Category Archives: GLP-1RA

REWIND Receives Positive CHMP Opinion

Lilly announced that CHMP issued a positive opinion for a Trulicity CV indication based on results from the REWIND CVOT. Below, FENIX provides thoughts on the impending Trulicity EU label update as well as potential readthrough to the ongoing FDA regulatory review.

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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New Medtronic Professional CGM; One Drop/Bayer Partnership; EASD 2019 Key Press Releases (Sept 17)

On the second day of EASD, 7 key press releases and one new clinical trial were observed across diabetes drugs and devices. Below FENIX provides insights and context from each respective announcement.

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.

REWIND CHMP Opinion This Week?; Dapa/Saxa/Met Opinion Anticipated (CHMP Agenda Sept 16-20)

The CHMP agenda for this week’s meeting (September 16-20) has been released, and it includes two notable items (REWIND and dapa/saxa/met triple FDC opinions). Below, FENIX provides diabetes-related highlights and insights from the 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

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

Thoughts on Dance/Dario Partnership

Dance Biopharm and DarioHealth recently announced a partnership to integrate data from Dance’s smart inhaler into DarioHealth’s digital health management platform. Recall, Dance is developing inhalable insulin and GLP-1RA products. Below, FENIX provides thoughts on the partnership including context from MannKind similar partnership with OneDrop for the Afrezza BluHale platform.

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/Mylan Glargine CRL; BI/ZEAL Dual Agonist Moves to Ph2; Vertex Acquires Semma

Three key pieces of news have recently been observed: Biocon/Mylan received a CRL from FDA regarding their bs-glargine Malaysian manufacturing facility, Boehringer Ingelheim is advancing its dual agonist into Ph2 (licensed from Zealand), and Vertex entered into a definitive agreement to acquire Semma Therapeutics. Below, FENIX provides thoughts and insights on the respective news items including the uncertainty around Biocon/Mylan’s glargine in the context of the merger with Pfizer.

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.

More Thoughts from DAPA-HF… Could Novo+Lexicon Really Happen?

With the historic results of DAPA-HF recently presented at ESC 2019, FENIX provided some initial reaction. Today, FENIX continues to think about additional market possibilities and implications inside and outside SGLT2i dynamics in a winners-and-losers analysis format.

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 Sues Mylan Over Generic Victoza

Novo has filed a lawsuit against Mylan over Mylan’s ANDA Paragraph IV filing of a generic Victoza (view court documents here). In the complaint, Novo asserts that Mylan is infringing upon 7 Novo patents. Recall, during Novo’s Q2 ’19 earnings press release, Novo disclosed it received notice from Mylan regarding the generic Victoza ANDA filing but had not yet filed suit (previous FENIX insight). Below, FENIX provides brief thoughts on the Novo lawsuit including context from Novo’s recent settlement with Teva for its generic Victoza filing.

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.

Novo: Updated FENIX Viewpoint; Novo Q2 ’19 London Earnings Update

Novo Nordisk hosted its post-Q2 ’19 earnings event in London. Consistent with previous quarters, the session included a brief presentation from Novo management followed by Q&A. Below, FENIX provides highlights from the call including a scenario of reasonable likelihood around FENIX’s previous assertion questioning whether Novo is able to pursue accelerated approval for its anti-IL 21 + liraglutide T1DM beta cell preservation therapy. Additionally, FENIX includes an example of recent precedence set by FDA whereby FDA used an adcom to inform a regulatory decision about granting accelerated approval.

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: REDUCE-IT Adcom Readthrough to Oral Sema? MYL Generic Victoza Filed; Q2 ’19 Earnings Update

Novo Nordisk hosted its Q2 ’19 earnings call and provided updates to its diabetes business including the recent initiation of the first-in-human study of its novel basal insulin FSI965 as well as Ph2 completion of its anti-IL 21+liraglutide Ph2 trial in new-onset T1DM. Additionally, Novo disclosed that Mylan notified Novo of an ANDA Paragraph IV filing for generic Victoza. Below, FENIX provides highlights and insights from the call including potential readthrough from the recently scheduled Amarin REDUCE-IT adcom (and likely PDUFA delay) to the ongoing oral semaglutide FDA review.

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.

ADA Standards of Care Update: REWIND, CGM TIR Targets, and Victoza Peds

Yesterday, ADA announced updates to its Living Standards of Medical Care in Diabetes. The Living Standards of Care revision now incorporates REWIND CV data, Victoza use in pediatric patients, and the international consensus report on CGM time-in-range goals. Below, FENIX provides thoughts and market implications for each of the respective guideline updates.

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.