Clinical trials of the allergy and asthma treatment omalizumab are placed on hold after two monkey fatalities in a study of rhuMAb-E-26, a second-generation version of Xolair. The termination was also attributed to thrombocytopenia observed in nonclinical toxicology Xolair studies. One Xolair trial on partial hold will continue but will not enroll new patients. A BLA for Xolair has been pending at FDA since late August
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
