Santa Monica, California-based Kite Pharma has jumped the Atlantic to file the first Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for a CAR-T therapy.
A 10-person panel of experts has unanimously recommended FDA approve a pioneering CAR-T therapy from Novartis, CTL019, for patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL).
A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices.
Novartis announced Wednesday that the FDA has accepted a finalized biologics license application for its lead CAR-T candidate, CTL019, topping it off with a priority review to expedite the process.
One of the biggest biotech buzz fields in recent years, CAR-T immunotherapy is on the cusp of gaining an FDA approval. There is no precedent for what comes next. On Wednesday, we got an early glimpse as Kite Pharma outlined its commercialization plan in a packed presentation at #JPM17.
It's not all doom and gloom for CAR-T immunotherapy. One week after the death of two patients in a trial by Juno Therapeutics, early-stage competitor bluebird bio has released positive interim results for its Phase 1 trial.
The company also just acquired Israel-based Applied Immune Technologies, meant to fine tune its development of monoclonal antibodies.
Transitioning to PDPM models significantly shifted the healthcare industry. By replacing the RUG system, healthcare providers cut waste and more accurately reflect the care each patient received.