Amendment to Genentech/Novartis' Xolair (omalizumab) BLA will be submitted by year-end, with an expected six-month review from FDA, Genentech tells analysts. The amendment will include data from the firms' 1,900-patient safety study, ALTO, bringing the total safety database to over 4,000 patients. FDA had deemed the size of the Xolair safety database inadequate and requested platelet monitoring safety data from ALTO, as well as data on subgroups and pharmacokinetics. The BLA, submitted in June 2000 for moderate to severe allergic asthma in adults and adolescents, received a "complete response" letter in July 200
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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 European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
