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New Bill could enhance UK clinical trial regulation
According to a report on policy development in the UK, the Future Clinical Trials Bill will mandate transparent trial registration and facilitate quicker regulatory approval.
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Biopharma
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UK Clinical Trial Application submitted for amyloid-targeting drug
The Clinical Trial Application sent to the MHRA is for a combination drug with the potential to become a cost-effective treatment against early Alzheimer’s disease.
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NICE recommends first Parkinson’s treatment
A new, easy-to-use treatment option for advanced Parkinson’s could benefit around 900 adult patients on the NHS, according to National Institute for Health and Care Excellence (NICE) final draft guidance.
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Antibody-drug conjugates: paving the future of oncology clinical development
Dr Mark Rutstein, Senior Vice President, Head of Oncology Clinical Development at Daiichi Sankyo, highlights key data about the company’s antibody-drug conjugate (ADC) being investigated for breast and lung cancer, and shares insight into why ADCs could replace current standards of care in oncology.
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SGS ISL marks two-year anniversary
We are thrilled to celebrate two years since International Services Laboratory (ISL) in Ringaskiddy, Cork, Ireland, became part of the SGS network.
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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).
whitepaper
ebook: Enhancing impurity control with data management
Pharmaceutical quality standards are on the rise, putting pressure on development teams. See how Novartis is using Luminata to manage impurities data.
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Guidance on machine learning-enabled medical devices published
The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have issued guidelines to reduce the regulatory burden for machine learning-enabled medical devices.
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CPHI selects 2023 Pharma Award winners
Progress, innovation and sustainability across the pharmaceutical supply chain were recognised at the 2023 CPHI Pharma Awards.
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Europe’s pharmaceutical packaging market to value over $35bn by 2028
With the pharmaceutical industry placing greater emphasis on sustainability, as a material, paper will play a key role in Europe’s packaging and labelling market between 2023-2028, research predicts.
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siRNA drug delivery across the blood-brain barrier in Alzheimer’s
Carrie Taylor, Director of Research & Development at BOC Sciences examines the key pathologies in Alzheimer’s and highlights several promising siRNA drug delivery systems that offer potential in helping to overcome the neurodegenerative disease.
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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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How to approach die plate adhesion during tableting
A study by IMA and Labomar has illustrated a gentle but effective approach for achieving defect-free tablets and an adhesion-free die plate.
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Roche to gain rights to novel antibody for IBD
Roche is set to gain rights to develop, manufacture and commercialise a novel antibody treatment with first-in-class and best-in-disease potential for inflammatory bowel disease (IBD), under a new acquisition agreement.
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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.
