Tag Archives: diamyd

CHMP Denies Mounjaro OSA Indication; FLOW Positive CHMP Opinion; New Oramed Oral Insulin Study; Diamyd and FDA Align on Accelerated Approval; Noom to Offer Metformin for Weight Loss

A series of cardiometabolic-related news items have been observed from CHMP, Oramed, Diamyd Medical, and Noom. 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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Diamyd Ph3 Recruitment Update

Diamyd Medical announced it has enrolled 180 patients in the Ph3 DIAGNODE-3 trial (view CT.gov record), exceeding the recruitment target set for the planned early readout in March 2026. For context, DIAGNODE-3 is evaluating the Diamyd diabetes vaccine in 330 recently diagnosed T1DM patients 12-28 years of age who carry the HLA DR3-DQ2 haplotype (previous FENIX insight). Recall, in September 2024, Diamyd announced it will pursue accelerated approval in the US (previous FENIX insight). Below, FENIX provides brief insight on the Diamyd approval timeline.

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 2024 Key Press Releases (Sep 09)

On the first day of EASD 2024, six key news items were observed from Terns Pharmaceuticals, Zealand Pharma, Diamyd Medical, Cytokinetics, Lilly/Superluminal Medical, and Akero Therapeutics. The following topics are covered below (hyperlinks to external 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 Loses Counterfeit Tirzepatide Lawsuit; EMA Finds No Link Between GLP-1RAs and Suicide Ideation; Diamyd Ph3 Recruitment Update

Three cardiometabolic-related news items have been observed: Lilly loses counterfeit tirzepatide lawsuit (view article); EMA found no link between GLP-1RAs and suicide ideation (view meeting highlights); and Diamyd reached a recruitment milestone for its Ph3 DIAGNODE-3 trial in T1DM (view press release). 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 Launches Mounjaro in the UK; Mannkind Completes INHALE-1 Enrollment; Diamyd Receives Fast Track Designation in T1DM; Alnylam Q4 ’23 Earnings

A series of cardiometabolic-related news items have been observed from Lilly, Mannkind, Diamyd, and Alnylam. 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.

Altimmune’s Pemvidutide Receives Fast Track Designation in NASH; New Diamyd T1DM Results; Viking and Merck Q3 ’23 Earnings

Four cardiometabolic-related news items have been observed: FDA granted Fast Track Designation to Altimmune’s pemvidutide for the treatment of NASH (view press release); Diamyd announced results from a retrospective follow-up study of two prior trials, DiAPREV-IT and DiAPREV-IT2 (view press release); Viking (press release) and Merck (press release; slides) hosted their respective Q3 ’23 earnings call. 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 Hires CordenPharma to Make Mounjaro; Diamyd Booster Results

Two cardiometabolic-related news items have been observed: Lilly has reportedly hired CordenPharma to produce Mounjaro (view article); and Diamyd Medical announced preliminary results from DIAGNODE-B which provided additional support for the safety and feasibility of booster injections of Diamyd (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.

Abbott to Acquire Bigfoot; Novo Launches Wegovy in UK; Sernova and Glyscend Appoint New CEOs; SomaLogic Expands Agreement with Novo Through 2025; Novo’s Biocorp Acquisition Updates; Diamyd to Initiate Ph3 DIAGNODE-3 in US

A series of cardiometabolic-related news items have been observed from Abbott, Novo, Sernova, Glyscend, SomaLogic, Biocorp, and Diamyd. Below, FENIX provides highlights and insights for the respective news items. Of note, FENIX will be conducting an in-depth analysis on the Abbott/Bigfoot acquisition in the coming days.

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 and Zealand Announce Positive Ph2 BI 456906 Obesity Results; Senseonics and MannKind Q1 ’23 Earnings; Sanofi Study Demonstrates Benefit of Dario; MyFitnessPal and Google Health CGM Integration; Diamyd’s Remygen Fails To Support Durable Treatment Effect

A series of cardiometabolic-related news items have been observed from BI and Zealand, Dario and Sanofi, MyFitnessPal and Google Health, and Diamyd Medical. Additionally, Senseonics and MannKind hosted their respective Q1 ’23 earnings calls. 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.

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.