-
Regeneron's Eylea snags pre-filled syringe approval as Novartis rival looms
fiercepharma
August 14, 2019
Eye med Eylea has been a blockbuster sales force for Regeneron, but Novartis’ challenger brolucizumab is on the horizon. Could a new delivery option give Eylea a leg up?
-
Novartis inspection puts into question who knew what—and when—about Zolgensma data manipulation
fiercepharma
August 14, 2019
Novartis, which last week was publicly shamed by the FDA for manipulating data tied to the application of its gene therapy Zolgensma, has said that it launched an investigation in March, as soon as it learned of the issue.
-
Senate panel launches probe into Novartis' 'reprehensible' response to Zolgensma data irregularities
fiercepharma
August 14, 2019
Novartis caught plenty of flack with last week’s revelation that its FDA application for gene therapy Zolgensma contained manipulated data and that the company didn't inform regulators until after its approval. Now it's facing a congressional investigatio
-
Sanders, Warren join team of senators blasting Novartis' Zolgensma data rig
fiercepharma
August 14, 2019
U.S. Sens. Bernie Sanders and Elizabeth Warren have been harsh critics of the pharmaceutical industry in general. Now they've joined hands with three other senators to go after one pharma company in particular.
-
US Senator seeks records linked to Novartis’ Zolgensma data issues
pharmaceutical-technology
August 14, 2019
The US Senate Finance Committee Chairman Chuck Grassley has asked Novartis to provide information on data manipulation issues related to the company’s subsidiary AveXis’ spinal muscular atrophy (SMA) drug Zolgensma.
-
Novartis could face legal action over Zolgensma application
europeanpharmaceuticalreview
August 09, 2019
The pharmaceutical company failed to inform the FDA of manipulated data when the gene therapy was under review and could face a legal battle.
-
Novartis defends Zolgensma in face of FDA’s data concerns
pharmaceutical-technology
August 08, 2019
The US Food and Drug Administration (FDA) has issued a statement regarding data accuracy issues related with Novartis’ biologic license application (BLA) for gene therapy Zolgensma (onasemnogene abeparvovec-xioi).
-
Novartis, Mundipharma ink partnership to enhance access to three Asian countries to established medicine brands for glaucoma and external eye diseases
prnasia
August 06, 2019
International healthcare organizations, Novartis and Mundipharma, have signed a landmark agreement for the marketing, sales and distribution rights of Novartis medicines in
-
AstraZeneca and Novartis set to lose out from US drug prices reforms
europeanpharmaceuticalreview
July 31, 2019
A report has suggested that the drug price reforms in the US will affect AstraZeneca and Novartis negatively, but Novo could benefit.
-
Novartis reclaims sterile products plant in Canada after sale goes south
fiercepharma
July 28, 2019
Call it a marriage gone bad. Novartis is expected to soon regain control of the Sandoz Boucherville sterile drug manufacturing site in Canada that it sold to Avara Pharmaceuticals last year. It turns out the relationship went bad almost as soon as it was