No­var­tis-backed Gami­da Cell grabs a break­through tro­phy for ex­per­i­men­tal cell treat­ment

Is­rael’s Gami­da Cell is get­ting flagged to the in­side reg­u­la­to­ry track at the FDA. The agency has hand­ed the com­pa­ny – which in­cludes No­var­tis as a promi­nent in­vestor – its break­through drug des­ig­na­tion for a top prod­uct in de­vel­op­ment, in­tend­ed to pro­vide an open door to the agency to help speed along the ap­proval process.

BTDs are be­com­ing quite com­mon at the FDA. And this time its spe­cial sta­tus is be­ing ap­plied to NiCord, which is be­ing de­vel­oped as a re­place­ment for bone mar­row trans­plants.

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