A new gene and cell therapy production facility in Maryland Precigen's new manufacturing facility has officially opened its doors in Germantown, Maryland. The wholly-owned subsidiary of Intrexon commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The good manufacturing practices (GMP) facility…..
Waylivra™ (volanesorsen), first therapy for familial chylomicronemia syndrome The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending conditional marketing authorization for Waylivra™ (volanesorsen) for the treatment of familial chylomicronemia syndrome (FCS). This antisense oligonucleotide developped by Ionis Pharmaceuticals and its affiliate Akcea…..
First European Market Approval for Nanobiotix The French nanomedicine company Nanobiotix has received its first European market approval (CE mark) enabling commercialisation of its lead product Hensify® (NBTXR3) in the 27 EU countries for the treatment of locally advanced soft tissue sarcoma. “We could not be more proud to receive market approval…..