EU Firsts For CAR-T & PRIME As EMA Grants Kite Accelerated Assessment
Kite Pharma claims it has filed the first EU application to market a CAR T-cell therapy, and says that being on the European Medicines Agency’s PRIME scheme was helpful when it came to getting answers to the questions it had on the application.
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Kite and Novartis are vying to be the first company to have a CAR-T therapy approved in the EU. Both companies are hoping to be able to treat patients with r/r DLBCL.
The US has plenty of new pharma legislation, Europe has plenty of worries about EMA's Brexit move, pharmacy benefit managers give plenty more scrutiny to which products earn a place on formulary. Policy Prescriptions rounds up recent regulatory news and trends reported by sister publication the Pink Sheet.
Brain tumors now equal lymphoma as the most common type of cancers being targeted by oncology products on the European Medicines Agency’s priority medicines (PRIME) scheme for getting medicines for unmet medical needs to patents faster.