FDA grants expedited status for bluebird bio’s gene therapy – WRAL Tech Wire
WRAL Tech Wire |
FDA grants expedited status for bluebird bio’s gene therapy
WRAL Tech Wire DURHAM – bluebird bio, a gene therapy company with operations in Durham, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for Lenti-D, its potential treatment for a rare and life-threatening neurological disorder … |
Regulatory Focus |
Cancer Cell Therapy Trials Spike in Last Six Months, New Report Finds
Regulatory Focus And three cell and gene therapies have won FDA approval: two Car–T cell therapies, including Novartis’ Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL) and Gilead’s Yescarta … CRI report tracks explosive growth of cell therapies in the global pipeline, as China researchers muscle toward the …Endpoints News |
OncLive |
CAR T-Cell Therapy in DLBCL: Centers of Excellence
OncLive The reason I say that is because chemotherapy tends to deplete normal T cells, and we need normal T cells to generate CAR T cells. If a patient comes after 4, 5, or 6 prior therapies and doesn’t have any peripheral blood lymphocytes to collect, it may … |
OncLive |
Emerging CAR T-Cell Therapies
OncLive Anas Younes, MD: So, when we talk about CAR T cells, it’s a platform. There are 3 different company-sponsored products. There are similarities and some differences. The major similarity between Kite, Novartis, and Juno is that they all target CD19 … |