No­var­tis man­u­fac­tur­ing fa­cil­i­ty in North Car­oli­na gets FDA all-clear to pro­duce, ship gene ther­a­pies

Just one day af­ter Vas Narasimhan an­nounced $1 bil­lion in cuts amid a com­pa­ny-wide re­struc­tur­ing, the Amer­i­can-Swiss phar­ma re­ceived FDA clear­ance to pro­duce its spinal mus­cu­lar at­ro­phy drug Zol­gens­ma out of its North Car­oli­na man­u­fac­tur­ing fa­cil­i­ty.

The phar­ma made the an­nounce­ment ear­li­er Tues­day, which al­lows the mas­sive, 170,000-square-foot fa­cil­i­ty to make the drug — along with test­ing and ship­ping it. The com­mer­cial li­cen­sure is not just lim­it­ed to Zol­gens­ma, ac­cord­ing to No­var­tis — the plant will al­so have the abil­i­ty to pro­duce cer­tain gene ther­a­py prod­ucts for use in clin­i­cal tri­als.

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