NORTHBROOK, Ill., June 10, 2024 /PRNewswire/ -- Astellas is proud to announce that it is coordinating Patient Advocacy Organization (PAO) Action Week™ — a community-driven collaboration comprised of more than 50 healthcare, patient advocacy and other organizations across the U.S. The first-ever PAO Action Week will take place June 10 through June 14 to raise awareness of the invaluable support and resources PAOs offer for patients and caregivers.
Astellas Pharma Inc, a pharma company conducting business in more than 70 countries globally, announced that the US Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational claudin (CLDN) 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy approved for this patient population in the US. Under the Prescription Drug User Fee Act (PDUFA), the US FDA has set a new target action date of November 9, 2024.
Astellas Pharma Inc. has signed a Memorandum of Understanding (MoU) with Yaskawa Electric Corporation to begin discussions on the creation of an innovative cell therapy ecosystem through the integration of pharmaceutical and robotics technologies. This MoU is legally non-binding and will lead to further specific discussions between the two companies in the future.
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