Category Archives: Topics

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.

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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

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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.

Lannett Announces Positive Pivotal Bs-Glargine Results; Mark Cuban’s Pharmacy Offers Janssen’s Invokana; Diamyd Partners with JDRF for Ph3 Diamyd T1DM Development

Three cardiometabolic-related news items have been observed: Lannett announced topline results from its bs-glargine U100 pivotal study (view press release; view CT.gov record); Mark Cuban Cost Plus Drug Company (view website) announced it is now offering Janssen’s Invokana, Invokamet, and Invokamet XR (view tweet); and Diamyd Medical announced it entered into a four-year research and development collaboration with JDRF to support its ongoing Ph3 DIAGNODE-3 trial in T1DM (view press release). Below, FENIX provides highlights and insights into the respective news items including potential readthrough from recent insulin price reductions announced by Lilly, Novo, and Sanofi to Lannett’s bs-glargine.

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.

NeuroBo Submits NASH IND; New Akebia Vadadustat Data; Arrowhead Earns $30M Milestone Payment from GSK

Three cardiometabolic-related news items have been observed: NeuroBo Pharmaceuticals announced it has submitted an IND to FDA for a Ph2a trial of DA-1241, a novel G-protein-coupled receptor (GPR119) agonist in development for the treatment of NASH (view press release); Akebia Therapeutics announced positive topline results from the Ph3 FO2CUS trial (view CT.gov record) evaluating vadadustat in hemodialysis patients who were converted from Mircera to three times weekly oral vadadustat for the maintenance treatment of anemia due to CKD (view press release); and Arrowhead Pharmaceuticals announced that it earned a $30M milestone payment from GSK following the start of GSK’s Ph2b trial of GSK4532990 (formerly called ARO-HSD) in patients with NASH (view press release; previous FENIX insight). Below, FENIX provides highlights and insight 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.

Wegovy and Entresto Receive Positive CHMP Opinions for Pediatric Indication Extensions

Two cardiometabolic-related news items have been observed: Novo’s Wegovy (semaglutide) received a positive CHMP opinion to extend the weight management indication to include treatment of adolescents aged 12-18 years (view March CHMP meeting highlights); and Novartis announced that CHMP has adopted a positive opinion recommending the approval of Entresto (sacubitril/valsartan) for the treatment of symptomatic HF with left ventricular systolic dysfunction in pediatric patients aged 1 to <18 years (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.