Latest From Theratechnologies Inc.
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.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Astellas Pharma's Xospata (gilteritinib) for treating relapsed or refractory acute myeloid leukemia. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
Companies pleased at gaining an EU accelerated assessment for a product should be aware that the agency offers no guarantee that they will get to keep it. Novartis’s Zolgensma is one of seven drugs whose review the EMA has taken off the fast track.
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