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Zealand Pharma: partner granted 'breakthrough' designation

(CercleFinance.com) - Danish biotech firm Zealand Pharma said on Tuesday that the US Food and Drug Administration (FDA) has granted breakthrough device designation for a blood-sugar control system developed by its US partner Beta Bionics.


The "iLet Bionic Pancreas System," a pocket-sized, wearable investigational medical device has been designed to control blood-sugar levels, with configurations with most insulin analogs, including Zealand Pharma's dasiglucagon.

Zealand Pharma said it now plans to advance dasiglucagon in the bihormonal artificial pancreas system into a Phase 3 development trial.

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