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Accelerating drug development
Here, Dave Elder explores how a ‘quick-approval, quick-withdrawal from the market’ approach is used to accelerate drug development.
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AstraZeneca BTK inhibitor tablet approved in EU for leukaemia
The tablet formulation for AstraZeneca’s BTK inhibitor has gained EU approval for co-administration with gastric acid-reducing agents in chronic lymphocytic leukaemia patients.
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Identifying bacterial isolates to help prevent cleanroom contamination
A paper aiming to identify bacterial isolates on cleanroom operators’ garments, showed these surfaces were a major source of contamination.
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FDA approves first treatment for geographic atrophy
The first-ever treatment for geographic atrophy has been approved by the US Food and Drug Administration (FDA).
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EC approves first gene therapy for haemophilia B
The first gene therapy for haemophilia B has been given conditional marketing authorisation in Europe by the European Commission.
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European Pharmaceutical Review Issue 1 2023
EPR Issue 1 includes articles on the future of pharmaceutical microbiology, separation and purification of complex biologics, the latest on nitrosamines and more...
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Medicinal cannabis: the route to good manufacturing practice registration
Following on from the first GMP registration of a cannabis API for a UK pharmaceutical facility, EPR spoke with Celadon Pharmaceuticals about how it navigated the complex regulatory landscape.
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2022 UK life sciences recruitment report revealed
A report on the UK's 2022 Life Sciences recruitment market revealed laboratory was the busiest scientific function among in-demand roles.
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Enzyme replacement therapy for alpha-mannosidosis gets FDA approval
The first and only enzyme replacement therapy approved for alpha-mannosidosis in the US has been cleared for adult and paediatric patients.
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Fusion to acquire radiologand therapy for prostate cancer
An investigational new drug application for an ongoing Phase II trial of an alpha-emitting radiopharmaceutical will be acquired by Fusion Pharmaceuticals.
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Lonza completes bioconjugation facility expansion
The planned expansion of Lonza’s bioconjugation facility in Visp, Switzerland has been completed, the company has announced.
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European Commission awards €7.7 million to mechanochemistry project
€7.7 million has been awarded to IMPACTIVE by the European Commission to study mechanochemistry as a sustainable method for synthesising active pharmaceutical ingredients (APIs).
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Genentech to open new high-tech biologics facility
A new, high-tech, sustainable biologics manufacturing facility at Genentech’s US Oceanside campus will be operational in early 2025.
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Neoadjuvant nivolumab improves long-term survival for lung cancer
Analysis of a Phase II trial for non-small cell lung cancer has suggested neoadjuvant nivolumab improved five-year recurrence-free survival compared with historical outcomes.
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Johnson & Johnson appoints new Executive Vice President, Pharmaceuticals, R&D
An executive from Sanofi has been appointed as Johnson & Johnson’s new Executive Vice President of Pharmaceuticals, R&D.
