Stemline Has What It Takes On EU Fast-Track Front
There's good news for Stemline Therapeutics on the EU fast-track front. At least three other companies, though, have had their requests rejected in recent months and Novartis is not saying whether a request it made was successful or not.
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In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.
The CEO of French firm Advicenne explains why the company did not win an accelerated EU assessment for its kidney disease drug ADV7103, and why it may well try again in future with another indication – and perhaps with other new drugs too.
The European Medicines Agency is this week deciding whether it will fast track its review of orphan drugs that Novartis is developing for the treatment of Cushing's syndrome and Stemline Therapeutics is developing for the hematologic malignancy, BPDCN.