Category Archives: Topics

Insulet Initiates Omnipod 5 US Broad Launch; Arecor Buys Tetris Pharma; Sanofi/Optum Partner for Insulin Affordability

A series of diabetes-related news items have been observed: Insulet announced the full market release of its Omnipod 5 hybrid closed-loop system; Arecor is acquiring Tetris Pharma who is partnered with Xeris for UK/EU/CH Ogluo commercialization (view Xeris press release); and Sanofi/Optum have partnered to reduce the cost of insulin to uninsured patients (press release). Below, FENIX provides context and insight on 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’s QW Insulin Icodec Meets Primary Endpoints in ONWARDS 3 and 4; AZ and Alnylam Q2 ’22 earnings updates; Better Therapeutics Meets Secondary Endpoint in BT-001 Pivotal Trial in T2DM

A series of cardiometabolic-related news items have been observed: Novo announced topline results from the QW insulin icodec Ph3 ONWARDS 3 and ONWARDS 4 trials in T2DM; AZ (press release; slides) and Alnylam (press release; slides) hosted their respective earnings calls; and Better Therapeutics (BT) announced positive secondary endpoint results for its BT-001 pivotal clinical trial in T2DM and held an associated investor call (view webcast). 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.

Dexcom G7 Delayed in US; Dexcom, Pfizer, Biocon, Sanofi, and Teladoc Q2 ’22 Earnings Updates

A series of cardiometabolic-related news items have been observed: Dexcom (press release; slides), Pfizer (press release; slides), Biocon (press release), Sanofi (press release; slides), and Teladoc (press release; slides) hosted their respective Q2 ’22 earnings calls. Importantly, Dexcom disclosed the G7 FDA review has been delayed due to updates needed for the app. Below, FENIX provides highlights and insights from the respective earnings calls.

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.

Lexicon’s Sota HF NDA Accepted by FDA in Patients With and Without T2DM

Lexicon announced FDA accepted the sotagliflozin HF NDA with a PDUFA date in May 2023. Importantly, Lexicon disclosed the filed indication includes a broad patient population for those with and without T2DM despite the SCORED and SOLOIST trials being conducted in patients with T2DM. Recall, Lexicon resubmitted the sota NDA in May 2022 after a voluntary NDA withdrawal in February 2022 due to an unintentional exclusion of supportive documents (previous FENIX insight). Below, FENIX provides brief thoughts on the sota standard review, including a potential savvy maneuver by Lexicon.

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 Receives $10M Investment from CinPax, LLC; Oramed Reaches 50% Enrollment in Second Ph3 Oral Insulin Trial; Esperion Establishes Scientific Advisory Board

Three cardiometabolic-related news items have been observed: vTv announced it received a $10M investment from CinPax; Oramed announced it has reached over 50% enrollment in its second Ph3 oral insulin trial in T2DM; and Esperion established a Scientific Advisory Board to support pipeline and LCM initiatives. 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.

Tandem Acquires Capillary Biomedical; Lilly’s Mounjaro Receives Positive CHMP Opinion

Two cardiometabolic-related news items have been observed: Tandem announced it has acquired Capillary Biomedical; and EMA announced Mounjaro (tirzepatide) received a positive CHMP opinion for the treatment of T2DM in adults. 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.

Abbott Q2 ’22 Earnings Update; Lilly to Initiate Fourth Trial in Ph3 QWINT Program; Ionis’s Ph3 Lp(a) HORIZON CVOT Completes Enrollment

Three cardiometabolic-related news items have been observed: Abbott hosted its Q2 ’22 earnings call (press release; view infographic); a fourth trial from Lilly’s Ph3 QW insulin program has been observed (view CT.gov record); and Ionis announced that the Ph3 Lp(a) HORIZON CVOT evaluating 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.

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 and J&J Q2 ’22 Earnings Updates

Two cardiometabolic-related news items have been observed: Novartis (press release; slides) and J&J (press release; slides) hosted their respective Q2 ’22 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.

Tirzepatide up for CHMP Opinion; July 18-21 CHMP Agenda; Lilly Initiates QW Insulin T2DM MDI Trial (QWINT-4); UHC Eliminates Insulin OOP Costs

A series of cardiometabolic-related news items have been observed: the CHMP agenda for this month’s meeting (July 18-21) has been released and it appears Lilly’s tirzepatide is up for an opinion; a third trial from Lilly’s Ph3 QW insulin program (BIF; LY3209590) has been observed (view CT.gov record); and UnitedHealthcare announced that starting January 1, 2023, it will eliminate out-of-pocket costs for certain preferred prescription drugs, including insulin and four medical emergency drugs. 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.

Abbott Progresses Libre 3 US Launch; New Trial Dasiglucagon Trial for Inreda’s Bi-hormonal AID system; NICE Recommends Amarin’s Vazkepa for Reimbursement in England and Wales

Three cardiometabolic-related news items have been observed: Abbott has recently posted a series of eight new instructional videos on its FreeStyle US YouTube channel (view YouTube Channel) for the Libre 3 CGM; an Inreda-sponsored study has been observed evaluating the feasibility of Zealand’s dasiglucagon in its bi-hormonal closed-loop system (STABLE-1; view CT.gov record); and Amarin announced NICE issued final guidance recommending reimbursement for Vazkepa (icosapent ethyl) in England and Wales. 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.