Kite Exec Highlights Hospital Role In Cell Therapy Quality Chain
Hospitals will have a large role in success of these treatments, with a high level of teamwork and coordination required between the technical operations team and the commercial teams working in tight time-frames.
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As the first company with two approved chimeric antigen receptor T-cell therapies, Gilead’s Kite subsidiary has set a precedent by keeping the pricing the same as its first approved CAR-T, Yescarta.
Seven pharmacies have filed a lawsuit against the FDA claiming the agency exceeded its statutory authority in its final standard memorandum of understanding on interstate compounding and that the MOU will have an adverse impact on compounding pharmacies and patients.
US pharmacy group says that 10 to 12 states have indicated through an informal survey that they do not have the manpower or funding to implement the US FDA’s final MOU on inordinate compounding. They say what is at stake in these states is patient access to compounded medicines.