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Novartis reports seven newly disclosed tumor cases among Zolgensma patients

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Novartis says it has received nine reports of tumors in patients previously treated with Zolgensma since the spinal muscular atrophy gene therapy was first approved in 2019. Seven of the reports were newly disclosed. In two cases, analyses found evidence that the therapy’s viral vector DNA had integrated into patients’ DNA. Novartis said both patients received treatment for their tumors and are being monitored. The other seven reports have not been established as caused by Zolgensma. The company says a possible tumor risk from vector integration is already described in the prescribing information; regulators are examining the reports. The disclosure has prompted concern among families and patient advocates. News reports say Novartis has reported the cases to health authorities and will continue working with them. Sources: Novartis confirms 9 reported cases of tumors linked to spinal muscular atrophy therapy Zolgensma Novartis cites previously unknown tumor cases possibly ti...

GeneDx and Mirum launch no-cost genetic testing programs

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Inovia Bio launches InovaMine for clinical data analysis and drug development

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AstraZeneca reportedly offers about $10B for Rhythm

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Evommune licenses Hinova’s VAV1 drug candidate in deal worth up to $1.1 billion

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RASONQUE brings in nearly $198 million in its first five weeks

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Minghui licenses Japan rights to TED drug for $110M upfront

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Ultragenyx to cut about 20% of staff and discontinue Wilson disease gene therapy

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Boehringer Ingelheim and Sino announce potential $7B-plus cancer-drug deal

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T-Therapeutics raises $133 million to advance cancer and autoimmune therapies

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Evident Vascular wins FDA clearance for AI-enabled IVUS platform

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Tecvayli moves toward first-relapse use, with uptake shaped by logistics

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Debate grows over HHS policy allowing limited compounding of six unapproved peptides

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