Tag Archives: Novo Nordisk

Novo Sues Teva Over Generic Saxenda; Cytokinetics Announces Disappointing METEORIC-HF Results; Zealand’s Pediatric Ph3 Dasiglucagon in CHI Trial Completes Enrollment

A series of cardiometabolic-related news items have been observed: It has been reported that Novo Nordisk has filed a suit against Teva regarding Teva’s recently filed generic version of Saxenda (view article); Cytokinetics announced topline results from the Ph3 METEORIC-HF trial which failed to demonstrate a benefit in exercise performance; and Zealand announced its Ph3 pediatric trial evaluating dasiglucagon in CHI has completed enrollment (view CT.gov record). 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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Novo Q4 ’21 London Earnings; Sanofi and Regeneron Q4 ‘21 and FY ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’21 earnings event (see previous FENIX insight on Q4 ’21 Novo earnings from February 2); and Sanofi (press release; slides; view infographic) and Regeneron (press release; slides), hosted their respective Q4 and FY ’21 earnings calls. 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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Purchase Blast$599.00

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Novo Q4 and FY ’21 Earnings Update

Novo Nordisk hosted its Q4 and FY ’21 earnings call (press release; slides) and provided updates across its commercial and pipeline activities, including the ongoing Wegovy supply shortage and a Rybelsus launch update. Of note, Novo disclosed it has been notified of four Paragraph IV ANDA filings for generic Ozempic. Additionally, Novo reminded about its upcoming 2022 Capital Markets Day on March 3, 2022. 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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Lilly Partners with Abbisko Therapeutics and Evotec; Novo Partners with EraCal Therapeutic; Fractyl Announces Initial Interim Feasibility Data

A series of cardiometabolic-related news items have been observed: Abbisko Therapeutics announced it has entered into a worldwide collaboration and exclusive licensing agreement with Lilly for the development of novel cardiometabolic therapies; Evotec announced a three-year drug discovery collaboration with Lilly for metabolic diseases focusing on kidney diseases and diabetes; EraCal Therapeutics announced a research collaboration with Novo Nordisk for development of anti-obesity pharmacotherapy; and Fractyl Health announced initial interim feasibility data from its open-label REVITA-T2Di trial. 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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Purchase Blast$599.00

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

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.

Novo Hosts Wegovy Shortage Call with Investors; Lannett Files Bs-glargine IND; Provention Adds New Management; Intercept NASH Data Delayed

A series of CVRM-related news items have been observed: Novo Nordisk hosted a call with investors to provide additional information and context on the recent announcement regarding its Wegovy supply constraints (view slides); Lannett announced it has filed an IND for its bs-glargine with the pivotal trial to begin in March 2022; Provention Bio announced it has expanded its executive team; and Intercept announced its Ph3 REVERSE trial topline data readout will be delayed to Q1 ’22. 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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Purchase Blast$599.00

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Novo Faces New Wegovy Supply Shortage

Novo Nordisk announced it is facing new Wegovy supply challenges in the US, and Novo will not be able to meet demand through H1 ’22. Novo said it will prioritize patients who have already initiated Wegovy treatment. According to the press release, the contract manufacturer has temporarily stopped deliveries and manufacturing due to “issues with Good Manufacturing Practices.” Novo plans to host a call with investors on December 20, 2021 to further discuss the Wegovy supply issue. Below, FENIX provides brief thoughts on the impact to the Wegovy launch.

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.

December 13-16 CHMP Agenda; Novo Invests Further in Kalundborg Manufacturing Facilities; CytoDyn Reports Additional Data from Ph2 Leronlimab NASH Trial; Adocia Files Patent for Oral Delivery Technology of Peptides

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (December 13-16) has been released, and Bayer’s finerenone is up for an opinion; Novo Nordisk announced an investment of DKK 17B (~$2.6B USD) into expanding its manufacturing facilities in Kalundborg, Denmark; CytoDyn announced additional preliminary results to date from the 20 patients who have completed the Ph2 open-label trial evaluating the impact of leronlimab on liver fibrosis associated with NASH; and Adocia announced it has filed a patent for an oral delivery technology. 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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Purchase Blast$599.00

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

Novo to Acquire Dicerna

Novo Nordisk and Dicerna Pharmaceuticals announced they have entered into a definitive agreement under which Novo will acquire Dicerna for $3.3B. The $3.3B total is equal to $38.25 per share in cash and a premium of 80% to Dicerna’s closing price on November 17, 2021. The transaction is expected to close in Q4 ’21. Below, FENIX provides thoughts on the acquisition, including insight into Novo’s potential motivations and the impact on Dicerna’s existing partners (e.g. Lilly and BI).

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’s High-Dose Ozempic Receives Positive CHMP Opinion; Movano Q3 ’21 Earnings Update

Two cardiometabolic-related news items have been observed: Novo Nordisk announced that its high-dose Ozempic (2.0mg semaglutide) has received a positive CHMP opinion and Movano hosted its Q3 ’21 earnings call (press release; view Movano website). 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.