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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze