Thursday, May 3, 2018 Daily Archives

eBook: The Commercial Expression Systems Market — What Has Changed in the Past Decade

A decade ago, BioPlan Associates prepared the findings of its 2008 directory of expression system technologies that were being promoted or considered likely to be suitable for commercial licensing for biopharmaceutical manufacturing (1). Due in part to the relatively slow advances in this critical area of bioprocessing, this study remains perhaps the only directory of biopharmaceutical-relevant expression systems available for licensing. Here I discuss aspects of related bioprocessing technologies that have and have not changed in the past decade. Expression…

Sandoz Receives CRL for Rituxan Biosimilar

Novartis’ Sandoz remains committed to further discussions with the US FDA after receiving a complete response letter (CRL) for its rituximab biosimilar candidate. The Biologics Licensing Application (BLA) for Sandoz’ proposed biosimilar of Roche’s autoimmune disease drug Rituxan (rituximab) suffered a setback yesterday when the US Food and Drug Administration issued a CRL. A Sandoz spokesperson told BioProcess Insider that the firm is “still evaluating the content†of the letter and specific details are not being divulged for now. “The…

Jazz Pays Spark $110m for Luxturna Priority Review Voucher

Spark Therapeutics has sold its Rare Pediatric Disease Priority Review Voucher (PRV) to Jazz Pharmaceuticals for US$110 Million (€92 million). Spark Therapeutics received the PRV from the US Food and Drug Administration (FDA) when its gene therapy for inherited retinal disease, Luxturna (voretigene neparvovec), was approved. But the firm disclosed in an SEC filing it is selling the voucher to Ireland-headquartered biopharma firm Jazz to help support its future R&D. “We will invest the proceeds from the sale back into the…