Subsidiary AveXis said the two executives being replaced had not been involved in operations since May and were no longer with the company. Another publication reported that they had been ousted in connection the scandal.
Five Democratic senators - two running for president - wrote in a letter to the FDA's acting commissioner that the scandal highlighted industry "privilege and greed."
A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices.
Novartis CEO Vas Narasimhan said the data manipulation issue was confined to a disused potency assay for use in mice and predated the company's acquisition of AveXis, while trying to reassure analysts that the disclosure delay was for the sake of completing an internal investigation.
In a statement Tuesday, an FDA official wrote that subsidiary AveXis disclosed manipulation of mouse data for the gene therapy Zolgensma, which the agency approved in May for spinal muscular atrophy. The official wrote that civil or criminal penalties were possible.
An analyst wrote that data from the Phase II study of Spinraza show the drug's strength, but that competition from Novartis' recently approved gene therapy, Zolgensma would continue weighing on Biogen's stock.
The gene therapy will be priced at $2.125 million, or $425,000 per year for five years, under an installment-based payment program for which Novartis is partnered with specialty pharmacy Accredo.
When it comes to managing inbound phone calls, underperformance has devastating cost implications.
The AveXis treatment for spinal muscular atrophy type 1 generated positive clinical data from a study in November last year — the 15 infants treated at 20 months with AVXS-10 suffered no adverse events.