Category Archives: Basal Insulin

Updated Perspective on Nemaura’s CGM; Lifescan and Noom Collaboration; Dario Q1 ’20 Earnings Update

Several diabetes-related news items have been observed: Nemaura Medical’s CEO provided an interview regarding the company’s H2H CGM study, saying that the CGM used was Abbott’s Libre, Lifescan announced a partnership with Noom to pilot a digital diabetes and weight loss management program, and DarioHealth hosted its Q1 ’20 earnings call. Below, FENIX provides updated perspective on Nemaura’s CGM in light of the recent CEO interview, thoughts on the Lifescan/Noom collaboration, and highlights from the Dario earnings call.

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Nemaura Announces Positive Initial Data from H2H CGM Study; Mylan Q1 ’20 Earnings Update

Two diabetes-related news items have been observed: Nemaura Medical announced positive early data from a H2H trial of sugarBEAT vs. an undisclosed incumbent CGM device and Mylan hosted its Q1 ’20 earnings call. Below, FENIX provides highlights of the news items as well as thoughts on where sugarBEAT may fit within the CGM market.

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Novo Q1 ’20 Earnings Roadshow; Xeris, Teva, and BD Earnings Updates

Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective earnings calls.

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Semaglutide Positive Ph2 NASH Data; Novo Q1 ’20 Earnings Update

Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.

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Sanofi Bs-Aspart Receives Positive CHMP Opinion; No Update on CREDENCE

According to the CHMP meeting highlights, Sanofi’s bs-aspart has received a positive CHMP opinion. Of note, the Invokana/Vokanamet renal protection indication (CREDENCE) was not mentioned in the meeting highlights, suggesting additional questions were asked to the sponsor. Below, FENIX provides brief thoughts on the positive CHMP opinion for Sanofi’s bs-aspart.

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CREDENCE and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 2020 CHMP agenda.

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Efpeglenatide Officially Removed From Sanofi Pipeline; Sanofi Q1 ’20 Earnings Update

Sanofi hosted its Q1 ’20 earnings call and provided a brief update to its diabetes business, including the official removal of efpeglenatide from Sanofi’s pipeline. Unsurprisingly, the vast majority of the call was dedicated to Sanofi’s COVID-19 response and the Dupixent performance. Below, FENIX provides highlights and insights from the call.

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Adocia Pramlintide+Insulin Positive Ph1b Topline Results

Adocia announced positive results of a Ph1b study of its pramlintide+human insulin fixed-ratio combination, also called M1Pram or ADO09. Adocia is planning to host a webcast (in French) on Monday, April 27 at 12pm ET to further discuss the results. Below, FENIX provides highlights of the results and insights in the context of Xeris’s pram-insulin which is currently in Ph2 development.

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Thoughts on Lilly’s “Tempo Pen” for Connected Care

In November 2019, the product labels for Lilly’s Basaglar and Humalog were updated to include administration via a new disposable connected pen called the “Tempo Pen.” Ahead of Lilly’s Q1 ’20 earnings call on Thursday, April 23, FENIX provides thoughts on the Tempo Pen since Lilly has not made any public announcements as of yet.

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Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

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