New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
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A PFS benefit and favorable tolerability profile associated with AstraZeneca’s BTK inhibitor acalabrutinib used first-line in CLL, when given alone or combined with obinutuzumab, may serve it well against entrenched competitors and BTK inhibitors in clinical development.
The European Medicines Agency has received 11 new marketing authorization applications, including three for orphan products from Vertex, MYR Pharmaceuticals and AstraZeneca.
While inspection interviews can be stressful for drug firms, a Dutch pharmacovigilance inspector reassures companies that any responses made during the process cannot undo any good work they have already done. And they can also correct any wrong answers later on.