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Deze mountainbiketocht is een initiatief van het Nederlandse Duchenne Parent Project en wordt georganiseerd in samenwerking met de Nederlandse stichting "Evenementen voor Maatschappelijke Organisaties Foundation (Emolife)".

dinsdag 21 september 2010

Food and Drug Administration (USA) stemt toe met verdere studie Ataluren

PTC THERAPEUTICS AWARDED $1.6 MILLION FDA ORPHAN DRUG GRANT TO SUPPORT AN ONGOING PHASE 3 STUDY IN CYSTIC FIBROSIS

SOUTH PLAINFIELD, NJ – SEPTEMBER 21, 2010 – PTC Therapeutics, Inc. (PTC) today announced a grant award of approximately $1.6 million from the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OPD) to support an ongoing Phase 3 study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF). The goal of the FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy.

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