Tag Archives: Diabetes

Biocorp’s SoloSmart receives CE Mark; EASD 2022 Key Press Releases (Sept 19)

On the first day of EASD 2022, Biocorp announced it received CE Mark for SoloSmart, an accessory medical device for Sanofi’s SoloStar/DoubleStar pens that records dose information (e.g., dose amount, time, and date). According to the press release, Biocorp will provide more details regarding the SoloSmart launch during its CY Q3 ’22 earnings call scheduled for September 29th. Below, FENIX provides brief thoughts on the new SoloSmart device as well as potential implications for Novo Nordisk, Lilly, and other insulin pen manufacturers.

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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Novo Partners with Microsoft for Drug Development; Novo Launches Unbranded Degludec; AZ Partners with Gatehouse Bio for HFpEF RNAi Therapeutic Development; September 2022 CHMP Agenda

Four cardiometabolic-related news items have been observed: Novo announced a partnership with Microsoft for drug development (view press release); Novo announced plans to launch an unbranded version of Tresiba (view press release); AZ partners with Gatehouse for HFpEF RNA-based drug development (view press release); the CHMP agenda for this month’s meeting (September 12-15) has been released and includes multiple cardiometabolic-related agenda items. 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.

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Purchase Blast$599.00

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FENIX Analysis: Mounjaro Launch Update

Following approval of Lilly’s Mounjaro (tirzepatide) in T2DM in May 2022 (previous FENIX insight), FENIX has conducted an initial launch analysis, including early insights from prescription trends as well as a look into the Mounjaro promotional, sampling, and copay card tactics.

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 Licenses Zealand’s Zegalogue; Adocia Announces Preclinical PoC Data for its Islet Transplant; First Patient Dosed in G&L’s QW Insulin Ph1 Trial

Three cardiometabolic-related news items have been observed: Zealand announced the licensing of Zegalogue (dasiglucagon) to Novo; Adocia announced the first preclinical PoC data for AdoShell Islets in T1DM; and Gan & Lee announced the first patient has been dosed in its QW insulin (GZR4) Ph1 trial. 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.

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Purchase Blast$599.00

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

Daprodustat FDA Adcom Scheduled for October 26, 2022

FDA has requested an advisory committee on October 26, 2022, to discuss the use of GSK’s daprodustat for the treatment of anemia due to CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adults (view FDA document here). Recall, in April 2022, FDA accepted the daprodustat NDA and set a PDUFA date for February 1, 2023, suggesting a standard review of 12 months total for an NME (previous FENIX insight). The NDA was based on positive results from five Ph3 studies in the ASCEND program which were reported in July 2021 (previous FENIX insight). Below, FENIX provides brief thoughts on the dapro adcom in the context of roxadustat and 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

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Kerendia Label Updated to Include FIGARO-DKD Data

Bayer announced Kerendia received FDA approval for an updated label to include findings from the FIGARO-DKD CVOT (view updated label). Recall, FIGARO demonstrated a 13% RRR in the primary composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hHF) in patients with CKD and T2DM (previous FENIX insight). For context, Kerendia was approved with data from the FIDELIO-DKD trial, a sister study to FIGARO. Below, FENIX provides thoughts on the new Kerendia CKD label extension, including read-through 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.

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Purchase Blast$599.00

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

Dexcom Promotes Jake Leach to COO; Biocon Receives More Form 483 Observations; Seraxis Appoints Paul Strumph as CMO; Intarcia ITCA-650 CRL Chronicle Concludes

A series of cardiometabolic-related updates have been observed: Dexcom announced Jake Leach (view LinkedIn) has been promoted to COO; Biocon announced it received more Form 483 observations; Seraxis announced the appointment of Paul Strumph (view LinkedIn) to CMO; and Intarcia Therapeutics received a letter from FDA (view here) denying a hearing for ITCA-650. 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.

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Purchase Blast$599.00

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Ypsomed Launches Remote Bolus Feature; Lannett Completes Bs-glargine Pivotal Trial; Madrigal Initiates MAESTRO-NASH Outcomes Study for Resmetirom

Three cardiometabolic-related news items have been observed: Ypsomed announced the launch of a smartphone bolus delivery feature for its mylife YpsoPump using the mylife App; Lannett announced it completed subject dosing in its Ph1 bs-glargine pivotal trial (view CT.gov record); and Madrigal announced the initiation of a Ph3 MAESTRO-NASH Outcomes study evaluating the effect of QD oral 80mg resmetirom compared to placebo in patients with compensated NASH cirrhosis (view CT.gov record). 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.

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Purchase Blast$599.00

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Thoughts on SURMOUNT-MMO after SELECT Interim Analysis

At its Q2 ’22 earnings in August, Novo Nordisk disclosed that SELECT, the Wegovy CVOT, would not stop for overwhelming efficacy at a pre-specified interim analysis (previous FENIX insight). With all the hype now passed, the trial design lens turns to Lilly’s tirzepatide obesity CVOT, SURMOUNT-MMO. Below, FENIX provides thoughts on SURMOUNT-MMO, including Lilly’s potential strategy to get a broad metabolic indication, similar to what BI/Lilly did in HF with Jardiance by eliminating LVEF label language.

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.

Under-DELIVERed: Results Parity for AZ at ESC

Results from AZ’s Ph3 DELIVER (Farxiga HF outcomes trial in HFpEF; press release) and new results from a pre-specified pooled analysis from the Ph3 DAPA-HF and DELIVER trials (press release) were presented at ESC 2022 and simultaneously published in the NEJM (view publication) and Nature Medicine (view publication), respectively. Of note, an 18% RRR was observed in the DELIVER primary composite endpoint (hHF+urgent hospitalization and CV death). Below, FENIX provides highlights, insights, and implications from DELIVER in the context of BI/Lilly’s EMPEROR-Preserved and the evolving CVRM global landscape.

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.