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Improving quality control for CAR T cell therapies

Drug Discovery World

But decades of research led to improvements in cancer therapy, centred around the idea that one’s immune system could aid in treatment. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic.

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Article FDA Thank You House legislators set to markup legislation related to rare diseases, pediatric oncology and HCT/Ps

Agency IQ

At that time, the FDA would no longer be able to award new vouchers to companies, unless the product already had rare pediatric disease designation, and obtained approval before October 1, 2026. Combination products could include standards of care or other therapies owned by the same sponsor as the primary drug.

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Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

“We are excited to be nearing the EMA’s regulatory decision on VASCEPA and are busy preparing for our anticipated commercial launch in Europe, where there is a large and growing opportunity for Amarin to bring this proven effective therapy to the millions of patients at high risk for cardiovascular events. 500 mg/dL) hypertriglyceridemia.