Tag Archives: astrazeneca

AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings updates. 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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Ionis, Lexicon, and Amarin Q1 ’23 Earnings; AstraZeneca Collaborates with Sernova for Cell Therapies

Four cardiometabolic-related news items have been observed: Ionis (view press release; slides), Lexicon (view press release), and Amarin view press release; slides) hosted their respective Q1 ‘23 earnings calls and provided CVRM-related updates; and Sernova announced a preclinical research collaboration with AstraZeneca to evaluate the use of its Cell Pouch System with AstraZenaca’s therapeutic cells (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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Intercept, AZ, and Sanofi Q1 ’23 Earnings; Sanofi Completes Provention Acquisition; DRI Sells Tzield Royalties to Sanofi

Five cardiometabolic-related news items have been observed: Intercept (press release; slides), AstraZeneca (press release; slides), and Sanofi (press release; slides) hosted their respective Q1 ’23 earnings calls; Sanofi announced it has completed its acquisition of Provention Bio (view press release); and DRI Healthcare Trust announced that it has sold its Tzield royalty interests and milestone payment obligations to Sanofi for $210M (view press release). Below, FENIX provides highlights and insights from the call.

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 Q4 ’22 Earnings; Oramed to Consider M&A Opportunities

Two cardio-metabolic related news items have been observed: AstraZeneca hosted its Q4 ’22 and FY ‘22 earnings call and provided brief updates to its CVRM business, including the ongoing Farxiga LCM initiatives (press release; slides); and Oramed issued an update to shareholders (view here) in which it said the company is conducting a comprehensive analysis of the data from its discontinued Ph3 oral insulin trials. Below, FENIX provides highlights and insights into the respective news items, including thoughts on AZ’s dapa LCM initiatives ahead of its anticipated 2025 LOE.

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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Dexcom G7 Super Bowl DTC; Medtronic Initiates 780G+DS5 GCM Trial; Forxiga Receives EU Approval for Chronic HF; Merck Initiates Vericiguat Pediatric HF Trial

Four cardiometabolic-related news items have been observed: Dexcom announced plans for a second Super Bowl DTC for the G7 CGM US launch (view press release; commercial); Medtronic initiated a trial evaluating the MiniMed 780G insulin pump used in combination with the DS5 CGM (Simplera) as well as the Medtronic extended infusion set and reservoir (view CT.gov record); Forxiga (dapagliflozin) has received EU approval to expand its HF indication regardless of LVEF (view Forxiga EPAR); and Merck initiated a Ph2/3 trial evaluating the vericiguat in pediatric patients aged 28 days to 18 years (VALOR; view CT.gov record). Below, FENIX provides highlights and insights from the respective news items including commentary on how the Medtronic study could suggest the company may not believe it can achieve iCGM designation.

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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JPM 2023 Day 2: LLY, ABT, PODD, SNY, AZN, MRK, and GSK; Sernova Advances T1DM Cell Pouch Technology; Pfizer Initiates New Ph1 Oral GLP-1RA Trial

On the second day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Lilly, Abbott, Insulet, AZ, and Merck. GSK and Sanofi also presented at JPM 2023, but neither had any meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Sernova announced it has made progress toward a first in-human study for its cell pouch system (view press release); and Pfizer initiated a new Ph1 trial (view CT.gov record) for one of its oral GLP-1RA assets (PF-07081532).

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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JPM 2023 Day 1: DXCM, MDT, PFE, AMGN, VRTX, NVS, CYTK, TDOC, ARWR, and AMGN; AZ Acquires CinCor; Viking Completes Ph2b NASH Enrollment; Ionis Sells Pelacarsen Royalties

On the first day of JPM 2023, FENIX has provided coverage of presentations by major CVRM companies including Dexcom, Medtronic, Pfizer, Amgen, Vertex, Novartis, Cytokinetics, Teladoc, and Arrowhead. Alnylam, Gilead, J&J, Regeneron, and Amgen also presented at JPM 2023, but none had any meaningful discussion relating to their respective CVRM portfolios. Additionally, three separate CVRM-related news items have been observed: AZ announced the acquisition of CinCor Pharma (view press release), Viking completed enrollment of the Ph2b VOYAGE NASH trial (view press release), and Ionis entered into an agreement with Royalty Pharma to sell rights to Spinraza and pelacarsen (view press release).

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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Madrigal Wins Big with Ph3 NASH Data; Novo Expands Partnership for Dose Check; AZ Announces DELIVER Positive CHMP Opinion

Three cardiometabolic-related news items have been observed: Madrigal Pharmaceuticals announced positive topline results from its Ph3 resmetirom MAESTRO-NASH study and hosted an investor call, although the company provided conflicting guidance on the filing timeline (view press release; webcast); Amalgam Rx announced the expansion of its global agreement with Novo Nordisk for the commercialization of Dose Check (view press release); and AstraZeneca announced Forxiga (dapagliflozin) received a positive CHMP opinion for DELIVER (view press release). Below, FENIX provides insights on the respective news items, including readthrough from the Madrigal data to other NASH players.

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 Partners with Sosei Heptares for Metabolic Drug Discovery; FIGARO-DKD and DELIVER Positive CHMP Opinions

Three cardiometabolic-related news items have been observed: Sosei Heptares announced an R&D collaboration with Lilly for diabetes and metabolic diseases (view press release); Bayer announced Kerendia (finerenone) received a positive CHMP opinion for the FIGARO-DKD study (view press release); AZ’s Forxiga received a positive CHMP opinion to broaden its HF indication based on results from DELIVER (view opinion). Below, FENIX provides highlights and insights on the Lilly partnership and respective positive CHMP opinions.

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 Zealand Q3 ’22 Earnings Updates; Novo Smart Pen Integration with Libre

Three cardiometabolic-related news items have been observed: AstraZeneca (press release; slides) and Zealand (press release; slides) hosted their Q3 ‘22 earnings calls, where Zealand talked about its dual agonist’s weight loss data; and Novo Nordisk announced its smart pens can now connect to Abbott’s FreeStyle LibreLink app in the UK. Below, FENIX provides context and insight on 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.