GSK and Amicus Therapeutics Revise Migalastat Agreement
GSK and Amicus Therapeutics revise Fabry agreement entered into in July 2012.
GlaxoSmithKline (GSK) and Amicus Therapeutics have revised their drug-development under which Amicus has obtained global rights to develop and commercialize the investigational pharmacological chaperone migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease.
Under the terms of the revised agreement:
- Amicus will have sole rights to the global drug development, regulatory and commercial activities for the next-generation Fabry ERT (migalastat HCl co-formulated with ERT) as well as migalastat HCl monotherapy
- GSK will be eligible for future regulatory and commercial milestone payments, as well as royalty payments.
- GSK will further invest $3 million in Amicus through an equity investment in a concurrent private placement in public equity (PIPE) transaction
Source: GlaxoSmithKline
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
