Category Archives: Topics

High-dose Trulicity Approved by FDA

Lilly announced FDA approval of high-dose Trulicity (3.0 and 4.5mg; view updated label here) which is in-line with FENIX’s projection of August-September 2020 (previous FENIX insight). Per the updated Trulicity label, patients requiring additional glycemic control can uptitrate to the 3.0mg Trulicity dose after 4 weeks on the 1.5mg dose. An additional 4 weeks on the 3.0mg dose is required before moving to the 4.5mg dose. Below, FENIX provides an overview of the high-dose Trulicity label update and additional thoughts its approval.

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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Medtronic to Restructure Business; Nemaura proBEAT and sugarBEAT Launch Updates

Two diabetes-related news items have been observed: yesterday, Medtronic filed a form 8-K, reporting that the company is reorganizing its current business with the intention of saving ~$450M annually (view Form 8-K) and Nemaura Medical presented at the LD 500 virtual investor conference and discussed updates to its sugarBEAT and proBEAT US and ex-US commercial plans (press release; view presentation). Below, FENIX provides insight into how the Medtronic reorganization may impact its diabetes business as well as an updated perspective on the potential impact of Nemaura’s non-invasive CGM.

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bluebird bio Highlights Ide-cel Resubmission; Q2 2020 Earnings Call

On Wednesday, August 5, bluebird bio released their Q2 2020 financial results (press release). No new data was reported; however, the company highlighted the successful resubmission of their ide-cel BLA application. Below, Celltelligence provides insights on ide-cel’s potential approval date in the EU and a possible alternative messaging strategy for the CAR-T in earlier lines of therapy.

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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Former Head of BI Diabetes/CardioMetabolism Joins Novo

Boehringer Ingelheim’s former Head of Medicine for the Diabetes and CardioMetabolism business, Jyothis George (pictured below; view LinkedIn profile), has recently joined Novo Nordisk as the VP of Clinical, Medical, and Regulatory for Northwest Europe. Below, FENIX provides thoughts on George’s move, including insight into why it seems to make sense given Novo’s expanding focus beyond diabetes.

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.

ACC 2021 Scheduled as Live Conference

ACC announced that its 2021 conference is scheduled to be held live in Atlanta, GA from May 15-17 (view conference website). While there is no additional information on the ACC 2021 website, it seems likely that there would be a large virtual component to the meeting, catering to those who are unable or unwilling to travel. Furthermore, the conference organizers are presumably making backup plans to host an entirely virtual conference in the event the COVID-19 pandemic prohibits a live 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.

Libre 2 Available for Medicare Patients; Senseonics Receives Positive Medicare Local Coverage Determinations

Abbott announced its Libre 2 CGM system is now available for Medicare patients. Additionally, Senseonics announced that three Medicare Administrative Contractors (MACs) issued Local Coverage Determinations for the use of implantable CGMs. Below, FENIX provides insight into the Abbott and Senseonics Medicare news, including thoughts on how Abbott is more likely to benefit than Senseonics/Ascensia due to the ongoing COVID-19 pandemic.

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.

AZ Provides Additional DAPA-CKD Commentary During Post-Results Investor Call

Following the DAPA-CKD results, which were presented at ESC 2020 on August 30 (previous FENIX insight), AZ hosted a call with investors (view slides here). Beyond reviewing the DAPA-CKD results, AZ senior management and DAPA-CKD investigators provided commentary on the trial results and the new Farxiga market potential. Below, FENIX provides highlights from the investor call as well as additional perspective on the impact of DAPA-CKD.

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 Allogene’s AlloCAR Program; Q2 2020 Earnings Call Summary

On Wednesday, August 5, Allogene held their Q2 2020 conference call (press release / company presentation). The company highlighted presented ASCO data from the ALLO-501 (CD19 allogeneic CAR-T) Ph1 ALPHA study in ≥3L NHL (DLBCL or FL) (Sattva Neelapu et al, May 2020). Management confirmed that the pivotal Ph1/2 ALPHA-2 study of ALLO-501A is underway, with no reported DLTs in the dose level 1 (DL1) cohort. Below, Celltelligence provides key takeaways about Allogene’s CAR-T clinical program, and thoughts on potential hurdles the company may face re-treating patients that have already received Gilead and Novartis’s CAR-Ts in earlier lines of therapy.

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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BMS Highlights Ide-cel FDA Re-submission; Q2 2020 Earnings Call

On Thursday, August 6, BMS held their Q2 2020 results (press release / presentation). The company briefly discussed their CAR-T program, highlighting that the BLA for ide-cel in ≥4L RRMM has been re-submitted. In addition, management stated that they look forward to the November PDUFA date for liso-cel in ≥3L DLBCL. Below, Celltelligence provides thoughts on BMS’s two leading CAR-Ts, both of which have experienced delays to their FDA reviews.

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.

Medtronic’s 770G Pump Approved in Peds Down to 2 Years of Age

FDA has approved Medtronic’s MiniMed 770G hybrid closed-loop system in patients down to 2 years of age (view FDA press release). At the time of this publication, Medtronic had not yet issued its own press release. Recall, the 770G pump uses the same hybrid closed-loop algorithm that is available with the current 670G system, but 770G is BLE-enabled. Below, FENIX provides brief thoughts on the 770G approval.

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.