Category Archives: Other

Ozempic 4-dose Pen Back in the Label; Diamyd to Initiate DIAGNODE-3 Trial “Later This Year”; Nemaura Appoints New Global Head of Digital Programs

A series of diabetes-related news items have recently been observed: Novo Nordisk’s Ozempic label has been updated once again to include an NDC for a 1mg x 4 dose 3mL pen; Diamyd announced a contract with ICON plc for the Ph3 DIAGNODE trial evaluating its Diamyd diabetes vaccine; and Nemaura Medical announced the appointment of Samantha Sanders as Global Head of Digital Programs. Below, FENIX provides highlights and insights for the respective news items, including the curious thoughts on why Novo may have had the 1mg x 4 dose pen removed from the label and added back.

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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New BI/Zealand Trials in NASH and Obesity; vTv Granted BTD for TTP399; Jaguar Gene Therapy $139M Series B; CeQur $115M Series C5; Nemaura Launches BEATdiabetes App and proBEAT CGM Pilot; BioCorp/Roche Launch Mallya in France; Amarin CEO to Retire

A series of cardiometabolic-related new items have recently been observed from Boehringer Ingelheim/Zealand, vTv Therapeutics, Jaguar Gene Therapy, CeQur, Nemaura Medical, Biocorp/Roche, and Amarin. 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

You can read the article’s full content online after purchase.

Provention Bio Delay Appears Inevitable; Better Therapeutics To Go Public; Dexcom G6 Direct Distribution in the Netherlands; Sanofi Furthers Social Responsibility Outreach; Medtronic Commits to Three Initiatives to Address Healthcare Equity; Expanded Access to CGM and Insulin Pumps in Canada

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Better Therapeutics, Dexcom, Sanofi, Medtronic, and JDRF Canada. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how bad the teplizumab delay may really be.

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.

Roxa Data Hiccup Embarrassing But Not Catastrophic

Yesterday, Fibrogen issued a press release and hosted a call with investors in which the company provided clarification on certain prior disclosures of US primary CV safety analyses from the roxadustat Ph3 program for the treatment of CKD anemia. According to the press release, while senior management was preparing for the roxadustat adcom (tentatively scheduled for July 15, 2021), it became clear that the “primary cardiovascular safety analyses included post-hoc changes to the stratification factors.” Below, FENIX provides thoughts from various angles that suggest the ~40% share price hit to Fibrogen is a non-contextualized Wall Street overreaction.

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.

AZ and Mass Gen Hospital Collaborate with AMAZE Platform; Ionis to Reduce Akcea Workforce by ~70%; Galectin Launches Website for NAVIGATE Trial in NASH; Blue Shield of California Adds Two New Services to Wellvolution Platform

A series of cardiometabolic-related news items have been observed: AstraZeneca announced a collaboration agreement with Massachusetts General Hospital to utilize the AMAZE platform in two pivotal, real-world studies for HF and asthma; Ionis disclosed a reorganization of its Akcea business, including a workforce reduction of nearly 70%; Galectin Therapeutics announced the launch of NAVIGATEnash.com to highlight the Ph2b/3 trial and educate HCPs and patients on liver cirrhosis from NASH; and Blue Shield of California announced the addition of two new services to its Wellvolution platform to provide personalized care and nutrition support for patients with T2DM. 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.

Novo Initiates Ph3 Sema NASH Trial; BrightInsight Secures $101M in Series C Funding; Amarin Receives EC Approval for Vazkepa CV Risk Reduction; Glytec Updates Glucommander Insulin Dosing Algorithm; Voluntis FY ’20 Earnings Update

A series of cardiometabolic-related news items have been observed: a CT.gov record for Novo Nordisk’s first Ph3 semaglutide NASH trial has been observed; BrightInsight announced it has raised $101M in Series C financing; Amarin announced EC approval of Vazkepa (icosapent ethyl) to reduce the risk of CV events in high-risk, statin-treated adults with elevated triglycerides (≥150 mg/dL) and either established CVD or diabetes and at least one additional CV risk factor; Glytec announced updates to its Glucommander algorithm; and Voluntis announced its FY 2020 results. 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.

Meet AZ Management Investor Event Highlights

AstraZeneca hosted its virtual Meet AZ BioPharmaceuticals Management investor event (view slides) in which it provided updates across its business, including CVRM near-term opportunities (view slides) and its emerging pipeline (view slides). Below, FENIX provides highlights and insights from the event.

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 STEP 4 Sema Obesity Results @ ENDO 2021; Oramed Second Oral Insulin Ph3 Trial Update; Dexcom Promotes Jereme Sylvain to CFO; vTv Granted New Patent for TTP399

A series of diabetes-related news items have been observed: Novo Nordisk presented results from the STEP 4 semaglutide 2.4mg obesity trial at the ENDO 2021 conference (view press release); Oramed announced it has screened the first patients in its second oral insulin Ph3 trial; Dexcom has promoted Jereme Sylvain to CFO, allowing Quentin Blackford to take over Steve Pacelli’s responsibilities for strategy and corporate development (view press release); and vTv announced the USPTO issued patent 10,952,993 protecting methods of treatment using TTP399, a novel GKA. Below, FENIX provides highlights and insights from the respective news items, including updated perspective on Oramed’s potential regulatory 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.

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.

Zealand’s Dasiglucagon Approved; March 22-25 CHMP Agenda; Fractyl Enrolls First Patient in T2DM Study; Twist Bioscience Announces Positive Preclinical Data

A series of cardiometabolic-related news items have been observed: Zealand’s dasiglucagon has been approved in the US as “Zegalogue” for the treatment of severe hypoglycemia in patients 6 years of age and older; the CHMP agenda for this month’s meeting (March 22-25, 2021) has been released; Fractyl announced the first patient has been enrolled in a pivotal trial of Revita DMR; and Twist Bioscience announced positive preclinical data in which its library identified GLP-1R antibodies that demonstrated glucose control. Below, FENIX provides highlights and insights from the respective news items, including thoughts on two potential generic sitagliptin products on the CHMP agenda.

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.

Biocorp Partners to Integrate Mallya into Diabeloop AID System; vTv Initiates New TTP399 Study; Adocia and Sigilon Q4 ’20 Earnings Updates

A series of diabetes-related news items have been observed: Biocorp and Diabeloop announced a partnership to combine Biocorp’s Mallya connected pen device with Diabeloop’s insulin delivery algorithm; vTv Therapeutics announced the initiation of a study exploring the effects of TTP399 on ketone body formation during insulin withdrawal in people with T1DM; and Adocia (press release) and Sigilon (press release) announced their respective Q4 and FY ’20 earnings. 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.