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Pioneering malaria vaccine gains regulatory clearance
University of Oxford-developed R21/Matrix-M malaria vaccine has secured approval in two African countries.
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Drug Supply Chain
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Yescarta® demonstrates promising European manufacturing experience
In newly published analysis, Kite's CAR T-cell therapy delivered a reduced median European manufacturing turnaround time for diffuse large B-cell lymphoma (DLBCL) patients.
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Pharma within planetary boundaries
Regulatory changes along a drug’s lifecycle should ensure that the health benefits of pharmaceuticals, which have a large ecological footprint, do not cost the environment. Dorothea Baltruks, Research Associate at the Centre for Planetary Health Policy, outlines how forthcoming EU pharmaceutical legislation could pave the way to solutions.
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Biogen to develop amyloid beta-targeting antibody platform
The next-generation of anti- amyloid beta therapeutics could be advanced by Biogen exercising the option to develop Denali’s antibody programme.
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Generic manufacturers sign sublicences to produce long-acting HIV medicine
Sublicence agreements signed by the Medicines Patent Pool (MPP) and three generic manufacturers could enable millions to access a long-acting HIV medicine.
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£277m investment to advance UK life sciences manufacturing
Four UK life sciences companies are set to benefit from a £277m investment in the first tranche of Life Sciences Innovative Manufacturing Fund (LSIMF) grants.
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New biologics manufacturing facility gets $1b investment
Eli Lilly’s new biologics manufacturing facility in Ireland will utilise technologies such as automation and support sustainable practises.
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Rapid microbiology testing market growth expected 2022 to 2027
Driven partly by growth-based methods, the rapid microbiology testing market is predicted to expand considerably from 2022 to 2027, says a report.
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EMA publishes mid-point regulatory science strategy report
Progression in supporting development of precision medicine was noted as an achievement in a mid-term report on the EMA’s Regulatory Science Strategy to 2025.
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Takeda to build £600m plasma therapy manufacturing site
Takeda’s largest manufacturing capacity expansion investment in Japan will fund the build of a new facility for plasma-derived therapies.
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Parallel import of medicinal products: regulatory update
Andrzej Siwiec and Katarzyna Bajer of DBS Law discuss recent rulings on the parallel import of medicinal products in the European Union.
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Sandoz to build biologics plant in Slovenia
To support increasing biosimilar demand, Sandoz’s expected investment of $400m will fund construction of a new biologics plant in Slovenia.
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New NHS cell and gene therapy centre opens
The new Clinical Biotechnology Centre (CBC) in Bristol will manufacture cell and gene therapies to help boost the UK life sciences sector.
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Moderna chooses mRNA vaccine manufacturing centre location
Following finalisation a ten-year strategic partnership with the UK government, Moderna has chosen the location for its Innovation and Technology Centre (MITC).
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Pharma responds to UK government Statutory Scheme rise
The ABPI and Lilly have responded to the UK government’s confirmed plans to increase the payment percentage in the Statutory Scheme to control the costs of branded medicines.
