Senators urge action in Novartis gene therapy data manipulation 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."
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."
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.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.