Tag Archives: Diabetes

Will AZ Fund an Additional Roxa Trial?; Senseonics Eversense E3 CGM Receives FDA Approval

Two cardiometabolic-related news items have been observed: AZ’s Executive VP and head of biopharmaceuticals R&D conducted an interview and commented on the likelihood of performing another roxadustat trial to address the FDA CRL (view article); and Senseonics announced its Eversense E3 CGM (180-day sensor) has received FDA approval. 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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Dexcom Q4 ‘21 and FY ‘21 Earnings Update

Dexcom hosted its Q4 ’21 earnings call (press release; slides) and provided updates to its clinical and commercial activities, including the anticipated G7 OUS and US launches throughout 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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AZ Q4 ’21 and FY ’21 Earnings Update

AstraZeneca hosted its Q4 ’21 earnings call (press release; slides). Much of the prepared remarks and Q&A focused on the company’s COVID-19 vaccine development, recent Alexion acquisition, and oncology portfolio. The cardiometabolic-related discussion primarily highlighted AZ’s pipeline initiatives in HF and CKD. Of note, AZ did not provide any commentary regarding Roxadustat during the call; however, FENIX will be covering the upcoming FibroGen earnings call anticipated to be held on March 1, 2022. Key points from the AZ Q4 ’21 earnings call are listed below.

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.

Did Lilly Purchase BioMarin’s PRV?; Rivus Announces Positive Ph2a HU6 Trial Results; Second Sight to Merge with Nano Precision for GLP-1RA Implantable

Three cardiometabolic-related news items have been observed: BioMarin announced it sold a PRV for $110M but did not disclose the buyer; Rivus Pharmaceuticals announced positive results from its Ph2a HU6 trial; and Second Sight Medical Products and Nano Precision Medical (NPM) announced that they have entered into a definitive merger agreement. Below, FENIX provides highlights and insights for the respective new items, including thoughts on why Lilly may have been the company to purchase BioMarin’s PRV.

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.

Amgen Business Review Meeting and FY ’21 Earnings; Pfizer Q4 ’21 Earnings

Two cardiometabolic-related news items have been observed: Amgen hosted a Business Review Meeting (press release; slides) and released its Q4 ’21 and FY ’21 earnings (press release); and Pfizer hosted its Q4 ’21 and FY ’21 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.

Diamyd to Initiate Ph3 DIAGNODE-3 Trial in Europe; First Patient Dosed with CRISPR and ViaCyte’s VCTX210 in Ph1 Trial; Know Labs Bio-RFID Device Receives IRB Approval

A series of cardiometabolic-related news items have been observed: Diamyd Medical announced it will proceed to initiate its Ph3 T1DM vaccine trial (DIAGNODE-3) in Europe; CRISPR and ViaCyte announced they have dosed the first patient in their Ph1 VCTX210 trial; and Know Labs recently announced that it received IRB approval for a new trial of its non-invasive glucose monitor. 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.

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.

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.

Lannett, Merck, Roche, and BD Q4 ‘21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lannett (press release), Merck (press release; slides), Roche (press release; slides), and BD (press release; slides) hosted their respective Q4 ’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.

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 Q4 ‘21 and FY ‘21 Earnings Update

Lilly hosted its Q4 ’21 earnings call (press release; slides) and provided updates across its CVRM portfolio with a particular focus on tirzepatide. Of note, Lilly did not discuss its CVRM pipeline assets including its QW insulin (basal insulin Fc) which is scheduled to enter Ph3 this year. Below are 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.

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.

Novartis Q4 and FY ’21 Earnings Update

Novartis hosted its Q4 ’21 earnings call (press release; slides) and provided brief updates to its CVRM business, including Entresto’s market performance and updates on Leqvio’s US and UK launches. Although not discussed in detail, management stated clinical trials for both iptacopan and pelacarsen remain on track. Additionally, management stated that the Sandoz strategic review remains in progress and Novartis will “hopefully come to a decision” in H2 ’22. Below are highlights 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.

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.