Stemline And Karyopharm Want More Time At EMA
The CHMP Stiil Has Issues Over Filings For Tagraxofusp And Selinexor
A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.
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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.
There is speculation that it is the end of the road for abicipar pegol but Allergan has declined to say whether this is the case for the product that has been in development for wet AMD.
Novartis recognized it would not be able to answer objections relating to its EU marketing application for the dry eye drug, Xiidra (lifitegrast), and so it has withdrawn the application. The company last year paid upwards of $3bn for the drug, which is already marketed in the US and other markets.