnings calls. Of note, Mylan disclosed it has submitted “all necessary documentation to seek biosimilar interchangeability [for Semglee]” as well as a BLA for its bs-aspart with FDA. Below, FENIX provides highlights and insights from the respective earnings calls.

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 Levels-up Insulin Strategy – Biocon CY Q2 ’20 Earnings Update

Biocon hosted its CY Q2 ’20 earnings call (FY Q1 ’21) and provided updates to the business including its biosimilar insulins portfolio (view press release). Of note, Biocon Biologics CEO Christiane Hamacher commented that the recent Voluntis “…digital therapeutic is not a nice to have, it’s a must-have.” Below, FENIX provides an updated perspective on the Biocon/Voluntis partnership, including thoughts on how the partnership may signal that Biocon could have altered its bs-insulin strategy.

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.