Category Archives: Insulin Delivery

Novo Nordisk, Tandem, Alnylam, and Regeneron Q1 ’23 Earnings

Four cardiometabolic-related news items have been observed: Novo Nordisk (view press release; slides), Tandem Diabetes Care (view press release), Alnylam Pharmaceuticals (view press release; slides), and Regeneron (view press release; slides) hosted their respective Q1 ’23 earnings calls and provided CVRM-related updates. Below, FENIX provides highlights and insights from the earnings calls.

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Medtronic Resolves FDA Warning Letter; HSR Waiting Period for Sanofi’s Provention Bio Acquisition Expires; Roche Q1 ’23 Earnings

Three cardiometabolic-related news items have been observed: Medtronic announced FDA lifted the warning letter issued at its diabetes headquarters in Northridge, CA, in December 2021 (view press release); Sanofi announced the waiting period under the Hart-Scott-Rodino Act of 1976 (HSR Act) for its proposed acquisition of Provention Bio has expired (view press release); and Roche hosted its Q1 ‘23 earnings call (press release; slides). Below, FENIX provides highlights and insights into the respective news items.

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Novartis Q1 ’23 Earnings; Insulet Basal-Only T2DM Pod Receives FDA Clearance; Vadadustat Approved by EC; Sernova Announces Positive T1DM Preclinical Data with Evotec’s iPSC-Derived ILCs

Four cardiometabolic-related news items have been observed: Novartis hosted its Q1 ’23 earnings call (press release; slides); Insulet announced its basal-only T2DM pod, Omnipod GO, received FDA clearance for use in T2DM patients 18 years of age or older (view press release); Akebia Therapeutics announced the European Commission granted marketing authorization for Vafseo (vadadustat) for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis (view press release); and Sernova announced positive T1DM preclinical data for its implantable Cell Pouch device in combination with Evotec’s iPSC-derived islet-like clusters (view press release). Below, FENIX provides highlights and insight into the respective news items.

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Lilly to Divest Baqsimi to Amphastar; Medtronic 780G+GS4 FDA Approval; April CHMP Agenda

Three cardiometabolic-related news items have been observed: Lilly announced it entered into a definitive agreement with Amphastar Pharmaceuticals to divest Baqsimi worldwide rights (view press release); Medtronic’s MiniMed 780G system with the Guardian Sensor 4 (GS4) has received FDA approval (view press release); and the CHMP agenda (view here) for this month’s meeting (April 24-26) has been released. Below, FENIX provides highlights and insights into the respective news items including insight into Lilly’s potential strategy behind the Baqsimi move.

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Lilly Invests $1.6B in Indiana Manufacturing; Dexcom and Abbott Highlight Medicare CGM Coverage Expansion; Tandem Announces Positive Control-IQ Meta-Analysis

Three cardiometabolic-related news items have been observed: Lilly announced that it will invest an additional $1.6B and add another 200 jobs to its new manufacturing sites within LEAP Innovation Park in Boone County, Indiana (view press release); Dexcom (view press release) and Abbott (view press release) separately issued statements regarding CMS’s decision to expand Medicare coverage for T2DM, including certain non-insulin-using individuals; and Tandem Diabetes announced that Diabetes Technology & Therapeutics published a meta-analysis of three Control-IQ AID trials (view press release; publication). Below, FENIX provides highlights and insights into the respective news items. 

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Medtronic and Esperion CY Q4 ’22 Earnings Updates; Akebia Receives Another FDA Response for Vadadustat; Wegovy and Vadadustat CHMP Opinions; February CHMP Agenda

A series of diabetes-related news items have been observed: Medtronic (press release; slides) and Esperion (press release; slides) hosted their respective CY Q4 ’22 earnings calls; Akebia received another FDA response regarding the vadadustat CRL appeal (press release); and the February CHMP Agenda was posted, including vadadustat and Wegovy (potential) opinions. Below, FENIX provides highlights and insights from the respective news items, including thoughts on Medtronic’s Simplera CGM approval timing.

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Diabeloop Initiates DBL-4pen Trial; Glenmark’s Generic Onglyza Receives Tentative Approval

Two cardiometabolic-related news items have been observed: Diabeloop initiated a trial evaluating its self-learning AID software via the DBL-4pen smartphone app in patients with T2DM in France (SERENIT2; view CT.gov record); and FDA granted tentative approval for Glenmark Pharma’s generic saxagliptin (Onglyza) 2.5mg and 5mg tablets (view Drugs@FDA). Below, FENIX provides highlights and insights from the respective news items, including readthrough from the Diabeloop trial for Sanofi and Novo.

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