Regulatory
In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.
Sio Gene Therapies had a few big announcements last week, including a Fast Track Designation from the U.S. Food and Drug Administration and the reorganization of its R&D group.
The U.S. FDA has a busy period at the end of October heading into the first week of November.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
The upcoming changes will be less disruptive but will have far-reaching consequences throughout the pharmaceutical supply chain.
An experimental AstraZeneca cancer drug trial has been placed on hold due to safety concerns. This news comes two years after Amgen was also forced to pause a study of a drug within the same class.
The experimental drug, NTLA-2001, is being developed for the treatment of transthyretin (ATTR) amyloidosis.
More than $170 million was paid out for drugs that manufacturers voluntarily withdrew from the market after subsequent trials showed no benefit in overall survival.
The concern relates to the risk of two rare heart inflammation conditions, myocarditis and pericarditis, that have been linked to the Pfizer and Moderna mRNA vaccines.
PRESS RELEASES