Two Phase III trials testing the oral JAK inhibitor in ulcerative colitis met their primary endpoints, but Pfizer is awaiting the results of another Phase III maintenance study before filing for a label extension.
Pfizer Inc. released positive Phase III data from two induction trials testing its oral Janus kinase inhibitor Xeljanz (tofacinitib) in patients with the inflammatory bowel disease ulcerative colitis, but the company will await the results of ongoing Phase III studies before filing for an indication expansion.
The company announced the top-line results from the first two trials Sept. 21.
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
