Tag Archives: Announcements

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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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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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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Lilly’s novel uRAI lispro contains citrate and treprostinil

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.

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J&J Investor Event Summary

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.

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Invokana CKD Outcomes Trial (CREDENCE) Primary Completion Date Delayed

The ClincalTrials.gov record for the CREDENCE trial has been updated to reflect a later primary completion date. The estimated primary completion date has been pushed back from February 11, 2019 to June 28, 2019, which may be due to trial recruitment.

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Merck’s Januvia Receives CRL from FDA for TECOS

Merck has announced it received a complete response letter (CRL) regarding its submission of data from the TECOS cardiovascular outcomes trial for Januvia (sitagliptin). The company has not disclosed the reason for the CRL, but said it is working with FDA to discuss next steps.

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Lilly Increases Diabetes Manufacturing Investment in 2017

Lilly has announced intentions to invest $850M in its US operations in 2017 including $85M to expand the Trulicity device assembly operations. Additionally, Lilly announced the dedication of a $140M insulin cartridge facility.

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Lexicon Presentation at Leerink Healthcare Conference

Lexicon recently presented at the Leerink Global Healthcare Conference and provided updates to its diabetes development programs.

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