Two former Spero Therapeutics Inc. executives are on the hook for a total of $187,500 in civil penalties in a settlement resolving U.S. SEC allegations of issuing misleading statements centered on the FDA’s evaluation of Spero’s lead drug candidate that resulted in a 64% stock drop in May 2022.
The U.S. Department of Justice said recoveries under the False Claims Act in fiscal year 2025 reached a record of more than $6.8 billion, more than 80% of which came from health care cases.
The range of effects caused by rhinoviruses – the pathogens responsible for the common cold – motivated scientists at Yale University to study the human nasal epithelium and uncover a previously undescribed defense mechanism. The interferon-mediated protective response in these cells can limit infection, whereas a maladaptive response tends to worsen it. Based on these findings, the researchers have identified potential therapeutic targets to reduce inflammation associated with rhinovirus infection.
A new systematic review and meta-analysis of studies looking at a possible association between Tylenol (acetaminophen) use in pregnancy and neurodevelopmental disorders in children concludes there is no evidence of any meaningful risk. The study was carried out by researchers in the U.K., Italy, Sweden and Norway, in response to U.S. Secretary of Health and Human Services Robert Kennedy saying last September that there is a link. Unless medically necessary, it is “irresponsible” to take Tylenol during pregnancy, Kennedy said.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Adolore, Eli Lilly, Sanofi, Santhera.