On April 22, 2024, the PTAB issued final written decisions in IPR2023-00070 and IPR2023-00074, filed by Bluebird Bio on two patents related to recombinant lentiviral vectors — U.S. Patent Nos. 7,541,179 and 8,058,061, owned by Sloan Kettering Institute for Cancer Research. The PTAB ruled that all challenged claims of the…
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…
On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA. SCD is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. and inducing a median life…