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.’
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European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.
