Category Archives: Bolus Insulin

Metacrine NASH Fast Track Designation; Senseonics Receives Positive Coverage Decision for EmblemHealth; Insulet Launches Omnipod DASH in Canada

A series of cardiometabolic-related news items have been observed: Metacrine announced FDA granted Fast Track designation to MET642 for the treatment of NASH; Senseonics announced a positive coverage decision for its implantable CGM from EmblemHealth; and yesterday, Insulet announced the Canadian launch of Omnipod DASH. Below, FENIX provides highlights and insights for the respective news items.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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