US FDA places a hold on a clinical study testing Novartis’ Zolgensma in patients with SMA Type 2, after information provided to the authorities by AveXis.
AveXis and BIA Separations announce an agreement for the commercial purification process of SMA gene therapy drug Zolgensma and further gene therapy candidates.
Catalent Biologics works with Novartis to develop and manufacture its SMA gene therapy treatment and provide manufacturing capacity, as the treatment enters the market.
Novartis receives US FDA approval for its gene therapy, Zolgensma, which is a treatment for spinal muscular atrophy, and prices the drug at $2.1m per patient.
Novartis investigates the death of an infant in a gene therapy clinical trial to determine whether it was related to the treatment but does not anticipate an impact on FDA approval.