Tag Archives: Viatris

Esperion Launches Website Featuring CLEAR Outcomes; Abbott Receives 510(k) Approval for APIs; Novartis Initiates Ph3 Inclisiran Primary Prevention Trial; Nemaura and Viatris Q4 ’22 Earnings Updates

Five cardiometabolic-related news items have been observed: Esperion announced it has launched a new website (esperionscience.com) featuring information about CLEAR Outcomes (view press release); Abbott received FDA 510(k) approval to add APIs to the FreeStyle Libre 2 and 3 CGM systems (view 510(k) decision letter); Novartis has initiated a Ph3 trial evaluating inclisiran vs. placebo in a primary prevention cohort (VICTORIAN-1 PREVENT; view CT.gov record); Nemaura Medical published its CY Q4 ‘22 (FY Q3 ‘23) business update (press release); and Viatris hosted its Q4 ’22 earnings call (press release; slides). 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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Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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.

JPM 2023 Day 3: ESPR, IONS, EMBC, AMRN, and VTRS

On the third day of JPM 2023, FENIX has provided coverage of presentations by other CVRM companies including Esperion, Ionis, Embecta, Amarin, and Viatris.

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 Completes Viatris Biosimilars Business Acquisition; Nemaura Launches Miboko Pilot Program in UK; BMS Terminates CV Partnership with uniQure

Three cardiometabolic-related news items have been observed: Biocon announced (view press release) the completed acquisition of Viatris’s biosimilar business (view press release); Nemaura announced the launch of its Miboko pilot program in the UK (view press release); and BMS reportedly terminated its research collaboration with uniQure (view article). Below, FENIX provides context and insight on the respective news items, including Nemaura’s challenged balance sheet.

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.

Lilly Connected Pen US Launch in 2022; Lannett Partners with Ypsomed; Eversense to Integrate with Apple; Viatris Q3 ’22 Earnings Update; November CHMP Agenda

A series of CVRM-related news items have been observed: Lilly announced plans to launch its Tempo Personalized Diabetes Management Platform to select US clinics in 2022; Lannett announced a partnership with Ypsomed for insulin pen delivery; Ascensia announced the Eversense implantable CGM now integrates with Apple Health; Viatris hosted its Q3 ’22 earnings and provided brief updates to its bs-insulin portfolio divestiture (press release; slides); and the November CHMP agenda (view here) has been released. 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.

Gan & Lee GZR4 IND Granted FDA Clearance; Viatris Q2 ’22 Earnings Update

Two cardiometabolic-related news items have been observed: Gan and Lee announced FDA accepted its IND application for a novel QW ultra-long-acting insulin (GZR4); and Viatris hosted its Q2 ’22 earnings call (press release; slides). 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 Recalls Another Batch of Glargine Vials; Intercept’s OCA Meets Primary Endpoint in New Interim Analysis; Dexcom partners with Zillion

Three cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of another batch of its unbranded insulin glargine U100 10mL vials due to a potential missing label (view FDA website); Intercept announced positive topline data from a new interim analysis from its ongoing Ph3 REGENERATE trial evaluating OCA in fibrosis due to NASH; and Zillion announced a partnership with Dexcom to integrate Dexcom’s CGM data with Zillion’s RestoreHealth program. 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.

Senseonics, Viatris, and Bayer Q1 ’22 Earnings Updates; Novo and Flagship Pioneering Collaboration; First Patient Dosed in Adocia Ph3 BC Lispro Trial

A series of cardiometabolic-related news items have been observed: Senseonics hosted its Q1 ‘22 earnings call (press release); Novo Nordisk announced a strategic collaboration with Flagship Pioneering for the development of novel research programs in cardiometabolic and rare diseases; Viatris (press release; slides) and Bayer (press release; slides) hosted their respective Q1 ’22 earnings calls; and Adocia announced the first patient has been dosed in its Ph3 BC Lispro program being conducted by partner Tonghua Dongbao (THDB). 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 Glargine Recalled; Carbon Health Launches Diabetes Management Program

Two cardiometabolic-related news items have been observed: Viatris announced a voluntary recall of one batch of its unbranded insulin glargine U100 10 mL vials due to a potential missing label; and Carbon Health announced the launch of its personalized diabetes management program. 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.

Lexicon Faces Another Sota Setback; Biocon to Acquire Viatris Biosimilars Business; Viatris Confirms Generic Ozempic Filing

A series of cardiometabolic-related news items have been observed: Lexicon announced it has withdrawn the sotagliflozin HF NDA; Lexicon hosted its Q4 and FY ’21 earnings call (press release); Biocon/Viatris announced Biocon will acquire the Viatris Biosimilars business; Viatris hosted an investor day and disclosed it has filed a generic Ozempic (press release; slides). 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.