LEO Pharma A/S
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Latest From LEO Pharma A/S
For Cell And Gene Therapies, Expedited Designation And Complex Questions Improve FDA Meeting Chances
Designation as a regenerative medicine advanced therapy or breakthrough therapy ‘dramatically increases’ the likelihood of getting a meeting with the agency, Office of Tissues and Advanced Therapies’ Wilson Bryan says; more complex and innovative products, and more challenging questions, also are likely to win sponsors an audience with the FDA.
Standardizing the process for providing clarifications following sponsor meetings, particularly with regard to the written response-only format, is one of several solutions being piloted by the Office of Tissues and Advanced Therapies as part of its ‘growth program,’ which aims to expedite advances in cell/gene therapies while also improving staff satisfaction.
AbbVie inks collaboration and option deal focused on targeted protein degradation with Plexium. Cend and Calabrius merge in an all-stock transaction.
The upcoming review of two novel gene therapies from bluebird bio marks will be the first time the US FDA’s CTGTAC has met for a genetic product review in five years. That is a surprisingly long gap – and one that probably will not be repeated.
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