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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.
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Moderna reveals optimistic data for influenza-COVID-19 vaccine
Strong influenza and COVID-19 immunogenicity compared to approved standalone vaccines has been demonstrated in Moderna’s combination vaccine, interim Phase I/II trial data shows.
webinar
Accelerate shop floor productivity in pharma with paperless manufacturing
3 October 2023 | By Caliber
Watch this webinar to discover the power of paperless manufacturing and explore how this digital transformation can revolutionise your pharma manufacturing operations.
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AI-supported spectroscopy delivers superior pharmaceutical packaging QC
A combination of mid-infrared spectroscopy and artificial intelligence (AI) achieved excellent prediction capability for inline pharmaceutical packaging content verification, a study has shown.
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Achieving pharmaceutical drug traceability compliance
A paper has highlighted a technology system for achieving drug traceability compliance and help prevent production of counterfeit drugs.
