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Trends and challenges in pharmaceutical development
EPR sat down with Catalent’s Stephen Tindal at CPHI Barcelona for a conversation on trends and challenges in pharmaceutical development.
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R&D
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Single-use bioprocessing market to value $84.14bn by 2032
In the single-use bioprocessing market, research states that automation offers benefits such as process control in biopharma manufacturing.
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First CRISPR-based gene-editing therapy authorised
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a world-first regulatory authorisation to a medicine based on Nobel Prize-winning technology.
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Advancing clinical development in haematology oncology
Newly appointed Vice President of Medical Affairs, Europe at BeiGene, Dr Jan-Henrik Terwey, provides exclusive insight on clinical development in the haematology/oncology space, and highlights significant data for its BCL-2 inhibitor, sonrotoclax.
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Chromatography technique developed as continuous on-line PAT tool
The widely used continuous chromatography technique, simulated moving bed (SMB) chromatography, developed to the micro-scale as a process analytical technology (PAT) application, has been shown to greatly increase mass spectrometry sensitivity.
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CHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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Sandoz mobilises critical medicine production in Europe
Alongside its new biosimilar facility, Sandoz’s new penicillin production process will help secure European-based antibiotic supply.
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New acquisition to support global gene therapy manufacturing
Acquisition of Forge Biologics by Ajinomoto Co., Inc. is set to extend global capabilities in AAV and plasmid gene therapy manufacturing for Ajinomoto, Co. Inc.
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Unified vision essential in UK advanced manufacturing
A new report outlines five critical actions for five of the UK’s leading manufacturing sectors to ensure sustainable innovation growth is achieved.
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Guide to Outsourcing 2023
In this Guide to Outsourcing, EPR explores trends in outsourcing of regulatory activities, Quotient Sciences discusses how to accelerate drug development and Associates of Cape Cod International looks at sustainable bacterial endotoxin testing.
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Could GSK myelofibrosis treatment gain EU-first approval?
If approved, momelotinib will be the first treatment in the EU indicated for myelofibrosis patients with moderate to severe anaemia.
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Novel siRNA therapeutic could lower cardiovascular disease risk
A Phase II trial for the small interfering RNA (siRNA) therapeutic lepodisiran is currently underway, assessing its ability to reduce lipoprotein(a) levels.
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First chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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Formulation In-Depth Focus 2023
This in-depth focus features articles on paediatric formulations as well as the role of definitive screening design in improving biopharmaceutical development.
whitepaper
Scientific journal: Complete your clinical research 6 to 9 weeks faster
Discover how completing your trials in Canada can accelerate your early phase clinical research by six to nine weeks compared to an IND submission.
