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Catherine Eckford (European Pharmaceutical Review)
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
In this exclusive interview, Stephen Ward, Chief Manufacturing Officer and Jeanette Evans, Chief Business Officer, Cell and Gene Therapy Catapult, highlight key data from the organisation’s recent GMP Manufacturing Survey and Skills Demand reports, and present insight into the sector’s current and future landscape.
Following the acquisition from Viatris, Biocon Biologics and its partners state that they will commercialise biosimilar products in 31 European countries.
New data from a Phase III gene therapy trial has demonstrated a 90 percent three-year overall survival rate for its participants with a high-risk bladder cancer.
The new industry collaboration aims to help decarbonise the global supply chain by focusing on the energy-intensive pharmaceutical manufacturing that takes place in China and India.
Alexion’s intravenous enzyme replacement therapy has been recommended for the ultra-rare disease by the National Institute for Health and Care Excellence (NICE).
Using an investment of more than €2.1 billion, a planned expansion at one of Novo Nordisk’s strategic production sites will include additions such as aseptic production and the extension of its Quality Control Laboratory.
Following a milestone approval by the European Commission in July 2023, Vertex Pharmaceuticals has been granted a label expansion for its cystic fibrosis medicine KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) with ivacaftor.
With demonstrated benefit in anti-tumour activity and overall survival in patients with small cell lung cancer, Tarlatamab could provide a new third-line option, a Phase II study suggests.
Through a new acquisition, Boehringer Ingelheim will have rights to a platform that enables the design of immuno-oncology combination therapies in one single agent.