STAT+: Pharmalittle: We’re reading about a Novartis gene therapy, faster U.K. drug reviews, and more — SkimNews
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- Novartis acknowledged seven previously unknown instances of tumors in children who received its spinal muscular atrophy therapy, raising concerns among families, physicians and patient advocacy groups.
- The seven cases are being seen for the moment only as a potential safety signal.
- Novartis disclosed the information to neurologists earlier in the week before an advocacy group and a Facebook page publicized the cases Thursday.
- SMA Europe said regulatory authorities are now examining the cases.
Why it matters: For Novartis, seven acknowledged pediatric tumor cases among children who received its SMA therapy create a concrete regulatory-review issue, with SMA Europe saying authorities are now examining them. Families, physicians and patient advocacy groups have seven specific cases to assess, although the cases remain only a potential safety signal.
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