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 European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
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The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
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The European Medicines Agency has recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy, despite the product securing approvals in the US and other markets.