Keyword: Zolgensma (onasemnogene abeparvovec)
Novartis'AveXis knew of the Zolgensma spinal-injection safety signal that led to a recent FDA clinical hold since March, but left it out "by mistake."
The FDA halted enrollment in one arm of the phase 1/2 Strong trial, which is testing Novartis' gene therapy Zolgensma as a spinal injection.
FTC review delays Sandoz-Aurobindo generics deal. Manufacturing questions push back Zolgensma decision in Japan. AZ expects mid-teens China growth.
Novartis' effort to cut up to $2 billion out of production units will play out next at its site in Cork, Ireland.
Novartis’ Zolgensma launch has been anything but boring: First a record price, then a data scandal and now a manufacturing-related delay in Europe.
Zolgensma hauled in $160 million in its first full quarter on the market, more than 60% above the Street's expectations.
Novartis is touting data showing dramatic improvements after treatment with Zolgensma for SMA patients between ages 2 and 5.
JPMorgan discovered concerns about the efficacy of Novartis' Zolgensma that could make it difficult for the SMA gene therapy to meet expectations.
Novartis is putting the quality teams at gene therapy biotech AveXis under parental control after being embarrassed by a data manipulation scandal.