Kate Rawson
More first-cycle approvals. That’s what every sponsor wants: a better chance of receiving that coveted approval letter on the first...
FDA's Next-Generation Review Process: Avoiding the "Crisis Mentality"
There are changes coming to FDA's drug review process that, over the long term, should make the system more predictable and increase the chances for a first-cycle approval. Until then, expect a less forgiving agency when it comes to incomplete submissions-and challenges that may threaten the sanctity of priority reviews.
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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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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.”
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The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
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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.