Pfizer (NYSE:PFE) is suing Regor Therapeutics, a China-headquartered company that announced a $1.5 billion diabetes alliance with Eli Lilly (NYSE:LLY) in late 2021. Filed in the U.S. District Court for the District of Delaware, Pfizer’s lawsuit also accuses former employees Xiayang Qiu, Min Zhong and 10 unnamed individuals of using its trade secrets as the…
Novo Nordisk to test oral semaglutide as an obesity therapy
Global pharma firm Novo Nordisk (NYSE:NVO) will launch a Phase 3a study to investigate the potential of oral Ozempic (semaglutide) to treat obesity. The drug is currently indicated in a subcutaneous form in the U.S. for people with type 2 diabetes to improve glycemic control in conjunction with diet and exercise and to lower diabetics’…
FDA sends Novo Nordisk refusal to file letter for weekly 2-mg semaglutide
Novo Nordisk announced that the FDA issued a refusal-to-file letter related to its application to expand the label for once-weekly subcutaneous Ozempic (semaglutide). The company had sought to expand the label for a 2.0-mg dose of once-weekly semaglutide to treat type 2 diabetes. It filed the letter on Jan. 20, 2021. The letter indicates that…
Vertex Pharmaceuticals wins FDA fast track designation for its cell-based diabetes treatment
Vertex Pharmaceuticals announced today that FDA has granted fast track designation for its VX-880, an investigational human stem cell-derived islet cell therapy for type 1 diabetes. Vertex has begun a clinical trial for VX-880 (formerly known as STx-02) in patients with type 1 diabetes (T1D) with severe hypoglycemia and impaired hypoglycemia awareness. “Ours is the only…