Month: May 2018

BioMarin’s Palynziq (pegvaliase-pqpz) Receives FDA Approval for Phenylketonuria (PKU) in

Shots: The approval is based on P-III PRISM-2 study results assessing Palynziq (pegvaliase-pqpz, 20mg qd or 40mg qd) in patients in ratio (2:1) with high level of phenylalanine (Phe) The P-III PRISM-2 study resulted in maintaining blood Phe level vs PBO in patients Palynziq (pegvaliase-pqpz, SC) is an enzyme substitution therapy of phenylalanine hydroxylase (PAH) […]Read More

Pfizer’s Retacrit (epoetin alfa-epbx, biosimilar) Receives FDA Approval for Anemia

Shots: The approval is based on non-inferiority data demonstrating biosimilarity between Retacrit and the reference product, Epogen & Procrit In May, 2016 Pfizer and Vifor Pharma collaborated for the commercialization of retacrit in certain therapeutic areas Retacrit (epoetin alfa) a biosimilar to Epogen & Procrit, is an erythropoiesis-stimulating agent (ESA) indicated for anemia and reduction […]Read More