Tag Archives: Lilly

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. 

This content is for Read Less members only.
Already a member? Log in here

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)……

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

Jardiance EMPEROR-Reduced Approved by FDA

BI/Lilly announced Jardiance received FDA approval for the treatment of HFrEF based on results from the EMPEROR-Reduced CVOT. The indication from the updated label reads “to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction.” Of note, the approval comes ~3 weeks ahead of the projected PDUFA date (September 9, 2021). In June 2021, BI/Lilly received EC marketing authorization for Jardiance as a treatment for adults with symptomatic chronic HFrEF.

This content is for Read Less members only.
Already a member? Log in here

Lyumjev Approved for Insulin Pump Use; Dario and Nemaura Q2 ’21 Earnings Updates; CHMP Agenda August 16-19

A series of cardiometabolic-related news items have been observed: Lilly announced FDA approved Lyumjev for pump compatibility; Dario hosted its Q2 ’21 earnings call (press release); Nemaura Medical published its CY Q2 ’21 (FY Q1 ’22) business update (press release); and the CHMP agenda for this month’s meeting (August 16-19) has been released. Below, FENIX highlights and insights for the respective new items.

This content is for Read Less members only.
Already a member? Log in here

Lilly Q2 ’21 Earnings Update

Lilly hosted its Q2 ’21 earnings call and provided updates across its CV/Met portfolio, specifically for tirzepatide and Jardiance. Unsurprisingly, much of the call focused on donanemab for the treatment of Alzheimer’s disease following FDA’s June 2021 approval of Aduhelm (aducanamab) for the same treatment. Of note, Lilly disclosed it intends to host an in-person investor event in December 2021 to provide pipeline updates and initial guidance. Below, FENIX provides highlights and insights from the Lilly earnings call.

This content is for Read Less members only.
Already a member? Log in here