Stemline Therapeutics, Inc.
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A much slimmed-down August agenda for the European Medicines Agency’s drug assessment body, the CHMP, also shows that Janssen has asked for more time to reply to questions about its potential multiple sclerosis therapy, ponesimod.
Although Elonzris, the therapy at the heart of its recent acquisition of Stemline has just been rejected in Europe, Italy's Menarini is pushing on with its expansion in oncology and is paying $30m upfront to get the rights to Radius Health's Phase III hope elacestrant.
The company says its drug has demonstrated a positive benefit-risk profile in primary HLH in a post-approval real-life setting in the US since Food and Drug Administration approval in 2018.
GlaxoSmithKline's first-of-its kind treatment for multiple myeloma is among 11 new medicines that have won an EU approval nod from the European Medicines Agency this week.