Look back at pharma news in the week to November 1

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Last week’s news was dominated by a flood of third-quarter financial results, but there was still plenty of other events. On the regulatory front, Novartis’ already marketed gene therapy Zolgensma suffered a setback with a clinical hold from the US Food and Drug Administration on a new early-stage trial. Switzerland-based Roivant and Japan’s Sumitomo Dainippon Pharma confirmed their $3 billion alliance, with the surprise announcement of another “Vant” – Spirovant – being established. US biotech Dicerna Pharmaceuticals inked yet another lucrative licensing deal, this time with Roche on hepatitis B. Also, China’s BeiGene entered a deal with Amgen to market some of the latter’s products in China, which included a 20.5% equity investment in BeiGene for $2.7 billion.

Novartis gene therapy ambitions dealt another blow by FDA hold on Zolgensma

The Food and Drug Administration partially suspended a trial of Zolgensma in older children with spinal muscular atrophy because of an inflammatory response observed in a small animal study. The hold affects only a high-dose group in the STRONG trial, which delivers the gene therapy through a spinal injection known as "intrathecal" infusion, explained Jonathan Gardner on BioPharma Dive.

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