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Novel antibody therapeutic demonstrates potential in GVHD
Key data from a Phase II trial of a potentially first-in-class CSF-1R monoclonal antibody for chronic graft-versus-host disease (GVHD) has been released.
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EMA revises guidance on nitrosamine impurities
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
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Roche to co-develop hypertension RNAi therapeutic
An RNAi therapeutic that has best-in-disease potential for hypertension is set to be developed under a partnership between Roche and Alnylam Pharmaceuticals.
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EMA seeks public opinion on AI in drug development
Public consultation is open for the European Medicines Agency (EMA)’s draft reflection paper on using artificial intelligence (AI) when developing and regulating medicines.
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Genentech to reveal new data for ocular biologic
Data shared at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting will reveal new clinical and real-world evidence for the first bispecific antibody (bsAb) approved for the eye.
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The evolution of AAVs in cell and gene therapy
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
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Efficacy of novel drug proven in MDD study
Significant results from a Phase II study in major depressive disorder (MDD) for a novel kappa opioid receptor (KOR) antagonist has prompted initiation of a Phase III programme.
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New data suggests novel mAb could delay progression of early Alzheimer’s
Full results from the “first Phase III study of a disease-modifying therapy to replicate the positive clinical results observed in a previous study” have been published in JAMA.
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Ten-minute subcutaneous injection shows promise for MS
A Phase III trial for the only therapy approved for both relapsing and primary progressive multiple sclerosis (MS) met its clinical endpoints, Genentech has announced.
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WHO prequalifies meningitis conjugate vaccine
Prequalification by the World Health Organization (WHO) for the first conjugate vaccine to prevent meningitis caused by meningococcal group X could help “finally end all meningococcal meningitis epidemics in Africa”.
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Safety analysis published for C. diff biotherapeutic
The largest safety evaluation of any microbiota-based live biotherapeutic includes data for up to two years for the first approved microbiome-based treatment for recurrent Clostridioides difficile (C. diff).
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Post-approval R&D key in advancing oncology treatments
The Pharmaceutical Research and Manufacturers of America (PhRMA) has highlighted in a new report five R&D mechanisms that could facilitate full clinical value of oncology treatments after initial approval from the US Food and Drug Administration (FDA).
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Bispecific antibody approved in Europe for DLBCL
European approval of the bispecific antibody treatment has the potential to change the current standard of care in diffuse large B-cell lymphoma (DLBCL).
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Could faecal transplants improve melanoma immunotherapy?
In the first clinical trial of its kind, faecal microbiota transplants (FMT) were shown to improve immunotherapy response in advanced melanoma.
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Clinical research organisation market anticipated to reach $140bn by 2033
According to a report, growing demand for cost-effective and efficient drug development processes is propelling the global clinical research organisation (CRO) market.
