Category Archives: Topics

Lilly: Thoughts on Connected Diabetes Ecosystem

Lilly disclosed major announcements about its diabetes connected care strategy, including intentions to develop an in-house automated insulin-delivery (AID) device as well as a wireless smart pen injection device. As a part of this endeavor, Lilly has engaged in collaborations with Deka R&D Corp., CGM-manufacturer Dexcom, and acquired Montreal-based algorithm startup Class AP. In light of these developments, Lilly has indicated plans to initiate trials by YE 2017 and has suggested it will take 2-3 years for these new devices to reach the market.

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Tandem Q3 ’17 Earnings Update

Tandem Diabetes Care hosted its Q3 ’17 earnings call and provided updates to its pump business including the closed-loop programs. Below are highlights from the call.

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Sotagliflozin T2DM renal Ph3 studies initiated by Sanofi

Two new Sanofi-sponsored clinical trial records for sotagliflozin, SOTA-CKD3 and SOTA-CKD4 have been observed. The aim of the studies is to demonstrate that sotagliflozin provides superior A1C reductions in patients with T2DM and renal impairment (stage 3 and stage 4) compared to placebo.

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Ionis Q2 ’17 Earnings Update

Ionis hosted a Q2 ’17 earnings call and provided financial information for the quarter. During the call, Akcea financial highlights and product pipeline updates were provided. Recall, Akcea closed the company’s IPO at the end of July.

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LEADER Adcom Vote (17-2) in Favor of CV Indication

The FDA advisory committee voted overwhelmingly in favor that Novo’s Victoza CVOT, LEADER, demonstrates liraglutide 1.8mg does not have excess CV risk (19-0) and provides substantial evidence that it reduces CV risk in patients with T2DM (17-2).

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LEADER FDA Briefing Documents Released

The briefing documents for the June 20, 2017 LEADER adcom were posted by the FDA. Recall, Novo Nordisk submitted the sNDA efficacy supplement for Victoza (liraglutide 1.8 mg) on October 25, 2016, which suggests the PDUFA date will be on or around August 25 following a 10-month review.

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Invokana CANVAS/R Demonstrates 14% RRR in 3-point MACE at ADA ’17

Results of the CV outcomes trials meta-analysis for canagliflozin, CANVAS and CANVAS-R, were published in the NEJM in conjunction with the data presentation at ADA ’17. A one-hour session reviewed background and trial design including the study population and integrated analysis methods, CV outcomes, renal outcomes, safety, and context.

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Apple Mentions Dexcom at WWDC

During Apple’s keynote presentation at the Worldwide Developers Conference (WWDC), Kevin Lynch, Apple’s VP Technology, mentioned that the iWatch is able to receive real-time CGM data from Dexcom CGMs. Dexcom’s stock rose over 4% after the announcement.

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