Tag Archives: Viatris

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.

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Holiday Hangover: Novo Completes Dicerna Acquisition; FDA Approves Novartis’s Leqvio; Lexicon Submits NDA for Sotagliflozin; CMS Medicare Coverage Expansion Includes Non-adjunctive CGMs; Viatris Beats Sanofi’s Insulin-Pen Patent Invalidation Appeal; Beta Bionics iLet Bionic Pancreas Pivotal Trials Update

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Novartis, Lexicon, Medtronic, Viatris, and Beta Bionics. 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.

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.

November 8-11 CHMP Agenda; Kerendia+SGLT2i Reduce Risk of Composite CV Outcome; Viatris Q3 ’21 Earnings Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (November 8-11) has been released; Bayer announced positive results from an additional sub-analysis from the Ph3 FIDELITY trial demonstrating Kerendia (finerenone) in conjunction with SGLT2i reduced the risk of the composite CV outcome; and Viatris hosted its Q3 ’21 earnings call (press release; slides). Below, FENIX 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’s Semglee Gains Preferred Status on Prime Therapeutics’s National Formularies; Zealand’s First Patient Dosed with ZP8396 in Ph1 Trial for Obesity; Insulet, Lannett, Ionis, Provention Bio, BD, and Regeneron Q3 ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed from Prime Therapeutics, Zealand, Lannett, Ionis, Provention Bio, Becton Dickinson, Regeneron, and Dario. 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.

Viatris’ Semglee Preferred on Express Scripts NPF; DreaMed’s Advisor Pro Launched in Leading Children’s Hospital; MiniMed 780G & Guardian 3 TIR In Pediatrics Comparable to Adults; Abbott and Roche Q3 ’21 Earnings Updates; vTv Therapeutics Hires New President and CEO; Adhera Adds Target Indications for MLR-1023

A series of cardiometabolic-related news items have been observed from Viatris, DreaMed, Medtronic, Abbott, Roche, vTv Therapeutics, and Adhera Therapeutics. 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.

Viatris and Senseonics Q2 ’21 Earnings Updates; Forxiga CKD EU Approval; GoodRx and BI Patient Access Initiative; Diamyd EU Patent Granted; New Glooko CTO

A series of cardiometabolic-related news items have been observed: Viatris and Senseonics hosted their respective Q2 ’21 earnings calls; AstraZeneca announced EU approval of Forxiga for the treatment of CKD in adults with and without T2DM; GoodRx and BI announced an initiative to increase access to cost-savings programs for patients with T2DM and COPD; Diamyd announced the European Patent Office has granted the Diamyd’s recent patent application for treatment using GAD; and Glooko announced Prakash Menon has been appointed as the company’s Chief Technology Officer. 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.

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.

Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. 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.

Thoughts on Novo/Mylan (Viatris) Dismissing Their Victoza Patent Dispute; Did Viatris Just Abandon Its Generic?

On March 31, 2021, Novo Nordisk and Mylan (now Viatris) dismissed all claims from a US patent dispute over generic Victoza (view court documents). Recall, in August 2019, Novo filed a lawsuit against Mylan over Mylan’s ANDA Paragraph IV filing of a generic Victoza asserting that it was infringing upon 7 Novo patents. No further details regarding the agreement to dismiss the case were disclosed, and neither Novo nor Viatris has issued a press release. Below, FENIX provides thoughts on the litigation dismissal and how the evolving GLP-1RA market dynamics through 2025 could suggest Viatris will no longer pursue generic Victoza in the US.

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.