Author: Rosenmayr-Templeton, L.
Title: Industry news update covering May 2021 Cord-id: 8ot1lrgd Document date: 2021_1_1
ID: 8ot1lrgd
Snippet: This round-up of industry news covers May 2021. In many respects the most striking news came in the form of two FDA accelerated approvals for products targeted at specific mutations found in NSCLC and one EMA positive opinion for a gene therapy for a rare, progressive neurodegenerative disease in children. All three therapies offer hope to patients with previously very limited treatment options for significant improvements in prognosis and survival times. These therapies and their authorization
Document: This round-up of industry news covers May 2021. In many respects the most striking news came in the form of two FDA accelerated approvals for products targeted at specific mutations found in NSCLC and one EMA positive opinion for a gene therapy for a rare, progressive neurodegenerative disease in children. All three therapies offer hope to patients with previously very limited treatment options for significant improvements in prognosis and survival times. These therapies and their authorization underline how far drug discovery, development and regulatory science has progressed in exploiting the genetics underlying disease, biopharmaceutical manufacturing technology and new approaches to clinical development and regulatory review to bring products for unmet clinical needs rapidly to market.
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