Category Archives: Bolus Insulin

Tidepool Completes FDA Submission of Tidepool Loop; Diabeloop Partners with SFC Fluidics for AID Solution

Two diabetes-related news items have been observed: Tidepool announced it completed the FDA submission of Tidepool Loop, the company’s automated insulin dosing app for managing T1DM; and SFC Fluidics announced a partnership with Diabeloop to develop a system that integrates the SFC ACE insulin pod into Diabeloop’s AID solution for patients in the US. 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.

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Holiday Hangover: FDA Approves First Generic Glucagon; Novo High-dose Sema EU Filing; Novo Extends COVID-19 Relief Program; Eversense Implantable CGM Delayed by FDA; Provention Bio’s Teplizumab Filing Accepted by FDA; Teplizumab July 2, 2021 PDUFA

During the holiday break, a series of diabetes-related news items were observed from Amphastar, Novo Nordisk, Senseonics, and Provention Bio. 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.

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Purchase Blast$599.00

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

Xeris Recieves Positive CHMP Opinion; Roche and Diabeloop Partner for AID Development

Two diabetes-related news items have been observed: Xeris announced it received a positive CHMP opinion for its ready-to-use (RTU) rescue glucagon product, called Ogluo, and Roche announced a partnership with Diabeloop to enhance Roche’s pump hardware platform. 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.

Novo Partners with Procyon Technologies for T1DM Stem-Cell Treatment; Bigfoot Expands Commercial Leadership Team; JDRF and Provention Bio Launch T1DM Screening Campaign; New Arecor Trial for Ultra-concentrated RAI; City of Hope Initiates Ph1 T1DM Vaccine Trial

A series of diabetes-related news items have been observed: earlier this week, Procyon Technologies LLC announced it has entered into a partnership with Novo Nordisk for the development of an implantable cell encapsulation device to be combined with Novo’s stem cells for the treatment of T1DM; Bigfoot Biomedical announced new hires within the company to build out its commercial team ahead of the Bigfoot Unity US launch; JDRF and Provention Bio announced the launch of T1Detect, a T1DM screening campaign; a clinical trial has been observed for AT278, Arecor’s ultra-concentrated rapid-acting insulin aspart; and City of Hope announced enrollment has opened for a Ph1 T1DM vaccine trial. 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.

Biocon/Mylan Bs-Aspart and Xeris Glucagon up for CHMP Opinions? CHMP Agenda December 7-10

The CHMP agenda for this month (December 7-10) has been released, and it includes two notable items, potential CHMP opinions for Biocon/Mylan’s insulin aspart and Xeris’s glucagon, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the December 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.

Insulet, Mannkind, and Lannett Q3 ’20 Earnings Updates

Insulet (press release), Mannkind (press release), and Lannett (press release) hosted their respective Q3 ’20 earnings calls. Of note, Insulet provided updates to its Omnipod 5 development plans, including the recent initiation of a T2DM feasibility study. Furthermore, following a meeting between Lannett and FDA in June 2020, Lannett said it is finalizing the trial protocol evaluating its bs-glargine in healthy volunteers. Below, FENIX provides highlights and insights from the calls.

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/Gilead NASH PoC Data @ AASLD; Novo Q3 ’20 London Earnings Event

Novo Nordisk hosted its post-Q3 ’20 earnings event in London (see previous FENIX insight on Q3 ’20 Novo earnings from October 30). Below, FENIX provides highlights and insights from the Novo earnings call beyond what was discussed on October 30, including insight into the impending semaglutide NASH Ph3 program initiation and thoughts on the high-dose oral semaglutide approval timeline.

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 to use PRV for Sema Obesity; Ph1 Glucose-responsive Insulin Trial Initiated; Novo Q3 ’20 Earnings Update

Novo Nordisk hosted its Q3 ’20 earnings call (press release; slides) and provided updates across its pipeline and commercial activities, including the ongoing Rybelus launch, positive ziltivekimab Ph2b topline results, and Ph1 initiation for a novel glucose-responsive insulin. Additionally, Novo disclosed plans to use its PRV for the semaglutide 2.4mg obesity FDA submission. Below, FENIX provides highlights and thoughts from the call, including insight into a hidden importance of using the PRV for the sema 2.4mg obesity filing.

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.

Negative Entresto Adcom Could Renew Interest in Sotagliflozin – Lexicon and Sanofi Q3 ’20 Earnings Updates; Lifescan Partners for Diabetes Coaching

Lexicon (press release) and Sanofi (press release; slides) hosted their respective Q3 ’20 earnings calls and provided updates to their diabetes businesses. Additionally, Lifescan announced a partnership with Cecelia Health to provide coaching and telehealth services to OneTouch users. Below, FENIX provides highlights and insights from the respective news items, including how the upcoming Entresto FDA adcom could renew M&A interest in Lexicon.

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.

Lilly, Novartis, Pfizer, and Merck Q3 ’20 Earnings Updates

Lilly, Novartis, Pfizer, and Merck each hosted their respective Q3 ’20 earnings calls and provided updates across a variety of topics. Importantly, it was disclosed that FDA has requested an advisory committee meeting to discuss Novartis’s Entresto PARAGON-HF submission. Below, FENIX provides highlights and insights from the respective earnings calls.

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.