Tampere

Xbrane Biopharma has received scientific advice from the US Food and Drug Administration (FDA) on the development of its Opdivo biosimilar candidate Xdivane.

AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting based on the positive results from the DESTINY-Breast06 Phase III trial which compared Enhertu to chemotherapy.

The Board of Directors of Spago Nanomedical has decided that the company’s resources will be focused on the development of Tumorad with the company’s primary priority being the execution of the ongoing clinical study Tumorad-01 with the candidate drug 177Lu-SN201.