Category Archives: DPP-IVi

Icodec up for CHMP Opinion; March CHMP Agenda; Galmed Granted MASH Combo Patent; Sequel’s twiist AID Receives 510(k) Clearance

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (March 18-21) has been released and Novo Nordisk’s insulin icodec is up for an opinion (view CHMP agenda); Galmed announced it was granted an EU patent for the combination of aramchol and resmetirom for the treatment of MASH and liver fibrosis (view press release); and Sequel Med Tech announced it received 510(k) clearance for the twiist AID system (view press release). Additionally, FENIX has provided a correction to Novo’s new Rybelsus doses based on information from its Q3 2023 earnings 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.

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SELECT up for CHMP Opinion?; January CHMP Agenda; Akero Initiates Ph3 EFX MASH Trial

Two cardiometabolic-related news items have been observed: the CHMP agenda (view here) for this month’s meeting (January 22-25) has been released and includes Novo’s SELECT; and Akero initiated the second Ph3 study evaluating EFX in participants with non-cirrhotic MASH and F2 or F3 fibrosis (SYNCHRONY Histology; view CT.gov record). 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.

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Purchase Blast$599.00

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Novo to Displace Metformin as 1L T2DM Treatment?; Zealand Presents Amylin Analog Data at ObesityWeek; JNJ Q3 ‘23 Earnings

Three cardiometabolic-related news items have been observed: Novo Nordisk initiated a Ph3 study evaluating high-dose oral sema vs. Jardiance and vs. metformin in T2DM (view CT.gov record); Zealand announced presentations of clinical and non-clinical results from its amylin analog (ZP8396) at ObesityWeek 2023 (previous FENIX insight); and Johnson & Johnson hosted its Q3 ‘23 earnings call (view press release; slides). Below, FENIX provides highlights and insights into the respective new items, including thoughts on how Novo may be trying to displace metformin as first-line treatment for T2DM. 

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.

Ozempic Label Update; AZ, BMS, Merck, and BI to Participate in Medicare Price Negotiations; FDA and Health Canada Clear Expansion Portion of Biomea’s Ph2 Oral Menin Inhibitor Trial in T2DM

Three cardio-metabolic related news items have been observed: FDA updated the Ozempic label to include ileus (intestinal blockage) as an adverse reaction reported post-approval (view updated label); AZ, BMS, Merck, and BI have reportedly agreed to participate in the first round of Medicare price negotiations (view article); and Biomea Fusion announced FDA and Health Canada cleared the expansion portion of its Ph2 COVALENT-111 study evaluating BMF-219, an oral covalent menin inhibitor, in T2DM (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.

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Purchase Blast$599.00

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Lilly Initiates Additional Ph3 Orforglipron Trial; Mounjaro Label Update; Vertex, Amarin, and Intercept Q2 ‘23 Earnings; Glenmark Receives ANDA Approval for 2.5mg and 5mg Saxagliptin; Dario Introduces GLP-1RA Obesity Program; Tandem Initiates Sigi Patch Pump Trial

A series of cardiometabolic-related news items have been observed from Lilly, Vertex, Amarin, Intercept, Glenmark, Dario, and Tandem. 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.

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Purchase Blast$599.00

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Novo Files Lawsuit Over Third-Party Semaglutide Promotion; Versanis Bio Completes Enrollment of Ph2b Bimagrumab Study in Obesity; FDA Approves Jardiance and Synjardy for Pediatric T2DM and Lodoco for ASCVD

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it is taking legal actions over third-party semaglutide promotion (view press release); Versanis Bio announced it completed enrollment for the global Ph2b BELIEVE study evaluating the safety and efficacy of bimagrumab as a monotherapy and in combination with semaglutide in participants with obesity (view CT.gov record); FDA approved Jardiance and Synjardy to improve glycemic control in children 10 years of age and older with T2DM (view press release) as well as Agepha Pharma’s Lodoco in adult patients with established ASCVD or with multiple risk factors for cardiovascular disease (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the bimagrumab + semaglutide program. 

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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Diabeloop Initiates DBL-4pen Trial; Glenmark’s Generic Onglyza Receives Tentative Approval

Two cardiometabolic-related news items have been observed: Diabeloop initiated a trial evaluating its self-learning AID software via the DBL-4pen smartphone app in patients with T2DM in France (SERENIT2; view CT.gov record); and FDA granted tentative approval for Glenmark Pharma’s generic saxagliptin (Onglyza) 2.5mg and 5mg tablets (view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including readthrough from the Diabeloop trial for Sanofi and Novo.

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.

Diamyd Initiates Ph2 Trial in At-risk Individuals; Teladoc Cuts 300 Jobs; Merck to Resolve Sitagliptin Contamination Issue

Three cardiometabolic-related news items have been observed: Diamyd initiated a new Ph2 trial evaluating its vaccine in individuals at risk for T1DM (DiaPrecise; view CT.gov record); Teladoc disclosed it is laying off 300 employees which represent 6% of its workforce (view Form 8-K); and Merck has determined the source of the sitagliptin NTTP contamination issue (view article). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Diamyd’s development plan in the context of the ongoing Tzield launch.

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.

EASD 2022 Key Press Releases (Sept 22)

On the fourth day of EASD 2022, three key news items were observed from Novo Nordisk, Merck, and Better Therapeutics. Separately, it has been observed that the start date has been delayed for Novo’s first cagrisema Ph3 pivotal trial (Ph3 REDEFINE-2). Below FENIX provides insights and context for the respective announcements.

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.

FDA Detects Impurities in Samples of Merck’s Januvia; Senseonics and Ionis Q2 ’22 Earnings Updates

Three cardiometabolic-related news items have been observed: FDA’s website has been updated noting elevated levels of NTTP have been observed in samples of sitagliptin (view here); and Senseonics (press release) and Ionis (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.