Category Archives: Topics

Autolus Provides Update on CAR-T Program; Q1 2020 Call

On Thursday, May 7, Autolus held their Q1 2020 earnings call (press release/slides), highlighting their current clinical progress, enrollment, and potential initiation of their pivotal trial AUTO1-AL1 in adult R/R ALL. Below, FENIX provides thoughts on Autolus’s cell therapy program, particularly in the context of the ongoing health emergency.

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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Thoughts on Allogene CAR-T Pipeline Update; Q1 2020 Call Summary

On Wednesday, May 6, Allogene held their Q1 2020 earnings call (webcast/press release/ slides), highlighting the off-the-shelf benefits allogeneic products have over autologous products, particularly during the COVID-19 pandemic. Below, FENIX provides thoughts on Allogene’s cell therapy program in the context of the ongoing health emergency.

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.

New MPD Insulin Savings Program Supported by Lilly, Novo, and Sanofi

Yesterday, President Trump announced a new plan to reduce the monthly cost of insulin to no more than $35 for people on Medicare Part D. The plan, which is scheduled to go into effect on January 1, 2021, is being supported by Lilly, Novo Nordisk, and Sanofi. Following the announcement, Lilly’s CEO, Dave Ricks, issued a statement lauding the new savings model, saying it “fills a critical gap that remained in the system.” Below, FENIX provides thoughts on the new plan in the context of the overall US drug pricing debate.

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 launches “Defeat Diabetes” campaign; Diamyd Announces DiAPREV-IT 2 Topline Results; Senseonics Releases Android Remote Monitoring App

A series of diabetes-related news items have been observed: Novo Nordisk launched a new social responsibility campaign called “Defeat Diabetes”; Diamyd announced DiAPREV-IT 2 topline results; and Senseonics announced the launch of the Eversense NOW remote monitoring app for Android users. Below, FENIX provides highlights and insight 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.

CREDENCE Once Again on the CHMP Agenda; CHMP Agenda May 25-28

The CHMP agenda for this month’s meeting (May 25-28) has been released, and it includes two notable items: the Invokana/Vokanamet renal protection indication (CREDENCE) and the Saxenda adolescent label extension. Of note, the May 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started on May 25. Below, FENIX provides diabetes-related highlights and insights from the May 2020 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.

New Jardiance Post-MI HF Trial (EMPACT-MI)

BI/Lilly announced plans to conduct a new pragmatic trial, called EMPACT-MI, to investigate the effect of Jardiance on heart failure patients ±T2DM who have been hospitalized with an acute MI. The trial is being conducted in collaboration with the Duke Clinical Research Institute, and is being led by Adrian Hernandez and Javed Butler. A preliminary search of CT.gov did not show any results for EMPACT-MI, and BI/Lilly did not provide a timeline of when it plans to initiate the study. Below, FENIX provides thoughts on EMPACT-MI, including BI/Lilly’s motivation to conduct such a trial as well as potential readthrough to Farxiga.

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 Dasiglucagon Filing Accepted by FDA

Zealand announced FDA has accepted the dasiglucagon HypoPal NDA with a PDUFA date set on March 27, 2021. Below, FENIX provides brief thoughts on the dasiglucagon filing acceptance.

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.

Medtronic Guardian Connect CGM Android Approval; Xeris PBH Ph2 Results; Capillary Biomedical Initiates Extended-wear Infusion Set Trial

Three diabetes-related news items have been observed today: Medtronic’s Guardian Connect is now compatible with Android, Xeris announced positive topline results from ready-to-use (RTU) glucagon in patients at risk of postprandial hypoglycemia following bariatric surgery, and Capillary Biomedical initiated a trial for its extended-wear infusion set. Below, FENIX provides highlights and insights from 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.

Medtronic CY Q1 ’20 (FY Q4 ’20) Earnings Update

Medtronic hosted its CY Q1 ’20 (FY Q4 ’20) earnings call and briefly discussed its diabetes business. Of note, Medtronic disclosed plans to launch a BLE-enabled 770G pump platform with remote updating functionality in the US ahead of the advanced hybrid closed-loop (AHCL) algorithm approval. Additionally, Medtronic will be presenting two AHCL data sets at the upcoming virtual ADA conference (June 12-16). 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.

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.

Thoughts on High-dose Trulicity Data

Late last week, Lilly announced that results from the AWARD-11 high-dose Trulicity trial had been published, with data showing up to -1.9% reduction in A1C and -10.4lb weight loss at 36 weeks with the 4.5mg dulaglutide dose (previous FENIX insight). Below, FENIX has conducted an AWARD-11 comparative analysis and provides thoughts on high-dose Trulicity in the context of Novo’s Ozempic and Lilly’s tirzepatide.

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.