CHMP Delays Review of Portola's Ondexxya; Who Will Pass Muster?
With its final meeting of the year under way, the EMA's medicines evaluation committee, the CHMP, will bring seasonal cheer for some companies if it decides their products merit EU approval. New treatments from Shionogi and Medac are up for an opinion. A planned appearance by Portola before the panel to answers questions relating to its marketing application for Ondexxya/AndexXa has been cancelled and the review period for the marketing authorization application for the product extended.
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Opinions on whether new products for the treatment of conditions such as psoriasis, coagulation reversal, flu and diabetes should be granted an EU marketing authorization are due this week as the EMA’s key scientific committee, the CHMP, meets for the last time in London..
New medicines under evaluation at the European Medicines Agency.
Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP. Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.