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.
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.
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.
Tandem hosted their Q2 ’17 earnings call and issued a press release, providing financial updates as well as updates regarding t:slim LCM.
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).
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.
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.
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.
An ADA abstract titled “A Novel Formulation of Insulin Lispro Containing Citrate and Treprostinil Shows Faster Absorption and Improved Postprandial Glucose Excursions vs. Humalog in Patients with T1DM” will be presented by Lilly at the General Poster Session on June 10, 2017.
J&J hosted their pharmaceutical business review and provided commentary on the Invokana boxed warning, CANVAS/R and CREDENCE, and their pipeline dual GLP-1/glucagon agonist from Hanmi.