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Supplemental New Drug Application for IMBRUVICA™ (ibrutinib) submitted to the U.S. FDA

9 April 2014 | By Johnson & Johnson

Janssen Research & Development, LLC (“Janssen”) today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. This regulatory submission is based on data from the Phase 3 RESONATE™ study in relapsed or…

EMA and Australian regulator strengthen collaboration in the area of orphan medicines

7 April 2014 | By The European Medicines Agency

In a meeting at the European Medicines Agency on 4 April 2014, the EMA’s Executive Director, Prof. Guido Rasi, and the National Manager of the Australian Therapeutic Goods AdministrationExternal link icon, Prof. John Skerritt, announced that the two regulators have agreed to share the full assessment reports...