Health Care & Insurance  September 30, 2019

AveXis to implement data integrity regime in Longmont plant

LONGMONT  — AveXis Inc., the Chicago-area gene therapy company opening a 692,000-square-foot plant in Longmont, is setting up a company-wide data integrity system in its plants after a data manipulation scandal rocked it and its parent company.

In filings released last week by the U.S. Food and Drug Administration, AveXis and its parent company Novartis AG (NYSE: NVS) will implement “compliance action plan” measures at the Longmont plant and its existing Durham, N.C., plant by bringing its quality control plans to those held at Novartis’ corporate-level standards.

The company will also set up stricter data reporting…

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