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Are we set for the revised EU GMP Annex 1?
23 August 2024 | By
This blog is a summary of the key changes of relevance to primary packaging components
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Drug Development
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Harnessing the GLP-1R medicine wave
As a promising treatment for type 2 diabetes and obesity, based on key trial data, the market for glucagon-like peptide-1 receptor (GLP-1R) therapies looks set to generate major sales up to 2030.
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First-of-a-kind trial holds promise for obesity and pre-diabetes treatment
The treatment reduces the risk of progression to type 2 diabetes and supports long-term maintenance of weight loss in adults with pre-diabetes and obesity or who are overweight, data indicates.
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Targeted therapies for chronic lymphocytic leukaemia in an evolving treatment landscape
Dr Mehrdad Mobasher, Chief Medical Officer for Hematology, BeiGene, discusses the evolution of therapies for chronic lymphocytic leukaemia (CLL), the promise of targeted treatments and what could be on the horizon of the therapeutic landscape for this disease.
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Innovative vaccine demonstrates sustained malaria immunisation in pregnancy
Follow up research to the presented findings could provide improved opportunities for preventing malaria in women during pregnancy.
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First-in-class therapy approved for chronic skin disease
The biologic treatment targets a key driver of prurigo nodularis, with trial data demonstrating improved itch as well as skin nodules for patients with the condition.
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Sustainable QC method for antimicrobial quantification
The new, cost-effective fluorimetric approach could help to mitigate clinical demand for the treatment of multidrug-resistant (MDR) bacterial infections.
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MSD set to acquire novel antibody for B-cell malignancies
The next-generation B-cell depletion biologic therapy has demonstrated promise in B-cell malignancies and autoimmune diseases.
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HDFN drug trial shows capability for alloimmune diseases
Based on the new data, nipocalimab could change the standard of care for treating the rare blood disease haemolytic disease of the foetus and newborn (HDFN).
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Regulating therapies for rare diseases – recent approvals
This article summarises some of the recent notable drug approvals in the EU and US, including a gene therapy and an enzyme replacement therapy.
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Personalised mRNA cancer therapy shown to boost immune response
The individualised neoantigen therapy could enable a precise, durable immune response, based on study findings in melanoma and lung cancers.
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Genentech-Sangamo deal to advance neurodegenerative treatments
Overall, Sangamo Therapeutics will be eligible up to $1.9 billion from Genentech, which includes various milestone and royalty payments.
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Downstream process shows potential for oncolytic virus purification
The paper presents an “efficient and scalable GMP-compliant process” for purifying a fusogenic oncolytic virus (rVSV-NDV).
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Science of scale for spray-dried intermediates
5 August 2024 | By
Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up – or scale-down – can play a key part in that process.
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FDA approves innovative engineered cell therapy
The accelerated approval by the US Food and Drug Administration (FDA) authorises the first engineered cell therapy for a solid tumour in the US.
