FDA’s Reproductive Health Products Advisory Committee meeting on Amgen’s osteoporosis drug could have derailed denosumab’s prospects at a number of key turning points. But Amgen’s presentation combined with the drug’s effi cacy profi le pushed the investigational product through a key regulatory toll gate relatively unscathed.
Ramsey Baghdadi
FDA's advisory committee meeting reviewing the marketability of Amgen Inc.'s osteoporosis drug denosumab (Prolia) was one of the most important...
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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 EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
