CLOZARIL BIWEEKLY BLOOD TESTS WOULD LEAD TO .4 MORE AGRANULOCYTOSIS CASES per 1,000 patient-years after six months of therapy compared to the current weekly blood cell monitoring schedule, according to a registry analysis presented by Novartis to FDA's Psychopharmacologic Drugs Advisory Committee July 14. The committee unanimously recommended the less frequent blood sampling after six months and voted 7-3 to allow monitoring after one year of therapy to be voluntary. No recommendation was made for when to discontinue blood cell counts for the antipsychotic.
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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.’
European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.
Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.
