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."
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.
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.
Ionis and Biogen have secured FDA approval for their spinal muscular atrophy drug, working closely with the FDA and tapping into a trifecta of incentives -- including fast-track designation, priority review and orphan drug designation.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Biogen and Ionis Pharmaceuticals could soon deliver the first-ever treatment for spinal muscular atrophy. Meanwhile, carrier screening that could prevent the disorder goes unfunded.