Keyword: Zolgensma (onasemnogene abeparvovec)
Less than a year after buying a U.S. plant from AstraZeneca, Novartis’ biotech AveXis has it ready for production of its gene therapy Zolgensma.
Novartis plans to give away doses of its $2.1 million gene therapy Zolgensma, but critics are worried about its 'too crude' lottery approach.
Hamstrung by manufacturing issues, Novartis' CAR-T med Kymriah has lagged behind expectations. A new European facility could help its cause.
Roche's risdiplam, a potential 2020 entrant in spinal muscular atrophy, scored a FDA priority review on Monday.
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.