The first
approved cell therapy product in Russia brought about $ 0.5 M USD in revenue last year (personal communication with CEO).
Not exact matches
Still, a few stem
cell therapies have now been
approved, such as a treatment available in India that takes stem
cells from the patient's eye in order to regrow the surface of their cornea, and a US
product based on other people's bone stem
cells.
If CTL019 is
approved, the Swiss pharmaceutical giant plans to dole it out from about 30 preapproved sites, each trained in the multi-step process of harvesting
cells, handling the
product, and treating patients for the feverish and often life - threatening immune response that usually accompanies CAR - T
therapy.
FDA also
approves so - called biologics, which include
products made from human tissues, blood, and
cells, and gene
therapy techniques.
We wanted to take that challenge off the plates of
cell therapy developers so that they could focus on the clinical aspects of the field without having to worry about how to make the
products once they are
approved.