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.
The race to market CAR T-cell therapies in Europe appears to have moved up a gear – as has the European Medicines Agency’s PRIME (priority medicines) scheme – after Kite Pharma claimed it had submitted the first EU marketing authorization application for such a product and had been granted accelerated assessment under PRIME.
Kite’s announcement on July 31 relates to its CAR (chimeric antigen receptor) T-cell therapy axicabtagene ciloleucel for treating lymphomas
US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.
Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.
The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.
