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Synageva BioPharma SBC-102 Gets FDA ODD

SBC-102 is a protein designed to be identical to the enzyme that is missing. It is being evaluated in preclinical studies as a potential enzyme replacement therapy, or

Winston Pharma Submits NDA For Civanex

Winston Pharma’s application is expected to be subject to a standard review with a Prescription Drug User Fee Act (PDUFA) date in the second half of 2011. Winston

AVI BioPharma Opens AVI-4658 IND Application

AVI-4658 is an RNA-based therapeutic employing AVI’s new phosphorodiamidate morpholino oligomer (PMO) based chemistry and exon skipping technologies. It is being developed as a systemic treatment for patients

EMA Validates Ecallantide MAA: Dyax

DX-88 (ecallantide) has been approved by the FDA and is marketed as Kalbitor (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years