Friday, August 9, 2019 Daily Archives

FDA and NIIMBL partner to advanced biomanufacturing innovation

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The US FDA has expanded its partnership with NIIMBL to strengthen biomanufacturing through innovations such as 3D printing and continuous manufacturing. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) launched in March 2017 to accelerate innovation in biopharmaceutical manufacturing and support the development of standards to drive more efficient and rapid manufacturing capabilities. Institute Director, Kelvin Lee told Bioprocess Insider the institute is already working with the US Food and Drug Administration (FDA) in a variety of contexts –…

August 9, 2019

Pfizer licenses AAV platform for ataxia gene therapy

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Pfizer will use REGENXBIO’s adeno-associated virus (AAV) delivery platform for a gene therapy aimed at treating neurodegenerative disease Friedreich’s ataxia. In REGENXBIO’s second quarter 2019, a major milestone was reached with the approval of Novartis/Avexis’ Zolgensma (onasemnogene abeparvovec). The gene therapy uses the NAV Technology Platform, created and validated by REGENXBIO’s founders and collaborators at the University of Pennsylvania, which uses over 100 adeno-associated viral (AAV) vectors to deliver engineered genes to cells. The firm, which is also developing its…

August 9, 2019

Pro-biosimilar policies will not ignite US market, Amgen

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Amgen says the US needs a vibrant competitive biologics market but must avoid policies that tilt the playing field in favor of biosimilar makers. Biosimilars made an initial mark in the US when the Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim) in 2015. But in the proceeding four years, the sector has somewhat stalled – despite 22 more approvals – amid ongoing political debate, legal complexities and pricing/reimbursement. The idea of Congress addressing drug pricing and patent issues,…

August 9, 2019

GE and Millipore drive ‘exceptional’ quarter for Repligen’s Protein A

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Sales in its proteins business grew over 40% year-on-year as Repligen experienced higher than expected demand for Protein A ligands from customers MilliporeSigma and GE Healthcare. Bioprocessing vendor and protein supplier Repligen Corporation reported another record quarter with sales of $71 million (€63 million), up 48% year-on-year. The firm has spent the past few years diversifying its portfolio – and areas of investment in filtration and chromatography, for example, helped drive the quarter – but strong results came from its…

August 9, 2019