Eisai/Biogen’s Alzheimer’s drug has fallen foul of a recent court ruling over the handling of the European Medicines Agency’s experts' competing interests.

The EU regulatory agency’s discussions for lecanemab’s approval are hit by a decision to annul advice from an advisory committee due to the implications of a Court of Justice ruling on the handling of experts' competing interests.

The sports medicine market comprises a number of product segments, many of which span several different orthopedics specialties.This space is expected to experience strong growth going forward as companies develop innovative ways, including some lower-cost approaches, to treat the joint and soft-tissue injuries commonly suffered by athletes and other sports enthusiasts.

The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we cover FDA’s proposed comprehensive postmarket surveillance strategy, as well as updates on proposed 510(k) reforms and device user fees.