WuXi Biologics will make components of COVID-19 vaccines and other biologic products at the facility it bought from Bayer. The Chinese CDMO acquired the plant in Wuppertal, Germany last month in a deal valued at around €150 million ($185 million). Bayer had originally planned to use the Wuppertal plant to produce recombinant factor VIII products. However, in November 2018 the firm announced it would not commission the facility. A Bayer spokesman told us “the decision was based on a review…
The US FDA has issued a complete response letter for Leqvio (inclisiran) due to ‘unresolved facility inspection-related conditions’ at a third-party site run by Corden Pharma. In October 2020, this publication reported the US approval of Novartis’ small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, Leqvio, was dependent on a regulatory inspection at a third-party manufacturer in Italy. While Novartis spoke of regulatory delays of up to five months caused by COVID-19, it…
Pfizer is focusing on building out an inventory of existing products to concentrate on vaccine production in 2021, the firm says. Pfizer and BioNTech’s mRNA-based COVID-19 vaccine was approved by the European Commission on 21 December, joining previous approvals in the US and the UK, as the partners prepare their commercial manufacturing capacity. Pfizer reduced estimates regarding the number of vaccines it would be able to produce in 2020 from 100 million to 50 million in November. For 2021, the…
The UK aims to grow its cell and gene therapy workforce with both a training network and by recruiting from outside the sector. According to Cell and Gene Therapy Catapult (CGTC)’s research, 83% of companies operating in the advanced therapy sector stated that a lack of skilled employees will be one of the main issues that slows down or causes a delay to their forecasted expansions. CGTC projects that the workforce in the industry will need to double from approximately…