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Diabetes

Lexicon’s Zynquista: Negative Adcomm Vote In Type 1 Diabetes Includes Support For Revised Indication

Lexicon’s Zynquista: Negative Adcomm Vote In Type 1 Diabetes Includes Support For Revised Indication

Some panelists favored use in T1D patients with mild chronic kidney disease, even though that was not the original indication Lexicon proposed, which was rejected in an 11-3 vote.

Lexicon’s Sotagliflozin Returns To US FDA Panel With Narrowed Indication

Lexicon’s Sotagliflozin Returns To US FDA Panel With Narrowed Indication

The Zynquista application in type 1 diabetes received a complete response letter in 2019. This time, Lexicon seeks approval for patients with T1D and chronic kidney disease. FDA review staff said making definitive conclusions about the magnitude of glucose-lowering effects in this population is difficult, and the risk of diabetic ketoacidosis remains.

Roche Uses Its CGM To Target Unmet Needs In Diabetes Control

Roche Uses Its CGM To Target Unmet Needs In Diabetes Control

CE marking for its Accu-Chek Smartguide continuous glucose monitor means Roche is on the cusp of challenging existing major players in Europe with a device whose predictive algorithms can help sufferers plan and prepare longer into the future.

Seraxis Takes Its Islet Cell Tech Into The Clinic

Seraxis Takes Its Islet Cell Tech Into The Clinic

Emerging Company Profile: The Maryland-based biotech is working on a functional cure for type 1 diabetes that is similar to Vertex’s VX-880 – but with some key differences.