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.’
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.
