Tag Archives: Medtronic

Medtronic Resolves FDA Warning Letter; HSR Waiting Period for Sanofi’s Provention Bio Acquisition Expires; Roche Q1 ’23 Earnings

Three cardiometabolic-related news items have been observed: Medtronic announced FDA lifted the warning letter issued at its diabetes headquarters in Northridge, CA, in December 2021 (view press release); Sanofi announced the waiting period under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its proposed acquisition of Provention Bio has expired (view press release); and Roche hosted its Q1 ‘23 earnings call (press release; slides). 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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Lilly to Divest Baqsimi to Amphastar; Medtronic 780G+GS4 FDA Approval; April CHMP Agenda

Three cardiometabolic-related news items have been observed: Lilly announced it entered into a definitive agreement with Amphastar Pharmaceuticals to divest Baqsimi worldwide rights (view press release); Medtronic’s MiniMed 780G system with the Guardian Sensor 4 (GS4) has received FDA approval (view press release); and the CHMP agenda (view here) for this month’s meeting (April 24-26) has been released. Below, FENIX provides highlights and insights into the respective news items including insight into Lilly’s potential strategy behind the Baqsimi move.

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’s Project Liberty Motives Are Confusing

At ATTD 2023, Dexcom hosted a symposium where it highlighted “Project Liberty,” a follow-on R&D initiative stemming from Dexcom’s 2018 acquisition of TypeZero. Dexcom said Project Liberty is intended to move AID algorithms beyond T1DM and into a broader subset of patients with diabetes, including T2DM. However, it is not readily apparent as to Project Liberty’s business case. Below, FENIX provides thoughts and hypotheses as to what Dexcom’s strategic rationale could be regarding Project Liberty.

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 and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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.

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

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

Viatris’s Generic Dapagliflozin and Lilly’s Trulicity Pediatric Extension Receive Positive CHMP opinions; Medtronic’s Wearable Partner Files for Bankruptcy; Nemaura Looks to Raise Additional Capital

Four cardiometablic-related news items have been observed: Viatris’s generic dapagliflozin received a positive CHMP opinion for the treatment of T2DM, HF, and CKD (view opinion); Lilly’s Trulicity received a positive CHMP opinion for a label extension to include patients ages 10 years and older (view opinion); Medtronic’s wearable partner, Rockley Photonics Holdings Limited, has filed for bankruptcy (view Form 8-K); Nemaura announced it has entered into a definitive agreement of ~$8.4M registered direct offering and concurrent private placement with two healthcare-focused US institutional investors (view press release). Below, FENIX provides highlights and insights including thoughts on an acquisition opportunity for Medtronic.

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.

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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Holiday Hangover: Novo’s Wegovy/Ozempic Featured on 60 Minutes; Intercept OCA NASH NDA Refiled; Amgen Initiates Ph2 AMG 133 Obesity Trial; Steven Russell Joins Beta Bionics; Novo’s Third Cagrisema Ph3 Trial Initiated; Wegovy Pediatric Indication; Lannett Bs-Insulin Updates; Equillium and Metacrine Terminate Merger; and More

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Intercept, Amgen, Beta Bionics, Lannett, Equillium and Metacrine, MindRank, EOFlow, Medtronic, Adocia, and PeptiDream. 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.

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 InPen App Recall; Libre 3 + Ypsomed AID Available in Germany; Altimmune Positive Pemvidutide NAFLD Data; Embecta CY Q3 ’22 Earnings Update; Alnylam Submits ALN-KHK CTA for T2DM; Biocorp Receives EU Medical Device Certification

A series of cardiometabolic-related news items have been observed from Medtronic, Abbott, Altimmune, Embecta, Alnylam, and Biocorp. Below, FENIX provides highlights and insight on the respective news items, including thoughts on the Medtronic recall and how the positive Altimmune NAFLD data may not be enough.

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 Q3 ’22 Earnings Update; Novo Expands Manufacturing Facilities; FDA Approves Lilly’s Rezvoglar as an Interchangeable Biosimilar; Oramed Presents Additional Ph2 PRMD-0801 NASH Data

Four cardio-metabolic related news items have been observed: Medtronic hosted its CY Q3 ’22 earnings call (press release; slides); Novo announced plans to invest DKK 5.4B (~$750M USD) in the expansion of manufacturing facilities in Denmark (view press release); FDA approved Lilly’s Rezvoglar (bs-glargine) as an interchangeable to Sanofi’s Lantus (view label; view article); and Oramed hosted an event to discuss data from its Ph2 trial evaluating 8mg ORMD-0801 compared to placebo in 32 participants with T2DM and NASH (slides; webcast; press release). 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.