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Stemline Therapeutics, Inc.

https://stemline.com/

Latest From Stemline Therapeutics, Inc.

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

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.

Approvals Review Pathway

EMA Doubles Number Of EU Early Access Approval Recommendations

The EU’s special provisions for speeding new products towards approval proved more popular than ever with drug sponsors last year.

Europe Approvals

Elzonris: A Case Study In Divergent Regulatory Decisions

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.

Drug Review Profile Europe

Asia Deal Watch: Vibegron’s Vagabond Journey Continues With Eisai Acquiring Partial Asian Rights

Kyorin, Eisai build on earlier OAB deal to team on vibegron. Plus deals involving Piramal/Hemmo, ImmuneOncia/3D Medicines, Kyowa Kirin/Cerecor, Simcere/Kazia, Nippon Shinyaku/Menarini, Tarsus/LianBio

Deals M & A
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