Gamida, Teva stem cell venture wins FDA fast track

 For Stem Cell Treatment:

On June 23, Gamida Cell announced that its joint venture with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) received fast track designation from the U.S. Food and Drug Administration (FDA) for its stem cell treatment for cancers of the blood.
Their product, StemEx, is in development as an alternative to bone marrow transplants for patients suffering from leukemia and lymphoma.
The FDA fast track program facilitates the development and shortens the review of new drugs that are developed to treat serious conditions. It is give to drugs with the potential to provide treatment for illness that would otherwise go untreated.
A letter from the American department of health and human services stated, "We are designating as a Fast Track development program the investigation of StemEx (ex vivo expanded cord blood) as a supportive treatment to enhance hematopoietic re-constitution of umbilical cord blood cell transplant to improve 100-day post-transplant mortality in adults and adolescents who receive myeloablative therapy for high risk hematological malignancies."
StemEx employs cells from umbilical cord blood. The product is now in Phase III trials in Israel, the US, and in Europe. StemEx has orphan drug designation in the US and in Europe.