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THERANEXUS AND BEYOND BATTEN DISEASE FOUNDATION (BBDF) WIN US INVESTIGATIONAL NEW DRUG (IND) APPROVAL TO START CLINICAL DEVELOPMENT OF BBDF 101
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02 marzo 2021 17:14
Fonte: Adnkronos
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AUSTIN, Texas, March 2, 2021 /PRNewswire/ Beyond Batten Disease Foundation (BBDF) is pleased to announce an agreement with Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson, to provide Zavesca® (miglustat) for the development of BBDF-101, a proprietary combination of miglustat and trehalose to treat juvenile Batten disease (CLN3). Janssen will provide drug supply for the clinical trials and Extended Access Program, and right of reference to data within the Zavesca New Drug Application (NDA) to support the development of BBDF-101.
CLN3, one of a group of disorders known as neuronal ceroid lipofuscinoses (NCLs), is a rare, fatal, inherited, neurodegenerative disease for which there is no treatment. Since it was founded in 2008, BBDF has spearheaded the development of BBDF-101.
Beyond Batten Disease Foundation Announces Agreement with Actelion Pharmaceuticals Ltd to Provide Drug Product for BBDF-101
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