Keyword: European Medicines Agency
Staff will move into the offices throughout the coming week having left the U.K. as it enters a critical moment in the Brexit process.
The submission comes a year after Celgene received an embarrassing refuse-to-file letter for ozanimod from the FDA.
The biotech took the action after learning that the CHMP was likely to advise against approving the oral kinase inhibitor.
The biotech said it withdrew the submission for C5aR antagonist avacopan as it now expects to have the data to file for a full approval next year.
CMO Sean Bohen and I-O head David Berman are leaving AstraZeneca, while Roche's Omar Khwaja and Pearl Huang land at new biotechs.
More than 900 days have passed since the U.K. voted to leave the EU, but the outlook today is more uncertain than on any of the preceding 900 days.
Xenon Pharmaceuticals is taking a stab at repurposing GlaxoSmithKline's ezogabine for a rare, difficult-to-treat form of pediatric epilepsy.
The European Medicines Agency has begun laying the foundation for its new Amsterdam headquarters, aiming to finish construction by November 2019.
The EMA has mapped out a path to approval for Auris’ acute hearing loss treatment after the drug failed in phase 3 late last year.
The proposal jibes with the wishes of the biopharma industry, but it remains to be seen whether the European Union is receptive to the idea.