Stemline Therapeutics, Inc.
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Latest From Stemline Therapeutics, Inc.
Two years into her tenure as the head of Menarini, Elcin Barker Ergun has already inked two major cancer deals with the acquisition of Stemline and a key licensing pact with Radius Health. The future for the Italian group is bright, she explained to Scrip in an exclusive interview.
Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.
The EU’s special provisions for speeding new products towards approval proved more popular than ever with drug sponsors last year.
Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.