news
Novel NMR-based method could facilitate safer API manufacturing
The innovative approach for detecting nitrosamine impurities in APIs addresses limitations of traditional mass-based techniques, research says.
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Drug Safety
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European Commission calls for bio-based innovation in new EU Bioeconomy Strategy
Changes proposed in the EU body’s regulatory framework aim to create a competitive and sustainable European bioeconomy.
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Dupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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Insmed wins first EU approval for non-cystic fibrosis bronchiectasis treatment
Oral small molecule treatment Brinsupri (brensocatib) could become a new standard of care for patients with the progressive lung disease.
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Internationally-compliant framework backs rabbit pyrogen test alternative
The approach aims to support broader FDA acceptance of the monocyte activation test (MAT) as a replacement, animal-free pyrogen test.
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MHRA approves Leqembi IV maintenance as additional Alzheimer’s option
Decision provides UK Alzheimer’s patients with an alternative administration method for Eisai and Biogen’s antibody drug.
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MHRA selects Prof Jacob George as its first Chief Medical and Scientific Officer
The cardiovascular expert will head the UK medicines regulator’s science and innovation strategies.
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MHRA set to overhaul the UK’s rare disease drug regulatory pathway
The medicines regulator will aim to take a more flexible licensing approach for the research and manufacture of rare disease therapies in the UK.
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Taiwan talks evidence-driven TCM at CPHI Frankfurt
Scientific and commercial opportunity for pharma companies looking to source, co develop and manufacture traditional Chinese medicine (TCM).
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Alexion wins EU label expansion for kinase inhibitor Koselugo
Approval provides continuity of care into adulthood for patients with neurofibromatosis type 1 (NF1) using Koselugo (selumetinib) to manage symptoms.
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Lilly’s baricitinib exhibits paediatric potential in major alopecia areata study
Results from the phase III study signify a successful collaboration with biopharma firm Incyte.
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Phase III data for next-gen green inhaler push GSK closer to Net Zero targets
New findings support use of salbutamol MDI formulation in the next-generation low carbon propellant as a more sustainable option for patients with respiratory disease.
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J&J’s Tremfya secures two paediatric psoriasis approvals from FDA
The US FDA approvals make the drug the first IL-23 inhibitor to be licensed for two common skin conditions.
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Navigating evolving clinical and regulatory expectations as mRNA outgrows its vaccine roots
Jianbo Diao, PhD, Director of Bioanalytical Services, WuXi AppTec, discusses the importance for mRNA therapy developers of adopting precise and flexible analytical strategies for future pipeline success.
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Lilly wins European Alzheimer’s approval for Kisunla after regulatory setbacks
The anti-amyloid monoclonal antibody is part of the class of medicines representing the first disease-modifying therapies for the neurodegenerative disease.
