No­var­tis makes new da­ta in­tegri­ty com­mit­ment

Look­ing to slow the fall­out from No­var­tis’ da­ta ma­nip­u­la­tion fi­as­co with its bil­lion-dol­lar gene ther­a­py Zol­gens­ma (onasemno­gene abepar­vovec-xioi), CEO Vas­ant Narasimhan told an in­vestor con­fer­ence on Mon­day that the com­pa­ny will be more proac­tive in re­port­ing da­ta in­tegri­ty is­sues to the FDA.

“We are vol­un­tar­i­ly and proac­tive­ly tak­ing a pledge with the FDA to en­sure that we will in­form them with­in five busi­ness days of any cred­i­ble al­le­ga­tion re­lat­ed to da­ta in­tegri­ty,” Narasimhan said.

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