With the termination of a Phase II trial of LY2887621, Merck’s MK-8931 leads the race to become the first BACE inhibitor approved for Alzheimer’s, although four other companies have similar candidates in earlier stages of development. Lilly says it may continue to pursue BACE inhibition in Alzheimer’s.
Though Eli Lilly & Co.has had to shut down a clinical trial of its BACE inhibitor in Alzheimer’s disease, the company is trying to assure the Alzheimer’s community that the reason is related to the molecule, not the mechanism of action.
Lilly announced June 14 that it was stopping the Phase II BACC trial for LY2886721 because of abnormal liver-function tests in four patients.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
