AOP Orphan Pharmaceuticals AG
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Latest From AOP Orphan Pharmaceuticals AG
Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019.
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 Pfizer got the OK for one biosimilar but has withdrawn an application for another.
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.
CTI BioPharma has had a bumpy ride with pacrotinib, its investigational treatment for patients with myelofibrosis who have thrombocytopenia. But it has persevered and should learn this week whether the European Medicines Agency will recommend that the product be approved for the sale across the EU. Pacritinib, J&J's apalutamide, and AEterna Zentaris's macimorelin are among a handful of products reaching the end of the approval process.
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- Rigi Orphan Inc, USA