Tags : Insulin

Lilly Signs Agreement with Ypsomed to Advance an Automated Insulin

Shots: In terms of the agreement, lilly will commercialize the system, which is currently in development & will include an insulin pump developed & manufactured by ypsomed Ypsomed’s insulin pump has been marketed in europe since 2016, available in 21 countries as the mylife ypsopump. Lilly will commercialize a version of this insulin pump, along […]Read More

The US FDA to Waive Interchangeability Standard for Insulin Biosimilars

Shots: Two doctors called for interchangeability requirements for biologics to be waived for insulin products under the Biologics Price Competition and Innovation Act (BPCIA) of 2009 The FDA guidance is a reminder that the rules of BPCIA should be carefully reinterpreted in order to maximize benefit, affordability, and access to insulin for all patients with […]Read More

Tandem’s Predictive Insulin Pump Software Receives the US FDA’s Approval

Shots: The US FDA has granted De Novo marketing authorization to Tandem’s Control IQ technology, a software program utilizing reading from a CGM to automatically adjust insulin delivery to a person with diabetes using Tandem’s t:slim X2 insulin pump The FDA approval is based on a clinical study evaluating Control-IQ technology controller installed on a […]Read More