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Biogen on aducanumab: ‘We’re ready for an immediate launch’ Biogen expects to begin shipping Aduhelm (aducanumab-avwa) in two weeks: after the FDA granted the Alzheimer's drug accelerated approval on Monday. There are around 900 sites across the US ready to implement treatment, including clinical trial centers and others with the necessary infrastructure to diagnose and treat patients. Initial supply will come from Biogen’s Research Triangle Park (RTP) in North Carolina: but Biogen eyes up global potential for the drug with its Solothurn, Switzerland faci...

Raw materials play a vital role in the development of cell and gene (CGT) therapies.

What are some of dos and don’ts on starter materials for CGT manufacturing? Raw materials play a vital role in the development of cell and gene (CGT) therapies. Mike Brewer, director, global principal consultant, regulatory, bioproduction, Thermo Fisher Scientific, spoke to BioPharma-Reporter about some of dos and don’ts on starter materials for CGT manufacturing. His advice is particularly targeted at newer entrants to the CGT space, those at the at the preclinical stage, that might not have the same level of regulatory expertise that more established players...

Samsung Biologics will add mRNA vaccine drug substance production capability to its facility in South Korea, aiming to provide end-to-end mRNA vaccine manufacturing services.

Sanofi and GSK have started the Phase 3 study for their COVID-19 vaccine candidate: eying up potential regulatory authorization in Q4, 2021.