FDA Leader: We Need To Remove Surprises From Gene Therapy Development
Embattled gene therapy companies will take comfort from desire of FDA and EMA help smooth the process of bringing the novel treatments to market.
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Hopes rise as first four evaluable patients experienced no serious adverse events, and a sustained decline in level of key Huntington’s disease protein with the novel gene therapy product.
The UK company did not profit greatly from its role in COVID-19 vaccine, Vaxzevria, but hopes the same technology can form part of a breakthrough in hepatitis B.
Novartis is once again looking to be a pioneer in cell and gene therapy, though this time is selecting a potentially less complex administration method.