Tag Archives: obesity

SELECT Doesn’t Stop at Interim Analysis; Novo Nordisk Q2 ’22 Earnings Update

Novo Nordisk hosted its Q2 ’22 earnings call (press release; slides), which was ahead of the initially scheduled call on August 4. Of note, management disclosed that following an interim analysis, the DMC recommended SELECT CVOT (view CT.gov record) should continue in accordance with the trial protocol. 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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New Non-invasive BGM; Amarin Updates Vascepa US Go-to-market Strategy; Welldoc Receives 510(k) Clearance for Bolus and Premixed Insulin Titration; CinFina Agreement with Janssen for QW Obesity Assets

A series of cardiometabolic-related news items have recently been observed: Know Labs announced the addition of KnowU, a portable Bio-RFID glucose monitoring device, to the company’s portfolio of non-invasive diagnostic technology; Amarin announced an update to its Vascepa go-to-market strategy, including US field force layoffs; Welldoc announced FDA 510(k) clearance for the BlueStar Insulin Adjustment Program for bolus and premixed insulin titration; and CinFina Pharma announced an agreement with Janssen Sciences Ireland Unlimited Company to acquire exclusive WW rights to four QW anorectic agents for the treatment fo obesity. 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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Novo Q2 ’21 Post-earnings Event

Novo Nordisk hosted its post-Q2 ’21 earnings event and provided further details on the obesity market and Wegovy launch. Below, FENIX provides an overview of the commentary from senior management beyond what was discussed during the Q2 ’21 earnings call as well as 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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AZ and Regeneron Collaborate on Obesity Treatment Development

AstraZeneca and Regeneron announced a collaboration for the research, development, and commercialization of small molecule compounds against the GPR75 gene to treat obesity and related comorbidities. For context, genetic mutations in GPR75 have been linked to patients having a lower BMI and experiencing a 54% lower risk of obesity than those without the mutation. According to the press release, AZ and Regeneron will evenly split the research and development costs as well as any future profits.

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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Wegovy Website Analysis

There have been no cardiometabolic press releases observed yet on the second day of ADA 2021. However, it appears that Novo Nordisk has recently launched the Wegovy patient website. Of note, the HCP website is not yet live as the wegovypro.com URL redirects to NovoMedLink. Below, FENIX provides an analysis of the Wegovy patient website and insights as to when to expect a DTC campaign 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

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Wegovy Label Analysis; Novo Investor Event Highlights

Today, Novo Nordisk hosted an investor call following its announcement late Friday (June 4) that FDA approved 2.4mg semaglutide, branded as “Wegovy,” for the treatment of obesity. The approval was based on results from the STEP Ph3a clinical trial program which demonstrated 17% weight loss after 104 weeks with 40% of patients losing ≥20 of their body weight after 104 weeks. Importantly, Novo intends to quickly launch Wegovy starting on June 10, 2021. Below, FENIX provides a Wegovy label analysis including thoughts on Novo’s decision to launch the product in five single-use autoinjector pens.

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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BI and Gubra Partner for Obesity Drug Development; Diabeloop DBLG1 Integrates with Accu-Chek Insight Pump; Tandem Appoints Jordan Pinsker as VP and Medical Director

A series of cardiometabolic-related news items have been observed: Boehringer Ingelheim and Gubra announced a research and licensing agreement for discovering and evaluating targets and innovative peptide compounds for the treatment of obesity; Diabeloop announced the integration of the Accu-Chek Insight insulin pump into the DBLG1 System; Tandem announced Jordan Pinsker from Sansum has been appointed as VP and Medical Director. 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

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Novo Files Sema 2.4mg Obesity Indication with FDA

Novo Nordisk announced it has filed the NDA for the semaglutide 2.4mg obesity indication. Recall, Novo disclosed in October 2020 that it would be using a PRV voucher, which reduces the review to 6 months. Below, FENIX provides thoughts on the anticipated approval timeline for sema 2.4mg and readthrough to Novo’s AM833 (amylin analog) development.

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 Invests in Early-Stage Glucose-Responsive Insulin Company; Novo Presents Full STEP 3 Results; Lifescan Hires New Head of Marketing; New CymaBay GPR119 Hypo Prevention Trial

A series of diabetes-related news items have been observed: Lilly invests in Protomer Technologies, a company developing novel drug therapies, including glucose-responsive insulin (view press release); Novo presents full data from the STEP 3 semaglutide obesity study at the 2020 Obesity Week conference (view press release); Lifescan hires Lisa Rose as the new Chief Marketing Officer (view press release); and CymaBay announced its GPR119 agonist will be evaluated in a T1DM hypo prevention study at Richard Pratley’s Translational Research Institute (view press release). 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 Reports Impressive AM833 Ph2 and AM833+sema Ph1 Topline Results

Novo Nordisk announced positive topline results for its Ph2 AM833 and Ph1 AM833+semaglutide trials, both for the treatment of obesity. Novo previously disclosed AM833 has been given the INN of “cagrilintide.” Recall, on June 12, 2020, Novo reported topline results from the final two trials in its Ph3 semaglutide obesity program (previous FENIX insight). Below, FENIX provides an overview of the topline data as well as brief thoughts on AM833 in the context of Novo’s injectable semaglutide Ph3 obesity program.

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.