Category Archives: SGLT2i

Lexicon, Tandem, Amarin, Intercept, and Amgen Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lexicon (press release), Tandem (press release), Amarin (press release; slides), Intercept, (press release; slides), and Amgen (press release; slides), hosted their respective Q3 ’21 earnings calls. Importantly, Lexicon discussed its US sotagliflozin commercial strategy suggesting it is moving forward on its own. 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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Ionis Initiates New Ph3 Study in Hypertriglyceridemia; Real-World Evidence Study of PDT BT-001 for T2DM; Metacrine Announces MET409 Topline Results; Esperion and Pfizer Q3 ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Ionis announced the initiation of a second Ph3 clinical study (CORE) evaluating olezarsen in patients with severe hypertriglyceridemia; Better Therapeutics and Mass General Brigham announced a partnership for real-world evidence study evaluating the long-term effectiveness of Better Therapeutics’s BT-001; Metacrine announced topline results from the MET409 + empagliflozin Ph2a trial in patients with T2DM and NASH; and Esperion (press release; slides) and Pfizer (press release; slides) hosted their respective Q3 ’21 earnings calls. 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

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

Novartis’s Entresto Marketing Under DOJ Investigation?; Inventiva’s Ph2a Lanifibranor + Empa Trial (LEGEND); Merck and Sanofi Q3 ’21 Earnings Updates; Roche and Zur Rose Group Collaboration

A series of cardiometabolic-related news items have been observed: It has been reported that Novartis received a request from DOJ regarding details about the marketing and pricing of Entresto since 2016 (view article); Inventiva announced the design of its Ph2a combination (lanifibranor+empa) trial (LEGEND) in patients with NASH and T2DM; Merck (press release; slides) and Sanofi (press release; slides) hosted their respective Q3 ’21 earnings calls; and Roche and the Zur Rose Group announced their collaboration of healthcare products and solutions. 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.

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 and Novartis Q3 ’21 Earnings Updates

Today, Lilly (press release; slides) and Novartis (press release; slides) hosted their Q3 ’21 earnings calls. 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.

Forxiga Pediatric Indication and Generic Sitagliptin Receive Positive CHMP Opinions

Two cardiometabolic-related news items have been observed: AstraZeneca’s Forxiga received a positive CHMP opinion to include treatment of children aged 10 years and older with T2DM; and generic sitagliptin received a positive CHMP opinion. 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.

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.

vTv Therapeutics Announces Positive Results from TTP399 Mechanistic Trial; Non-Invasive CGM From Innovation Zed Advances

Two diabetes-related news items have been observed: vTv Therapeutics announced positive results of TTP399 mechanistic study in patients with T1DM; Innovation Zed announced research advancements for its non-invasive CGM project. Below, FENIX provides further 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.

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.

Jardiance HFpEF Indication Filed in EU; Generic Sitagliptin (EMEA/H/C/005741) CHMP Decision?; October 11-14 CHMP Agenda

The CHMP agenda for this month (October 11-14) has been released, and it includes two notable items, BI/Lilly has filed the Jardiance HFpEF indication and an opinion for generic sitagliptin (EMEA/H/C/005741) is up for adoption. Below, FENIX provides highlights and insights from the October 2021 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.

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.

BI/Lilly Launch Educational CVRM Game for HCPs; MannKind INHALE-1 Pediatric Study Enrolls First Patient; Dietitian-based Resource with PWD Launched

Three cardiometabolic-related news items have been observed: BI/Lilly announced the launch of an educational initiative for HCPs, called CRMSynced, which uses gamification to encourage HCPs to prioritize a holistic approach to disease management; MannKind announced the first patient has been enrolled in the Afrezza Ph3 pediatric study; Teatis announced the launch of Teatis RD on Demand, a resource designed to connect people with diabetes to dietitians who can assist in managing their disease through personalized meal plans. 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.

September 13-16 CHMP Agenda; Dexcom Exec Joins iRhythm as CEO; Provention Teplizumab Update

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month (September 13-16) has been released; iRhythm announced Quentin Blackford, outgoing Dexcom COO, will join the company as President and CEO, effective October 4, 2021; and Provention Bio issued an update on the BLA resubmission of teplizumab to delay the onset of T1DM in at-risk individuals (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.

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.

Jardiance Receives Breakthrough Therapy Designation for HFpEF; Metacrine Ph2a NASH Trial Completes Enrollment; Dario Signs Northeast Regional Employer

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA granted Breakthrough Therapy Designation (BTD) to Jardiance for the treatment of HFpEF; Metacrine announced the Ph2a trial evaluating MET642 in 180 patients with NASH has completed enrollment; and Dario Health announced it was selected as the digital health provider for a Northeast regional employer. 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.

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.