Nov. 13 Company Quick Takes: FDA panel rebuffs Jardiance; plus Nucala, Cellular Biomedicine, BeiGene, Autolus and Noile-Immune

Panel rebuffs Jardiance for Type I diabetes
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 Wednesday that available data do not support approval of Jardiance empagliflozin from Boehringer Ingelheim GmbH. The panel was asked to consider whether the benefits outweighed the risks for the SGLT2 inhibitor as an adjunct to insulin to improve glycemic control in adults with Type I diabetes; it is approved in Type II diabetes.

GSK to seek expanded label for Nucala
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said it plans to submit regulatory applications for Nucala mepolizumab next year to treat hypereosinophilic syndrome after the anti-IL-5 mAb met the primary endpoint of a Phase III study for the rare group of inflammatory disorders. GSK said it is the first treatment to show a significant reduction in flares for HES, which affects about 20,000 people globally. Nucala is approved for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis...