The U.S. Federal Trade Commission said it has closed its investigation into the acquisition of Takeda Pharmaceutical’s Tachosil fibring sealant surgical pack by Johnson & Johnson, of New Brunswick, N.J. FTC chairman Joseph Simons said the agency’s investigation disclosed that the two companies were the only firms in the surgical sealant patch market, and that the decision by the companies to cancel the deal ensures that patients will continue to “benefit from the competition between these life-saving devices.”
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) updated its Q&A guidance on how to manage clinical trials during the COVID-19 pandemic. The guidance provides information on alternative measures that can be used when a process predetermined in the study protocol is not deemed feasible due to COVID-19, such as when participants can’t visit the site to receive study drugs, devices or other products used in the trial. “In any situation, protection for the safety of trial participants should be given first priority, and any changes/deviations from the study protocol should be well documented,” the PMDA said. The agency also is allowing institutional review boards (IRB) to meet via email or virtually when an immediate meeting is necessary to enable a quick start of clinical trials for COVID-19 products. The actual process and conduct of such meetings should be well noted, the agency said.
The U.S. National Institutes of Health said it has commenced enrollment in a study to determine how many Americans have antibodies for the SARS-CoV-2 virus despite lack of a confirmatory diagnosis of COVID-19. The study, which is recruiting at the agency’s headquarters in Bethesda, Md., will enroll 10,000 and make use of antibody tests in this “serosurvey” study. The study will employ ELISA testing and check for two immunoglobulins associated with the pathogen, immunoglobulins G and M. Participation is limited to those who are aged 18 and older, who will be consented over the phone and complete a virtual clinical visit.