(Reuters) – An experimental drug for ulcerative colitis and Crohn’s disease from Takeda Pharmaceutical Co could pose risk of a potentially fatal brain infection called PML even though the problem has not been seen in clinical trials, staff members of the U.S. Food and Drug Administration said on Thursday. Documents about the monoclonal antibody, called […]
Diabetes drug alogliptin fell short of U.S. Food and Drug Administration approval on Wednesday, dealing a blow to the hopes of Takeda Pharmaceutical (TYO:4502) and its partner, Furiex Pharmaceuticals (NASDAQ:FURX). The complete response letter means Takeda will need to come up with more data if it wants to try again for FDA approval on its […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Takeda Pharmaceutical’s (TYO:4502) diabetes drug alogliptin failed to secure U.S. Food and Drug Administration approval. The agency issued a complete response letter for new drug applications of alogliptin and a combination drug that pairs alogliptin with another Takeda drug, Actos. “We will immediately request a meeting with the FDA to determine the appropriate next steps […]
Takeda Pharmaceutical (TYO:4502) will use biochemical discovery technology from Metabolon to find new therapeutic targets and biomarkers. No financial terms of the research alliance were disclosed. But Metabolon said that the Japanese pharma giant will integrate Metabolon’s biochemical technology into Takeda’s R&D programs with the goal of accelerating development. Metabolon’s platform technology discovers biomarkers, chemical […]
A type 2 diabetes drug hopefully thought of as a potential blockbuster before stalling amid safety concerns is now taking another shot at approval. Takeda Pharmaceuticals (TYO:4502), which is partnered with Morrisville, North Carolina-based Furiex Pharmaceuticals (NASDAQ:FURX) on the diabetes drug candidate alogliptin, has filed two new drug applications for the compound with the U.S. […]