New EU Approvals
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).
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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 firm reorganized to focus on hemoglobinopathies and cancers after Celgene ended a multi-drug partnership. Also, Flagship funds a gene therapy start-up and brings in a business development veteran, Ultragenyx raises $320m in a royalty deal and Paratek secures up to $285m from BARDA.
The Therapeutic Goods Administration said its decision to down-schedule two psychedelic substances to controlled drug status followed extensive public consultation, a report from an independent expert panel, and advice from the Advisory Committee on Medicines Scheduling.