Novartis AveXis President Lennon On Rebuilding Trust With FDA, Zolgensma Trial Hold, And More
AveXis President David Lennon talked to Pink Sheet about quality enhancement at the gene therapy unit, a clinical trial hold for Zolgensma in Type 2 SMA, and expansion in gene therapy.
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Daily round-up from the J.P. Morgan Healthcare Conference in San Francisco: There was no big M&A, but biopharma CEOs discussed deals they're pursuing. Also, Novartis's Zolgensma reimbursement insights, Sarepta's third DMD filing, Bristol's post-merger progress and more highlights.
Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.
The total cost of Zolgensma is more than $2m – in line with estimates – or $425,000 annually for five years if payers choose an annuity-like payment plan. Novartis is also negotiating value-based reimbursement agreements for infants treated with the one-time infusion.