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Oramed Pharmaceuticals, a company focused on the development of oral drugdelivery platforms, has signed an exclusive commercial distribution agreement for the Republic of Korea with local player, Medicox Co Ltd, in relation to its oral insulin candidate.
The establishment of the DHCoE is the latest of many signs that the FDA is working closely with other stakeholders to make sure that regulations keep pace with the rapid advancements in this space. Approval of the Month: FDA Approves First Closed-Loop Monitoring and DrugDelivery Device.
The US Food and Drug Administration (FDA) has issued a Class I label for the recall of Medtronic’s MiniMed insulin pumps. The devices are used to regulate blood glucose levels by delivering precise amounts of insulin based on readings from an integrated continuous glucose monitor (CGM).
Drugdelivery specialist Aptar Group has agreed a deal to take a near two-thirds share in Voluntis, a French developer of digital therapeutics (DTx), with a view to taking full control of the company later this year. per share in the initial deal, which will give it a 64.6% stake in the company.
Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. One example is the Warning Letter FDA sent to Medtronic in late 2021 concerning a vulnerability in insulin infusion pumps. By John W.M.
The fundamental misconception among the public, the media and even some lawmakers is that higher drug list prices are the result of drug manufacturers being in a monopolistic position to endlessly raise prices on critical drugs like insulin and then rake in big profits.
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