Tag Archives: Diabetes

Lilly’s Ph3 Tirzepatide SURPASS-4 Results Published in Lancet; FDA Pre-Submission for rt-Glucose Salivary Test; Ultrahuman Hires Chief Business Officer; J&J Q3 ‘21 Earnings Update

A series of cardiometabolic-related news items have been observed: Lilly announced results of its Ph3 SURPASS-4 trial comparing tirzepatide to insulin glargine in patients with T2DM and an increased CV risk were published in The Lancet (view publication); IQ Group Global announced that GBS Inc has filed a pre-submission package with FDA for its salivary glucose test; Ultrahuman announced Bhuvan Srinivasan will join the company as its first chief business officer; and J&J hosted its Q3 ’21 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items.

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Medtronic to Acquire Triple Jump?; Esperion to Reduce Workforce by 40%; Diamyd’s Ph3 T1DM Vaccine Trial Initiated; Vertex Announces Positive Results From Ph1/2 VX-880 Trial

A series of cardiometabolic-related news items have been observed: It has been reported that Medtronic is in advanced discussions to acquire a patch pump company (view article); Esperion announced plans to align operational and expense structure, including a workforce reduction of 40%; Diamyd announced the initiation of its Ph3 T1DM Vaccine trial (DIAGNODE-3) in Europe; and Vertex announced positive results from the first patient in Ph1/2 VX-880 trial for patients with T1DM. Below, FENIX provides highlights and insights for the respective news items.

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G&L Bs-glargine Completes Ph3; Adocia’s BC Lispro Cleared for Pivotal Ph3 in China; Dario Signs National Digital Behavioral Health Contract

A series of cardiometabolic-related news items have been observed: Gan & Lee announced the conclusion of its two Ph3 bs-glargine studies; Adocia announced that its partner, Tonghua Dongbao, received clearance to initiate a Ph3 trial for uRAI BioChaperone Lispro in China; and Dario announced it was selected as the digital behavioral health provider for an undisclosed US national health plan. Below, FENIX provides highlights and insights for the respective news items.

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Dexcom Launches Garmin Connect IQ Apps for Dexcom G6; Dexcom Expands TIR Educational Campaign in UK

Two diabetes-related news items have been observed, both from Dexcom: Dexcom announced that US patients with diabetes can now view Dexcom G6 CGM data on their Garmin smartwatch and cycling computer; Dexcom announced the expansion of its TIR Initiative in the UK. Below, FENIX provides further highlights and insights for the respective news items.

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vTv Therapeutics Announces Positive Results from TTP399 Mechanistic Trial; Non-Invasive CGM From Innovation Zed Advances

Two diabetes-related news items have been observed: vTv Therapeutics announced positive results of TTP399 mechanistic study in patients with T1DM; Innovation Zed announced research advancements for its non-invasive CGM project. Below, FENIX provides further highlights and insights for the respective news items.

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New NovoPen 6 Connected Pen Trial in T1DM (CONNECT 1); Lilly-sponsored Treprostinil/Sodium Citrate Infusion Site Pain Trial in T1DM; Dario Partners with New Employer Group; Ascensia Launches “This is Diabetes” Competition

A series of diabetes-related news items have been observed: Novo has initiated a NovoPen 6 connected pen observational trial in T1DM (CONNECT 1; view CT.gov record); Lilly has initiated a treprostinil/sodium citrate infusion site pain trial in T1DM (view CT.gov record); Dario announced a new agreement with a US global employer; Ascensia announced launch of “This is Diabetes” competition. Below, FENIX provides further highlights and insights for the respective news items. 

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Medtronic Expands 630G/670G Pump Recall; Xeris Completes Acquisition of Strongbridge; DreaMed FDA Clearance for AI-based Clinical Decision Support System for T2DM; Know Labs Bio-RFID Readings Comparable to FDA-Cleared Devices

A series of cardiometabolic-related news items have been observed: Medtronic recalled 600 series insulin pumps (view FDA website); Xeris announced the closing of its acquisition of Strongbridge BioPharma; DreaMed announced FDA clearance of its AI-based clinical decision support system, called Advisor Pro, for patients with T2DM; Know Labs published a report that shows the accuracy of its non-invasive Bio-RFID technology blood glucose sensor is comparable to FDA-cleared devices (press release; view report). Below, FENIX provides further highlights and insights for the respective news items.  Medtronic expands 630G/670G pump recall Medtronic recently recalled an expanded set of its 600 series insulin pumps (630G and 670G)……

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BI/Lilly Launch Educational CVRM Game for HCPs; MannKind INHALE-1 Pediatric Study Enrolls First Patient; Dietitian-based Resource with PWD Launched

Three cardiometabolic-related news items have been observed: BI/Lilly announced the launch of an educational initiative for HCPs, called CRMSynced, which uses gamification to encourage HCPs to prioritize a holistic approach to disease management; MannKind announced the first patient has been enrolled in the Afrezza Ph3 pediatric study; Teatis announced the launch of Teatis RD on Demand, a resource designed to connect people with diabetes to dietitians who can assist in managing their disease through personalized meal plans. Below, FENIX provides highlights and insights for the respective new items.

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Kerendia Early Launch and HCP Website Analysis

Bayer has updated its Kerendia HCP website with new messaging for finerenone following FDA approval in July 2021. Recall, the Kerendia HCP website previously was active with simple “now approved” messaging and was bare aside from a link to the press release, webinar sign up, speak with a Kerendia representative, and the prescribing information. Of note, the patient website appears to be largely unchanged since the initial approval. Below, FENIX provides an analysis of the initial Kerendia HCP messaging and early Kerendia Rx data, including a time-aligned launch comparison with other key brands.

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