The company announced positive results in the second population of its Phase II study of dazodalibep in patients with Sj

FDA officials question whether modeling tools can predict which drugs have different disposition in obese populations. They say physiologically-based pharmacokinetic data cannot be used as a surrogate for actual clinical trial data at this time.

The director of the agency’s patient-focused drug development program talks about how the program has improved the development and evaluation of new drugs, initiatives underway, and plans to standardize and harmonize the process.

The US major has announced its biggest acquisition to date in the form of a takeover that should expand its rare disease franchise and stave off concerns about internal products facing biosimilar competition.