Tag Archives: dasiglucagon

Beta Bionics’s iLet Breakthrough Designation; Roche Receives CE Mark for Novel BG Test; Glooko Receives ISO 13485 Certification

FENIX has observed several announcements across diabetes technology players. First, Beta Bionics has received breakthrough device designation for the iLet Bionic Pancreas System from the FDA. Note, Beta Bionics is the only manufacturer to receive this designation for 3 system configurations (insulin-only as well as dual-hormone and glucagon-only using Zealand’s dasiglucagon), as no other companies have disclosed configurations beyond insulin-only. Additionally, Roche announced it has received CE Mark for the Accu-Chek SugarView, a meter-free BG monitoring system. Further, Glooko has received ISO 13485 certification, meeting requirements for safety and quality of their system. Below, FENIX provides context and insights on these announcements.

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Zealand Dasiglucagon Pediatric Study Meets Primary and Secondary Endpoints

Zealand Pharma announced positive topline results from its pediatric dasiglucagon hypoglycemia rescue trial in pediatric patients from 6 to 17 years of age. Below, FENIX provides insights on dasiglucagon in the context of the recent Lilly Baqsimi (nasal glucagon) and Xeris (subcutaneous Gvoke) FDA approvals.

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Xeris Glucagon Approved by FDA; Investors Appear Unimpressed

Xeris Pharmaceuticals announced FDA approval of its Gvoke pre-filled syringe (PFS) and auto-injector for hypoglycemia rescue in patients 2 years of age and older. Xeris held an associated call with investors following the approval announcement. The approval comes exactly 3-months after the PDUFA delay imposed by FDA. Below, FENIX provides an in-depth Gvoke label analysis in the context of the recent approval of Lilly’s nasal glucagon, Baqsimi.

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