The companies announced they will advance the development of CK-2127107 (a fast skeletal troponin activator) into Phase II clinical trials for the treatment of spinal muscular atrophy and possibly other neuromuscular conditions.
[14] In November 2017, the company announced that it exercised an option to purchase Cambridge, Massachusetts-based Mitobridge, which is developing treatments for Duchenne muscular dystrophy and age-related diseases.
[22][23] Audentes will operate as a wholly owned subsidiary within Astellas, and will serve as the Center of Excellence for the newly created Genetic Regulation Primary Focus, providing leadership for AAV pipeline advancement through commercialization, manufacturing expansion, and next-generation research initiatives.
[24] The acquisition includes Astellas gaining Xyphos’ Advanced Cellular Control through Engineered Ligands (ACCEL) technology platform.
[29][30] In November, Astellas announced it would acquire Propella Therapeutics, Inc. and its lead androgen biosynthesis inhibitor abiraterone decanoate (PRL-02) used to treat prostate cancer.
[31][32] The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list): In June 2016, the Association of the British Pharmaceutical Industry (ABPI) gave Astellas a year-long suspension, after complaints it had "purposely misled the PMCPA.
[34] In May 2017, the ABPI extended the suspension by a further 12 months, based on findings that Astellas was not adequately overseeing and training nurses, and that it had failed to provide complete prescribing information for several medicines.
In April 2019, Astellas agreed to pay the United States Department of Justice $100 million to resolve allegations that it had conspired to offer kickbacks via Medicare copay foundations.
Zolbetuximab is the first treatment of its kind in the region, and a decision on its approval is expected by 12 January 2024, based on the Phase III SPOTLIGHT and GLOW clinical trial results.
[40][41] In 2007, the company narrowed UK distribution of Advagraf and Prograf to a sole distributor, UniChem, in reaction to pharmacist complaints about drug availability from wholesale sources.