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Long COVID study expanded across Europe
If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.
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Vertex scores European cystic fibrosis medicine approval
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.
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New Amgen immunotherapy could treat common solid tumour
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.
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Digitalisation and PAT: current landscape and future trends
In this exclusive interview from CPHI 2023, Mohamed Noor, Digitalization Manager at the National Institute for Bioprocessing Research and Training (NIBRT), explores the trends, challenges and opportunities that digitalisation and process analytical technology (PAT) have within the biopharmaceutical industry.
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Fully instrumented 3D printed small-scale bioreactor developed
To support upstream bioprocess development, a study has demonstrated real-time monitoring of the growth phase in a 3D printed, single-use bioreactor.
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Trial for novel CGRP migraine medicine gleans positive results
The first pill designed to directly block calcitonin gene-related peptide (CGRP), a protein released during a migraine attack, has demonstrated positive evidence in AbbVie’s trial investigating its efficacy in the prodrome phase.
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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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FDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
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Approval-first for meningococcal vaccine
The first single vaccine to immunise against the five most common meningococcal disease serogroups in adolescents has been approved in the US.
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ESMO 2023: Janssen reveals data for intravesical delivery system
Phase IIb study results show evidence of sustained, durable complete responses beyond one year with an intravesical gemcitabine delivery system for a high-risk bladder cancer.
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Could Eli Lilly deliver first-line atopic dermatitis treatment?
Strong evidence of long-term efficacy of the IL-13 inhibitor lebrikizumab for atopic dermatitis has been demonstrated in Eli Lilly’s two-year extension trial.
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Sanofi treatment could slow type 1 diabetes progression
New Sanofi Phase III trial data adds to evidence of the treatment potential for the first disease modifying therapy in type 1 diabetes.
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Follicular lymphoma BTK inhibitor recommended by CHMP
Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
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Study reports rapid method for microbial contaminant detection
Research using fluorescent optical respirometry (FOR) illustrated successful detection of aerobic bacteria three hours after setting samples.
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ECNP 2023: new esketamine NS safety data for depression
New safety data for a Phase IIIb study in treatment-resistant depression (TRD), revealed at ECNC 2023, showed that esketamine NS significantly increased the proportion of patients achieving remission compared to quetiapine XR.
