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Latest From FKD Therapies Oy
Argenx partners with Elektrofi and Iontas; China’s Qilu obtains global rights to Peptron’s antibody-drug conjugate and also ends co-development pact with Quantum Genomics.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
The Swiss group has decided to launch FerGene with the private equity giant to give the gene therapy nadofaragene firadenovec, which has a priority review at the FDA, a better chance for a successful launch in the US.
UroGen's reverse thermal gel formulation of mitomycin produced a high rate of complete responses in patients with urothelial cancer; developing a commercialization strategy for the product will benefit from the experience of the company's new CEO.
- Gene Therapy, Cell Therapy