Tag Archives: BIOCON

Viatris Recalls One Batch of Non-interchangeable Semglee Prefilled Pens; Dario Hosts 2022 Investor Webinar

Two cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of one Semglee batch due to a potential missing label (view FDA website); and Dario hosted its 2022 Investor Webinar (view presentation replay) to discuss emerging digital health trends for strategic growth in 2022. Below, FENIX provides highlights and insights for the respective new 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.

Viatris/Biocon Launch Interchangeable Semglee in US; Lexicon Presents SOLOIST/SCORED Renal Subcuts at AHA; CRISPR/ViaCyte to Initiate Ph1 Trial in T1DM; Innovation Zed Announces InsulCheck DOSE 2022 Launch; Nemaura and Dario Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Viatris/Biocon, Lexicon, CRISPR Therapeutics/ViaCyte, Innovation Zed, Nemaura Medical, and Dario Health. 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.

Novo Raises 2021 Guidance; Novo’s “Bigger Than Me” Anti-Obesity Awareness Campaign; Biocon’s Form 483 Observations Revealed; Novel Human Neo-Islet Technology Published

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it has raised its 2021 guidance ahead of the Q3 ’21 earnings release on November 3; Novo has initiated an unbranded “Bigger Than Me” campaign for anti-obesity awareness featuring Queen Latifah (view article); It has been reported that details from the Form 483 observations made in FDA’s September 2021 pre-approval inspection of Biocon’s Malaysian facility were released to the public (view article); and SymbioCellTech announced pre-clinical data for its Neo-Islets technology have been published in PLOS ONE. 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.

Metacrine Discontinues NASH Program; Ikenna Ogbaa Joins GSK to Lead Daprodustat Medical Team; Biocon CY Q3 ’21 (FY Q2 ’22) Earnings Update; Integrity Applications Hires New President and COO

A series of cardiometabolic-related news items have been observed: Metcarine announced it is discontinuing its NASH FXR development program following Ph2a interim results; Ikenna Ogbaa, MD joins GSK to lead daprodustat US medical affairs (view LinkedIn profile); Biocon hosted its Q3 ’21 (FY Q2 ’22) earnings call (press release); and Integrity Applications announced Dr. Paul V. Goode (view LinkedIn) will join the company as the new President and COO. 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.

Nemaura Launches New Metabolic Health Program; Biocon Receives More Form 483 Observations; Virta Health Key Leadership Appointments; Dexcom G6 Coverage in Manitoba; EASD 2021 Key Press Releases (Sept 29)

On the third day of EASD 2021, four key press releases were observed from Nemaura, Biocon, Virta Health, and Dexcom. Below FENIX provides insights and context for the respective 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.

Semglee (Bs-glargine) Receives US Interchangeability; Sanofi Q2 ’21 Earnings Update

Two diabetes-related news items have been observed: Viatris and Biocon announced FDA approval of Semglee (bs-glargine) as the first interchangeable biosimilar insulin product under the 351(k) regulatory pathway; and Sanofi hosted its Q2 ’21 earnings call and provided a brief update to its diabetes business. 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.

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.

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.

Dexcom, Teladoc, Amarin, Biocon, and Merck Q1 ’21 Earnings Updates; Abbott Libre 3 User Reviews

Six cardiometabolic-related news items have recently been observed from Dexcom, Abbott, Teladoc, Amarin, Biocon, and Merck. 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.

Biocon/Viatris Bs-aspart and Xeris RTU Glucagon Receive EC Approval; Poxel Q4 and FY ’20 Earnings Update

A series of cardiometabolic-related news items have been observed: Biocon/Viatris announced EC approval for their rapid-acting bs-insulin aspart, branded as Kixelle; Xeris announced it received EC approval for its RTU rescue glucagon product, branded as Ogluo; and Poxel announced its Q4 and FY ’20 earnings. 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.

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.