Tag Archives: astrazeneca

AZ/Fibrogen Receive Roxadustat CRL

AstraZeneca and Fibrogen announced FDA issued a CRL regarding the roxadustat NDA for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. Recall, in July 2021, FDA held an advisory committee that voted 1-13 and 2-14 against the approval of roxadustat for the NDD and DD populations, respectively (previous FENIX insight). According to the press release, FDA is requesting additional clinical study be performed prior to resubmitting the roxadustat application. AZ and Fibrogen are working with FDA to evaluate next steps.

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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Viatris and Senseonics Q2 ’21 Earnings Updates; Forxiga CKD EU Approval; GoodRx and BI Patient Access Initiative; Diamyd EU Patent Granted; New Glooko CTO

A series of cardiometabolic-related news items have been observed: Viatris and Senseonics hosted their respective Q2 ’21 earnings calls; AstraZeneca announced EU approval of Forxiga for the treatment of CKD in adults with and without T2DM; GoodRx and BI announced an initiative to increase access to cost-savings programs for patients with T2DM and COPD; Diamyd announced the European Patent Office has granted the Diamyd’s recent patent application for treatment using GAD; and Glooko announced Prakash Menon has been appointed as the company’s Chief Technology Officer. 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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AZ and Regeneron Collaborate on Obesity Treatment Development

AstraZeneca and Regeneron announced a collaboration for the research, development, and commercialization of small molecule compounds against the GPR75 gene to treat obesity and related comorbidities. For context, genetic mutations in GPR75 have been linked to patients having a lower BMI and experiencing a 54% lower risk of obesity than those without the mutation. According to the press release, AZ and Regeneron will evenly split the research and development costs as well as any future profits.

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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Bydureon BCise US Pediatric Approval; Biocon FY Q1 ’22 (CY Q2 ’21) Earnings Update; Afrezza Pediatric Ph3 Trial Observed

A series of diabetes-related news items have recently been observed: AZ announced FDA approval of Bydureon BCise for patients 10-17 years of age with T2DM; Biocon hosted its FY Q1 ’22 (CY Q2 ’21) earnings call; and a CT.gov record has been observed for MannKind’s first Afrezza Ph3 pediatric study, called INHALE-1. 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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Roxa Adcom Votes Overwhelmingly Against Approval in NDD (1-13) and DD (2-12)

Today, FDA held an advisory committee meeting to discuss the proposed roxadustat indication for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults. The panel voted 1-13 and 2-12 against either NDD or DD approval, respectively. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for AZ/Fibrogen and Akebia/Otsuka’s vadadustat.

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 Adcom Docs Released: FDA Mixed on Risk-Benefit

Today, FDA released the briefing documents for the July 15 roxadustat advisory committee. Overall, the documents have a mixed tone, making the outcome unclear for the two voting questions posed to the 15 voting panelists. Below, FENIX provides highlights and insights from the documents, including a prediction that the adcom vote will be split while still favoring Fibrogen/AZ due to the composition of the adcom panel.

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.

Roxadustat Adcom May Be Impacted By Roster Changes

Ahead of the AstraZeneca/Fibrogen roxadustat FDA adcom on July 15, 2021, FENIX has identified a recent event that may be impactful to the overall result. More specifically, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) roster has been updated with three committee member terms ending and two new members being added. Below, FENIX provides thoughts on how the updated roster could favor/disfavor AZ/Fibrogen.

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.

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.

Glooko Raises $30M Series D; AZ and BrightInsight Launch Digital Platform; Oramed Randomizes 25% of Patients in Ph3 Oral Insulin Trial

Three diabetes-related news items have been observed: Glooko announced it raised $30M in a Series D funding round; BrightInsight announced the launch of AstraZeneca’s AMAZE Disease Management Platform for chronic diseases, including diabetes, heart failure, and CKD; and Oramed announced it has enrolled and randomized 25% of the 675 patients planned for its Ph3 oral insulin trial in T2DM. Below, FENIX provides highlights and insights for the respective news items, including thoughts on Glooko’s Series D being a down round.

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.

Farxiga DAPA-CKD Receives Priority Review from FDA

AstraZeneca announced FDA granted Priority Review to Farxiga for the treatment of chronic kidney disease in patients with and without T2DM based on results from the DAPA-CKD study. Recall, FDA previously granted Breakthrough Therapy designation to Farxiga for CKD in October 2020 following positive results from the DAPA-CKD trial which were first presented at ESC 2020. Of note, AZ stated the PDUFA date will occur in Q2 ’21. Below, FENIX provides a projected approval timeline for the impending DAPA-CKD regulatory review as well as readthrough to the SGLT2i class.

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.