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.’
The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year
