Top Regulatory News Stories – Week Ending May 31, 2019

AveXis/Novartis received FDA approval for Zolgensma, the gene therapy for children younger than two years old who have been diagnosed with SMA with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. The therapy will be available to patients for a cost of $2.125 million, or $425,000 per year for 5 years.  https://www.biospace.com/article/novartis-sma-gene-therapy-treatment-approved-by-the-fda-will-have-a-price-of-2-125-million/ Novocure[…]