Category Archives: Topics

Lilly to Divest Baqsimi to Amphastar; Medtronic 780G+GS4 FDA Approval; April CHMP Agenda

Three cardiometabolic-related news items have been observed: Lilly announced it entered into a definitive agreement with Amphastar Pharmaceuticals to divest Baqsimi worldwide rights (view press release); Medtronic’s MiniMed 780G system with the Guardian Sensor 4 (GS4) has received FDA approval (view press release); and the CHMP agenda (view here) for this month’s meeting (April 24-26) has been released. Below, FENIX provides highlights and insights into the respective news items including insight into Lilly’s potential strategy behind the Baqsimi move.

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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Lilly Initiates SURMOUNT H2H Obesity Trial vs. Wegovy; Lannett Delisted from NYSE; Novo Initiates Ph3 Icodec ONWARDS 9 CGM Trial; Senate Targets PBMs

A series of cardiometabolic-related news items have been observed: Lilly has initiated a fifth trial in the Ph3 SURMOUNT obesity program evaluating tirzepatide vs. Wegovy in non-T2DM obese patients (SURMOUNT-5; view CT.gov record); Lannett announced NYSE has commenced proceedings to delist its common stock (view press release); Novo Nordisk has initiated a Ph3 trial evaluating flash glucose monitoring based titration of QW insulin icodec in insulin-naïve T2DM participants (ONWARDS 9; view CT.gov record); the Senate Finance Committee has released a framework to target PBMs and reduce drug costs for patients and taxpayers (view here); and Senator Bernie Sanders’s team announced that the Senate Health, Education, Labor, and Pensions (HELP) Committee will hold a hearing on Wednesday, May 10, at 1:00 PM EST where the CEOs of Lilly, Novo, Sanofi, and senior executives from major PBMs will testify (view article). Below, FENIX provides highlights and insights into 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.

Abbott Q1 ’23 Earnings; Eversense 365-Day Sensor Inserted Into First Pediatric Patient; Esperion Partners With Currax for Nexletol/Nexlizet Promotion; Zucara ZT-01 Ph2 T1DM IND Cleared

Four cardiometabolic-related news items have been observed: Abbott hosted its Q1 ’23 earnings call (view press release; infographic); Senseonics announced the Eversense 365-day sensor has been inserted into the first pediatric patient as part of the ENHANCE clinical trial (view press release); Esperion announced a co-promotion agreement with Currax for Nexletol and Nexlizet (view press release); and Zucara Therapeutics announced FDA has cleared the ZT-01 IND application for the prevention of nocturnal hypoglycemia in patients with T1DM (view press release). Below, FENIX provides highlights and insights into 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.

Resmetirom Receives Breakthrough Therapy Designation; Tiziana Initiates Foralumab T1DM Program; Teladoc Expands Provider-Based Care; J&J Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Madrigal announced resmetirom received Breakthrough Therapy Designation (BTD) from FDA for the treatment of NASH with liver fibrosis (view press release); Tiziana Life Sciences announced it is initiating a program to develop intranasal foralumab for the treatment or prevention of T1DM (view press release); Teladoc Health announced the expansion of its Provider-Based Care for weight management and prediabetes programs (view press release); and Johnson & Johnson hosted its Q1 ’23 earnings call (press release; slides). Below, FENIX provides highlights and insights into 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 Invests $1.6B in Indiana Manufacturing; Dexcom and Abbott Highlight Medicare CGM Coverage Expansion; Tandem Announces Positive Control-IQ Meta-Analysis

Three cardiometabolic-related news items have been observed: Lilly announced that it will invest an additional $1.6B and add another 200 jobs to its new manufacturing sites within LEAP Innovation Park in Boone County, Indiana (view press release); Dexcom (view press release) and Abbott (view press release) separately issued statements regarding CMS’s decision to expand Medicare coverage for T2DM, including certain non-insulin-using individuals; and Tandem Diabetes announced that Diabetes Technology & Therapeutics published a meta-analysis of three Control-IQ AID trials (view press release; publication). Below, FENIX provides highlights and insights into 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.

Lilly Completes SURMOUNT-2 Trial; FDA Clears Libre 3 Reader; Novo Initiates Ph3 Icodec + Semaglutide Treatment Intensification Trial

Three cardiometabolic-related news items have been observed: On April 13, 2023, the ClinicalTrials.gov record for SURMOUNT-2 was updated to reflect that the trial has been completed; Abbott announced FDA cleared a standalone reader for its FreeStyle Libre 3 iCGM system (view press release); and Novo Nordisk has initiated a Ph3 T2DM trial evaluating icodec as add-on therapy to semaglutide for treatment intensification (view CT.gov record). Below, FENIX provides highlights and insights into 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.

Novo Raises 2023 Guidance; Sana Biotechnology Appoints New R&D Leaders and Announces Publication of Pre-Clinical Data

Two cardiometabolic-related news items have been observed: Novo Nordisk announced its full-year sales and operating profit outlook has been raised for 2023 (view press release); and Sana Biotechnology announced the appointment of Douglas E. Williams, as President of R&D, and Gary Meininger, MD, as CMO, of its R&D organization (view press release). Separately, Sana announced the publication of pre-clinical data for its hypoimmune pancreatic islet cells in Science and Translational Medicine (view press release). Below, FENIX provides highlights and insights into 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.

New Tirzepatide Injection Device Trial; Novo Partners with Aspect Biosystems; Sanofi’s Provention Bio Acquisition Regulatory Issue; Glooko Partners with Hedia

Four cardiometabolic-related news items have been observed: Lilly initiated a Ph1 tirzepatide trial evaluating a new injection device (view CT.gov record); Novo Nordisk and Aspect Biosystems announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics for diabetes and obesity (view press release); Sanofi announced it has withdrawn and refiled its Premerger Notification and Report Form under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its pending acquisition of Provention Bio (view press release); and Glooko announced a new global partnership with Hedia (view press release). Below, FENIX provides highlights and insights into the respective news items including thoughts on Lilly’s potential new injection device. 

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.

FENIX Analysis: Lilly Oral GLP-1RA Pivotal Program

Lilly initiated the first Ph3 trial in its QD oral GLP-1RA (orforglipron; LY3502970) T2DM pivotal program, called “ACHIEVE.” The ACHIEVE-4 trial is comparing orforglipron vs. insulin glargine in patients with T2DM and obesity or overweight at increased CV risk (view CT.gov record). Below, FENIX provides insights into the orforglipron development program, including thoughts on why Lilly will forego a post-marketing T2DM CVOT in favor of an obesity CVOT.

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 Recalls FreeStyle Readers

On April 4, 2023, FDA posted an announcement to its Medical Device Recalls page identifying Abbott’s recall on the FreeStyle Libre family of readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash CGMs for risk of extreme heat and fire as a Class I Recall (view FDA announcement). Below, FENIX provides brief insight into the impact of the recall.

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.