It isn’t often that a single company has an advisory committee meeting for one product and an FDA decision for another in the same week. Even more unusual is when the two drugs are of the same therapeutic class. That’s what’s happening this week for Bristol Myers...
The European Medicines Agency (EMA) has recommended broadening the use of Johnson & Johnson (J&J) and Legend Biotech’s CAR-T therapy, Carvytki, to include earlier treatment stages for patients with relapsed or refractory multiple myeloma. This...
Atara Biotherapeutics, a leading entity in T-cell immunotherapy, has achieved a significant milestone with the FDA clearance of its Investigational New Drug (IND) application for ATA3219, a novel allogeneic, anti-CD19 chimeric antigen receptor (CAR) T-cell monotherapy...
Astellas is penning a deal with Kelonia Therapeutics to develop in vivo cell therapies to treat cancer, but with a twist. Not only would the treatments be off-the-shelf, meaning that they would not have to be tailored to each patient as current CAR-T therapies are,...
Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will...
