Santhera Receives Rare Pediatric Disease Designation from FDA
News Aug 25, 2015
Santhera Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for Santhera's lead orphan drug candidate, idebenone, for the treatment of Duchenne Muscular Dystrophy (DMD). The rare pediatric disease designation supplements the orphan drug designation granted by the FDA for idebenone to treat DMD in February 2007.
"We are pleased that the FDA has granted our request to designate idebenone for the treatment of DMD as a drug for a rare pediatric disease," said Thomas Meier, PhD, Chief Executive Officer of Santhera. "We already have Fast Track designation for idebenone in DMD and, on this basis, will be requesting priority review when we file the planned NDA. The potential to obtain a Rare Pediatric Disease Priority Review Voucher from the FDA, which we could retain for a future clinical development program of our own or sell, could provide additional value for the company in the future."
Elpis BioMed Closes Funding Round to Commercialise Novel Technology Platform for Generating Human Cell TypesNews
New Cambridge spin-out company commercialises disruptive technology that enables rapid generation of pure and consistent batches of human cell types. Geographically diversified, top-tier investor team includes key industry leaders to support early company development.READ MORE
Quotient Sciences Acquires Pharmaterials, a UK-based Contract Development and Manufacturing OrganizationNews
Quotient Sciences, the drug development services organization, announces it has acquired Pharmaterials, a contract development and manufacturing organization (CDMO) based in Reading, U.K..READ MORE
BOC Sciences Continues to Enlarge Its Publication Collection Using BOC Sciences ProductsNews
BOC Sciences continues to add more publication items that used BOC Sciences products in their researches to its already existing collection.READ MORE