Tuesday, the FDA approved Amgen Inc (NASDAQ:AMGN) Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca Plc’s (NASDAQ:AZN) Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-medi
AstraZeneca's (AZN) shares decline as it fails to achieve statistically significant overall survival data in a late-stage NSCLC study on Dato-DXd compared with docetaxel.
On Tuesday, AstraZeneca Plc (NASDAQ:AZN) said the survival results did not reach statistical significance in the overall trial population in the TROPION-Lung01 phase 3 trial. Topline overall survival (OS) results from the TROPION-Lung01 phase 3 trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favored datopotamab deruxtecan (Dato-DXd) compared to docetaxel for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients treated wi