Tag Archives: Medtronic

Holiday Hangover: Novo Completes Dicerna Acquisition; FDA Approves Novartis’s Leqvio; Lexicon Submits NDA for Sotagliflozin; CMS Medicare Coverage Expansion Includes Non-adjunctive CGMs; Viatris Beats Sanofi’s Insulin-Pen Patent Invalidation Appeal; Beta Bionics iLet Bionic Pancreas Pivotal Trials Update

During the holiday break, a series of cardiometabolic-related news items were observed from Novo Nordisk, Novartis, Lexicon, Medtronic, Viatris, and Beta Bionics. Below, FENIX provides highlights and insights for the respective news items.

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Medtronic Diabetes Receives FDA Warning; Bigfoot Hires New Senior Leaders; Omada’s mHealth Programs Gain Preferred Status on Evernorth Digital Health Formulary

Three cardiometabolic-related news items have been observed: Medtronic announced it has received a warning letter from FDA on December 9, 2021 for its Diabetes Business headquarters in Northridge, CA; Bigfoot announced the appointment of three new senior leaders; and Omada Health announced that its cardiometabolic digital chronic care programs will be included on the Evernorth Digital Health Formulary. Below, FENIX provides highlights and insights for the respective new items.

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Medtronic CY Q3 ’21 (FY Q2 ’22) Earnings Update; HAGAR’s GWave Receives Breakthrough Device Designation; Oramed Randomizes 75% of Patients in Oral Insulin Trial; Beyond Type 1 Launches Web Platform in Arabic

A series of cardiometabolic-related news items have been observed: Medtronic hosted its CY Q3 ’21 (FY Q2 ’22) earnings call (press release; slides); HAGAR announced that its non-invasive CGM (GWave) has received Breakthrough Device Designation; Oramed announced it has enrolled and randomized 75% of the 675 T2DM patients in its Ph3 trial (ORA-D-013-1) evaluating its oral insulin; and Beyond Type 1 announced it has launched its web platform in Arabic. Below, FENIX provides highlights and insights for the respective new items.

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Viatris’ Semglee Preferred on Express Scripts NPF; DreaMed’s Advisor Pro Launched in Leading Children’s Hospital; MiniMed 780G & Guardian 3 TIR In Pediatrics Comparable to Adults; Abbott and Roche Q3 ’21 Earnings Updates; vTv Therapeutics Hires New President and CEO; Adhera Adds Target Indications for MLR-1023

A series of cardiometabolic-related news items have been observed from Viatris, DreaMed, Medtronic, Abbott, Roche, vTv Therapeutics, and Adhera Therapeutics. 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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Diamyd’s Ph3 T1DM Vaccine Placed on Partial Clinical Hold; Osama Hamdy Joins Nemaura Scientific Board; Medtronic Licenses Implantable Pump; Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors

A series of cardiometabolic-related news items have been observed: Diamyd’s Ph3 has been placed on partial clinical hold (press release); Nemaura announced Osama Hamdy joined the company’s advisory board (press release); Medtronic licenses implantable insulin pump from the Alfred E. Mann Foundation (press release); Diabeloop joins the AACE Corporate Advisory Program and Appoints US Scientific Advisors (press release). Below, FENIX provides highlights and insights from the respective news items.

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Gvoke Kit Receives FDA Approval; Medtronic Q2 ’21 Earnings Update

Two diabetes news items have been observed: Xeris announced FDA approved the sNDA for Gvoke Kit (1mg/0.2 mL single-dose vial syringe kit); and Medtronic hosted its CY Q2 ’21 (FY Q1 ’22) earnings call. Below, FENIX provides highlights and insights from the Medtronic call as well as thoughts on how Xeris’s decision to develop the Gvoke Kit was likely influenced by the channel mix.

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Ascensia Launches Patient Assistance Program for Eversense; Dario Digital Health Contract; Xeris EU Distribution Agreement for Ogluo; Medtronic Extended Wear Infusion Set 510(k) Clearance; Nimium Partnership for G3PP Activator Development; TempraMed Launches Insulin Cooler Cap

Six cardiometabolic-related news items have been observed from Ascensia, Dario, Xeris, Medtronic, Nimium Therapeutics, and TempraMed. Below, FENIX provides context and analysis for the announcements.

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GSK Releases Positive Dapro Topline Results Day After Negative Roxa Adcom; Dexcom Cleared for Third-party Integration; New Medtronic Klue Trial Observed

A series of cardiometabolic-related news items have recently been observed: GSK announced positive topline results from five Ph3 studies in the ASCEND program evaluating daprodustat in patients with anemia due to CKD; Dexcom announced FDA has cleared Dexcom Partner Web APIs which now allows third-party integration with other digital health apps and devices; and a new Medtronic closed-loop trial leveraging its Klue acquisition has been observed. Below, FENIX provides highlights and insights for the respective news items.

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ADA 2021 Key Press Releases (June 28)

On day four of ADA 2021, eight cardiometabolic-related news items were observed from Bigfoot, AZ, Mannkind, Medtronic, Senseonics, BI/Lilly, Sanofi, and REMD Biotherapeutics. Below, FENIX provides context and analysis for the announcements, including thoughts on how the ALT increases observed in REMD’s Ph2 volagidemab trial could spell disaster in Ph3.

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