Evive meets in Phase III for chemotherapy-induced neutropenia; plus regulatory updates for Biogen, Eisai, Merck, AZ

Evive planning BLA, MAA for neutropenia therapy following pivotal trial readout
Evive Biotech Inc. said efbemalenograstim alfa met the primary and secondary endpoints in a Phase III study to prevent chemotherapy-induced neutropenia in breast cancer patients. The long-acting dimeric fusion protein containing G-CSF and an IgG2 Fc fragment was noninferior to standard-of-care treatment Neulasta pegfilgrastim. The company plans to submit marketing applications in the U.S. and EU.

Aducanumab BLA submission for Alzheimer’s completed
Biogen Inc. (NASDAQ:BIIB) and Eisai Co. Ltd. (Tokyo:4523) completed a BLA submission for aducanumab to treat Alzheimer’s disease. Biogen had planned to submit the application early this year but in April disclosed the submission would be delayed to this quarter. CEO Michel Vounatsos cited the complexity of the data package for the anti-β amyloid mAb as the reason for the push back (see “Aducanumab Filing Delayed”)...