Tuesday, May 5, 2020 Daily Archives

Swiss site set to make Biogen Alzheimer’s MAb from 2021

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Biogen says construction of its manufacturing site in Switzerland is complete and will produce commercial supply of aducanumab if the potential Alzheimer’s blockbuster is approved. Biogen has had a turbulent time with its proposed Alzheimer’s disease monoclonal antibody aducanumab. In 2015, data was announced that led the company to outline a Phase III study. Then in March 2019, late-stage results prompted Biogen to shelve the drug. Months later, the firm resurrected the program, after “new analysis of a larger dataset 

May 5, 2020

UK Gov teams to aid academic gene therapy developers source vectors

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Academics developing gene therapies often struggle to source vectors say the MRC and Lifearc, which plan to set up UK viral vector production network. The Medical Research Council (MRC) – a non-departmental government agency – and Lifearc – a research charity – announced plans for the network and a £16 million ($20 million) fund for the project on May 4. The idea is to provide grants UK-based research organizations can use to expand vector suites or repurposed facilities to make…

May 5, 2020

Want to keep up with demand for CGT testing? Stay nimble and invest, says Eurofins

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With record numbers of cell and gene therapies in development, Eurofins BioPharma Product Testing is investing in specialized technologies and scientific talent to tackle technical and regulatory questions around biosafety, characterization, and functionality. The advanced therapy services space is booming, riding the wave of cell and gene therapies (CGTs) entering and progressing through the clinic. While only a handful of such products have reached commercialization, the US Food and Drug Administration (FDA) anticipates numerous approvals in the coming years based…

May 5, 2020