EU 2019 Approvals: Novel Therapies Make Strong Showing
Firsts Include Ebola Vaccine And Tumor Agnostic Therapy
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.
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The latest drug development news and highlights from our US FDA Performance Tracker.
The European Commission has granted a marketing authorization for UCB and Amgen’s bone-building MAb, romosozumab, and first launches are expected in the first half of 2020; patient groups suggest that the prevention and treatment of fragility fractures has not attracted the attention it deserves.
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with two new products including Merck Sharp & Dohme's Ebola vaccine, Ervebo. 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).