Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
Tag Archive for: Astellas
Today, a diagnosis of Pompe disease ties people to twice-monthly infusions of enzyme replacement therapy. Astellas is trying to change that with AT845, a gene therapy that would serve as a one-time treatment for patients with LOPD.
Monday, Astellas named a new president and CEO and announced additional changes to its leadership structure in an effort to accelerate growth and chart its long-term business trajectory.
The FDA put 4D Molecular Therapeutics’ gene therapy program, 4D-310, on clinical hold, the company announced February 2.
A group of 25 senators, led by Sen. Elizabeth Warren (D-MA), requested that HHS Sec. Xavier Becerra exercise march-in rights for Xtandi, a prostate cancer therapeutic. March-in rights give the government the right to take a license for itself if it helped to fund the product owner’s research.
Yesterday, Astellas announced that the FDA had lifted its clinical hold for the company’s experimental gene therapy trial for late-onset Pompe disease. The therapy was placed on clinical hold in June 2022 after a study participant experienced a severe adverse event.
The four companies will share knowledge on packaging technologies to reduce environmental burden, such as blister packs made of biomass-based plastic instead of petroleum-derived plastic, compact packaging, recycled packaging materials, and recyclable packaging materials.
Astellas Pharma Inc. President and CEO Kenji Yasukawa, Ph.D., today announced the opening of a new late-stage clinical and commercial manufacturing facility in Sanford, N.C. The facility will allow Astellas Pharma to expand the company’s resources and team to establish a robust, global supply chain and expand its therapeutic and geographic scope.