Tag Archives: Mylan

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.

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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.

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Biocon/Mylan Bs-Aspart and Xeris Glucagon up for CHMP Opinions? CHMP Agenda December 7-10

The CHMP agenda for this month (December 7-10) has been released, and it includes two notable items, potential CHMP opinions for Biocon/Mylan’s insulin aspart and Xeris’s glucagon, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the December 2020 CHMP agenda.

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

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Novo to Acquire Emisphere Technologies; Mylan Q3 ’20 Earnings Update

Two diabetes-related news items have been observed: Emisphere Technologies announced it is being acquired by Novo Nordisk for $1.35B ($7.82/share) and Mylan announced its Q3 ’20 earnings update. Below, FENIX provides thoughts on Novo’s acquisition of Emisphere and potential catalysts behind the acquisition, including oral peptide delivery development beyond semaglutide.

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

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Biocon/Mylan Launch Semglee in US at 65% WAC Discount to Lantus

Biocon/Mylan announced the US launch of its Semglee 10mL vials and pre-filled pens (glargine U100) at a 65% discount to Lantus. According to Biocon/Mylan, the WAC for a package of 5 x 3mL pens is $147.98 and a 10mL vial is $98.65. Interestingly, Biocon/Mylan said the Semglee pen price matches the Lantus 2007 WAC and the Semglee vial list price matches the Lantus 2010 price. Below, FENIX provides a comparative pricing analysis across the basal insulin market, the Semglee launch implications to Sanofi and Lilly, and thoughts on how the Biocon/Mylan strategy may impact other bs-glargine manufacturers (e.g. Sandoz/G&L and Lannett/HEC).

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

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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.

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Biocon/Mylan Bs-glargine Approved; Novo to Acquire Corvidia; Lifescan Launches Verio Reflect; Lannett FDA Bs-glargine Meeting; Medtronic 780G CE Mark; Dexcom Launches G6 Pro; ADA ’20 Key Data and Partnership Press Releases (June 11)

Ahead of the ADA 2020 conference start, a series of diabetes-related press releases have been observed: Biocon/Mylan received FDA approval for its bs-glargine, Novo Nordisk is set to acquire Corvidia, Lannett provided an update on its meeting with FDA for bs-glargine, LifeScan launched the Verio Reflect BGM, Medtronic received CE Mark for the 780G system, Dexcom launches G6 Pro, and DarioHealth entered into new partnership agreements. Below, FENIX provides context and analysis for the 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.

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Purchase Blast$599.00

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Mylan Wins Final Patent Dispute vs. Sanofi; Biocon Bs-glargine Final FDA Approval Imminent

Mylan announced the US Patent and Trademark Appeal Board (PTAB) ruled in Mylan’s favor during recent inter partes review (IPR) proceedings. Importantly, Mylan’s outgoing CEO, Heather Bresch, commented, “…with this final victory in hand, we now look forward to working with FDA to complete the regulatory review process and introduce Semglee in the U.S. as soon as possible.” Recall, Mylan/Biocon has disclosed that the FDA action date for their bs-glargine is sometime in June 2020. Below, FENIX provides a brief overview of the PTAB ruling as well as thoughts on the impending approval and launch of the Mylan/Biocon bs-glargine product.

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

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Mylan Q4 ’19 Earnings Update; Bs-glargine Briefly Discussed

Mylan hosted its Q4 and FY 2019 earnings call and provided updates to its business. The vast majority of the call revolved around the pending merger with Pfizer’s Upjohn. Of note, Mylan briefly discussed the US regulatory status of its bs-glargine and bs-aspart (in partnership with Biocon). Below, FENIX provides highlights and insights from the call.

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

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Biocon Insulin Manufacturing Facility Fails Another FDA Inspection

Biocon issued a press release stating it received a Form 483 with three observations following an FDA inspection (Feb 10-21) of its Malaysian manufacturing facility. The deficiencies were noted by FDA during the pre-approval inspection for the company’s biosimilar glargine. Recall, during Biocon’s recent earnings call, Biocon disclosed FDA has set an action date in June 2020. Below, FENIX provides brief thoughts on the failed inspection and how it could impact US commercialization of its bs-glargine product.

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.