Category Archives: Bolus Insulin

Insulet FY ’21 Earnings Update; Novo Partners with Vonage for IO Customer Support; Esperion, Teladoc, and Adocia Q4 ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Insulet hosted its FY ’21 earnings call (press release); Vonage recently announced Novo Nordisk has chosen Vonage Contact Center (VCC) to support Novo’s international operations customer engagement; Esperion (press release; slides) and Teladoc (press release; slides) hosted their respective Q4 ‘21 earnings calls; and Adocia published its Q4 ’21 and FY ‘21 earnings. Below, FENIX provides highlights and insights for the respective new items.

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Provention Bio Refiles Teplizumab BLA; Medtronic and Tandem Q4 ’21 and FY ’21 Earnings Updates; Lilly Invests $700M in New Lilly Institute for Genetic Medicine; RosVivo Therapeutics and Lilly Sign MTA for RSVI-301; February 21-24 CHMP Agenda

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Medtronic, Tandem, Lilly, RosVivo Therapeutics, and the CHMP. Below, FENIX provides highlights and insights for the respective new items.

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Tandem’s Mobile Bolus Feature Cleared by FDA

Tandem announced FDA has cleared its remote bolus insulin dosing feature for its t:connect mobile app. The updated t:connect mobile app provides t:slim X2 insulin pump users the ability to program/cancel bolus insulin requests through their compatible iOS or Android smartphone. Below, FENIX provides brief thoughts on what the launch of the remote bolus feature means for Tandem, Insulet, and Medtronic.

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Novo Q4 ’21 London Earnings; Sanofi and Regeneron Q4 ‘21 and FY ‘21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk hosted its post-Q4 ’21 earnings event (see previous FENIX insight on Q4 ’21 Novo earnings from February 2); and Sanofi (press release; slides; view infographic) and Regeneron (press release; slides), hosted their respective Q4 and FY ’21 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Lannett, Merck, Roche, and BD Q4 ‘21 and FY ’21 Earnings Updates

A series of cardiometabolic-related news items have been observed: Lannett (press release), Merck (press release; slides), Roche (press release; slides), and BD (press release; slides) hosted their respective Q4 ’21 earnings calls. Below, FENIX provides highlights and insights for the respective new items.

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Novo Q4 and FY ’21 Earnings Update

Novo Nordisk hosted its Q4 and FY ’21 earnings call (press release; slides) and provided updates across its commercial and pipeline activities, including the ongoing Wegovy supply shortage and a Rybelsus launch update. Of note, Novo disclosed it has been notified of four Paragraph IV ANDA filings for generic Ozempic. Additionally, Novo reminded about its upcoming 2022 Capital Markets Day on March 3, 2022. Below, FENIX provides highlights and insights from the call.

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Jardiance HFpEF Indication Extension Up for Adoption; January 24-27 CHMP Agenda

The CHMP agenda for this month’s meeting (January 24-27) has been released, and it includes one notable item, a potential CHMP opinion for Jardiance HFpEF indication extension, as well as several other agenda items. Below, FENIX provides diabetes-related highlights and insights from the January 2022 CHMP agenda.

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Arecor Initiates Ph1 Ultra-Rapid Insulin Trial in T1DM

Arecor Therapeutics announced the initiation of a Ph1 clamp study comparing its ultra-rapid insulin (AT247) to Novolog and Fiasp in T1DM patients (view CT.gov record). Recall, at EASD 2020, Arecor presented an abstract (view here) for a Ph1 study which demonstrated AT247 had a faster onset of glucose-lowering than aspart (17 vs. 50 minutes) and a greater early glucose-lowering effect compared to both aspart and faster aspart (previous FENIX insight). Below FENIX provides brief thoughts on the initiation of the Ph1 trial and Arecor’s diabetes pipeline.

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JPM 2022 Day 3: Akebia, Ionis, and Hikma; Oramed Provides Updates on Ph3 Oral Insulin Program

On the third day of JPM 2022, FENIX has provided coverage of presentations by major CVRM companies including Akebia, Ionis, and Hikma. Additionally, a separate cardiometabolic-related news item has been observed: Oramed issued an annual message to shareholders and provided an update on the ORMD-0801 Ph3 oral insulin program for T2DM (view press release). Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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