All Pharmacovigilance and safety oversight articles – Page 21
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NewsEC approves lebrikizumab for atopic dermatitis
Monoclonal antibody, lebrikizumab, is approved in Europe for treatment of adults and adolescents with moderate-to-severe atopic dermatitis.
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NewsTrial 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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NewsFirst 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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NewsCHMP recommends new immunotherapy delivery method
If approved, Roche’s Tecentriq subcutaneous (SC) would be the EU’s first injectable PD-(L)1 cancer immunotherapy.
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NewsNovel siRNA therapeutic could lower cardiovascular disease risk
A Phase II trial for the small interfering RNA (siRNA) therapeutic lepodisiran is currently underway, assessing its ability to reduce lipoprotein(a) levels.
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NewsFirst chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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NewsTargeted therapy for hard-to-treat leukaemia subtype approved in EU
A FLT3 inhibitor that has been shown to significantly improve FLT3-ITD positive acute myeloid leukaemia survival has been authorised in the EU.
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ArticleDeveloping a first-in-class small molecule drug for inflammatory disease
In this exclusive Q&A, Dr Jenna Brager, Executive Vice President of Drug Development for MyMD Pharmaceuticals® explains to EPR why its oral small molecule drug could transform how TNF-α based diseases are treated.
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NewsInnovative insomnia study aims to overcome major clinical trial bottleneck
A new UK trial investigating a standard insomnia treatment is a “significant step forward in patient-centric trial design”.
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NewsMHRA authorises new treatment for rare lung cancer
A “potential best-in-class treatment” for adults with KRASG12C-mutated non-small cell lung cancer (NSCLC) has been authorised in the UK.
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NewsAAO 2023: intravitreal treatment shows benefit in geographic atrophy
Results from Iveric Bio’s Phase III trial demonstrated that over a two-year period, IZERVAY™ (avacincaptad pegol intravitreal solution) reduced geographic atrophy (GA) lesion growth as early as six months.
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Whitepaper
Application note: Highly efficient method development for analysis of oligonucleotides
Thorough quality control of nucleic acid drugs is important to ensure their safety and efficacy. In this application, an automated computer-aided workflow was used for highly efficient method development.
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NewsGene therapy for rare muscular dystrophy presents preliminary promise
Initial clinical results for a gene therapy being evaluated in limb-girdle muscular dystrophy has shown evidence of transgene expression in the three-month muscle biopsy.
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NewsNew 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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NewsUK 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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ArticleAntibody-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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NewsFDA 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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ArticlesiRNA 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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NewsESMO 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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NewsCould 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.