Tag Archives: Lilly

GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. Below, FENIX provides highlights and insights for the respective news items.

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Lilly and Novartis Q3 ’21 Earnings Updates

Today, Lilly (press release; slides) and Novartis (press release; slides) hosted their Q3 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items.

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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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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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Jardiance Receives Breakthrough Therapy Designation for HFpEF; Metacrine Ph2a NASH Trial Completes Enrollment; Dario Signs Northeast Regional Employer

A series of cardiometabolic-related news items have been observed: BI/Lilly announced FDA granted Breakthrough Therapy Designation (BTD) to Jardiance for the treatment of HFpEF; Metacrine announced the Ph2a trial evaluating MET642 in 180 patients with NASH has completed enrollment; and Dario Health announced it was selected as the digital health provider for a Northeast regional employer. Below, FENIX provides highlights and insights for the respective news items.

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Oral Sema Ph3 Obesity Program Initiated; GlucoModicum Appoints Former Dexcom Exec; Lilly Contributes to T1DM Camp Initiative

A series of cardiometabolic-related news items have recently been observed: a Novo Nordisk trial evaluating oral semaglutide in adults with obesity, called OASIS 1, has been observed on CT.gov; GlucoModicum announced the appointment of Peter Gerhardsson to Senior Advisor; and Lilly announced a commitment of nearly $1M donation over the next three years, in conjunction with the Helmsley Charitable Trust, to support a T1DM Camp Initiative. Below, FENIX provides highlights and insights for the respective news items.

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EMPEROR-Preserved Creates a Multitude of Complex Implications

Today, BI/Lilly presented positive full results from EMPEROR-Preserved, the heart failure outcomes trial (HFOT) for Jardiance in HFpEF. While the 21% relative risk reduction augmented the clinical utility of SGLT2i in HF, the lack of benefit in patients with a LVEF ≥60% was very surprising and opens up a multitude of implications and opportunities across CV medicine. Below, FENIX provides highlights, insights, and implications from EMPEROR-Preserved that are sure to make 2022 another dynamic year for the CV global landscape.

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