The EMA and the FDA released a draft joint proposal to facilitate multi-arm, multicompany clinical trials for pediatric treatments of Gaucher disease. The proposed approach would determine the safety and efficacy of several new medicines at the same time, reducing the total number of children enrolled since all the therapies would be evaluated against one control group. If successful, this concept could be used to develop multiple drugs for other rare diseases in a reduced time frame and with limited enrollment.

The FDA released the latest installment in its series of draft biosimilar guidances. It discusses the design and use of clinical pharmacology studies. Pharmacokinetic and pharmacodynamic data are required as part of the FDA's stepwise approach to demonstrating biosimilarity to the reference drug. The draft guidance identifies three key concepts – exposure and response assessment, evaluation of residual uncertainty and assumptions about analytical quality and similarity – as especially relevant to the development of biosimilars.

The Federal Trade Commission (FTC) is once again proposing a study of patent assertion entities, also known as patent trolls, and their impact on innovation and competition. The FTC first proposed the study last year. After reviewing 70 comments on the study plan, the commission revised the study to sharpen its focus and reduce the burden on participants.

The EMA issued an update on joint U.S.-European efforts to tackle the rising tide of antimicrobial resistance, detailing progress in converging the EMA and FDA regulatory requirements in the development of new antibacterial drugs. The move to merge regulation in that area sits under the umbrella of the Transatlantic Taskforce on Antimicrobial Resistance, established between the European Commission and the U.S. Department of Health and Human Services, to act together in fighting drug-resistant pathogens.