Division of Novartis AG
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FDA’s disclosure of data “manipulation” in the application for the SMA gene therapy Zolgensma prompted two immediate inquiries from the US Senate – with very different focuses and potential outcomes.
Democratic senators push data-challenged gene therapy into maw of drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question US FDA's decision to withdraw the proposed rule last year.
Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First
Novartis is in the process of "exiting" the "small number" of scientists involved in the fraud, CEO Narasimhan says.
The Swiss major believes it responded in a timely fashion to data manipulation issues associated with its closely watched gene therapy but CEO Vas Narasimhan's bid to rebuild trust with society has taken a hit.
- Gene Therapy, Cell Therapy
- Large Molecule
- Drug Delivery
- Therapeutic Areas
- Musculoskeletal & Connective Tissue Disorders
- Neurology, Nervous System
- North America
- Parent & Subsidiaries
- Novartis AG
- Senior Management
David Lennon, PhD, Pres.
Brian K Kaspar, PhD, CSO
Andrew Knudten, SVP, Tech. Operations & CTO
Rick Modi, SVP, CBO
James J L’Italien, PhD, SVP, Chief Reg. & Quality Officer
- Contact Info
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