Companies Reveal Likely EU Review Outcomes Against EMA Advice
The European Medicines Agency asks companies to wait until they know for certain whether their marketing authorization applications will be approved or not before making any public announcement. Despite this, some companies go public as soon as they hear an early, but non-binding, verdict. The Pink Sheet looks at the issue of “trend votes” and at the companies who decide not to wait.
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Aducanumab: Biogen Is The Latest Firm To Preempt A Negative EU Opinion On Approval
The EU marketing application for aducanumab is heading for a rejection for Alzheimer’s disease, according to a “negative trend vote” at the CHMP disclosed by the drug’s sponsors.
Two Orphans And An Avastin Biosimilar Among EU Approval Recommendations
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 Pfizer got the OK for one biosimilar but has withdrawn an application for another.
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.