Tag Archives: Novartis

New Zolgensma ‘inflection point’ is here as Novartis snags EU nod for SMA gene therapy

As the number of U.S. spinal muscular atrophy (SMA) patients Zolgensma treats each quarter stabilizes, Novartis is counting on a set of “inflection points” for future growth. Now, it has one. After a manufacturing-related delay, Novartis has won conditional approval in the EU for the one-time gene therapy to treat patients with a clinical diagnosis… Read More »

FDA says some data testing Novartis’ $2 million gene therapy was manipulated

NEW YORK (Reuters) – The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis’ more than $ 2 million gene therapy Zolgensma was manipulated, but the agency believes the treatment should remain on the market. FILE PHOTO: The headquarters of the U.S. Food and Drug Administration (FDA) is… Read More »

Novartis building out cell and gene therapy platform that'll lead the pack, CEO promises

SAN FRANCISCO—Novartis’ first-ever CAR-T cell therapy may have been hamstrung by early manufacturing problems, but the company still figures it can build a cell and gene therapy platform strong enough to deliver success not only with Kymriah but also a full “game board” of treatments for many more diseases, its CEO said on Monday. During his first… Read More »