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Amicus' Pompe disease therapy joins early access scheme pharmatimes
June 10, 2021
Patients with late-stage Pompe disease who are failing to respond to enzyme replacement therapy will now have early access to an alternative treatment option, after Amicus Therapeutics' cipaglucosidase alfa with miglustat was approved for the UK's ...
Amicus, Catalent Biologics Enter Gene Therapy Mfg. Pact contractpharma
July 03, 2019
Will support clinical and commercial supply needs for Pompe and other Lysosomal Disease Gene Therapy Programs.
WuXi Biologics Congratulates Amicus on Receiving FDA Breakthrough Therapy Designation for AT-GAA en-cphi.cn
March 01, 2019
The second product successfully receiving Breakthrough Therapy Designation that WuXi Biologics has enabled its partner to develop
WuXi Biologics and Amicus Sign Exclusive Manufacturing Partnership Wuxi Biologics
February 12, 2019
WuXi Biologics and Amicus Therapeutics announced that the companies have entered into an exclusive commercial manufacturing partnership for Amicus' Pompe biologic ATB200.
Biogen and Amicus win UK Prix Galien awards for rare disease medicines pharmaceutical
November 21, 2018
Medicinal products selected as the UK Prix Galien Award finalists were for orphan conditions. Credit: DraconianRain.
FDA approves Amicus' Galafold for Fabry disease biospectrumasia
August 14, 2018
The efficacy of Galafold was demonstrated in a six-month, placebo-controlled clinical trial in 45 adults with Fabry disease.
Amicus’ Galafold wins US approval pharmatimes
August 14, 2018
Amicus Therapeutics’ Galafold has been approved in the US as the first oral medication for the treatment of adults with Fabry disease.
Amicus to file Fabry drug after FDA changes mind pharmaphorum
July 13, 2017
Amicus Therapeutics is to file its oral Fabry disease medicine migalastat with the FDA after the regulator dropped a demand for further efficacy data.