All Data Analysis articles – Page 4
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NewsOne-time gene therapy could “transform” Huntington’s treatment landscape
uniQure’s positive topline data “are the most convincing in the field to date” and indicate the gene therapy’s potential disease-modifying effects.
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NewsNovel analytical approach could aid quality control during nitrosamine analysis
The innovative approach facilitates QSRR-assisted chromatographic development for N-nitrosamine analysis in pharmaceutical products.
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NewsBayer claims cell and gene therapy first in Parkinson’s research
Advances cell therapy and gene therapy candidates, with both showing neurorestorative potential against the disease.
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NewsNovo Nordisk’s once-weekly diabetes jab Kyinsu set for European approval
EMA advisors at the CHMP backed the combination treatment and also recommended Bayer’s menopause drug Lynkuet, putting both on the path to being licensed.
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ArticleSimplified rAAV lysate purification for complex analytics of upstream samples
Bioprocess experts from Sartorius BIA Separations and BridgeBio Gene Therapy illustrate an approach with potential to expedite AAV upstream analytics and lower overall process development costs.
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ArticleMicrobiology/RMM In-Depth Focus 2025
This in-depth focus features articles on rapid microbiological methods, quality control, and using AI to read agar plates.
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ArticleEuropean Pharmaceutical Review Issue 3 2025
EPR Issue 3 includes articles on microbiology, downstream processing, manufacturing, drug formulation and more.
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NewsBiogen wins European first for depression drug Zurzuvae
The medicine becomes the first EU-approved oral treatment for adults who have postpartum depression (PPD).
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NewsFDA approves first-of-a-kind intravesical drug delivery system for bladder cancer
The innovation is set to change how eligible bladder cancer patients in the US are treated who are unresponsive to traditional therapy.
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FDA to modernise review process for developers of ultra-rare diseases
The regulator’s new principles aim to ease the pathway to regulatory approval for rare disease drug developers in the US.
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NewsRoche en route to first continuous delivery treatment for nAMD in Europe
CE mark for Contivue platform supports its ambitions for Susvimo in age-related macular degeneration (AMD).
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Teva wins US obesity approval for its GLP-1 generic liraglutide
And Eli Lilly and Company’s new oral GLP-1 obesity therapy orforglipron shines in late-phase clinical trials.
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Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart
The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.
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NewsSanofi’s Tzield type 1 diabetes immunotherapy wins UK first
Becomes the first monoclonal antibody for the condition to be approved by the MHRA and advances the pharma company’s ambitions in diabetes.
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NewsDaewoong's microneedle patch marks semaglutide first in obesity
Pharmacokinetic study of the novel drug delivery method shows high relative bioavailability in a once-weekly regimen.
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AI driving automated microbiological testing market growth to 2033
Regulatory pressures and demand for trained operators is expected to hinder growth of the rapid microbiological testing market into the next decade, research suggests.
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NewsNew AbbVie data highlights Rinvoq promise in alopecia areata
The trial is the first pivotal clinical programme to have met the standard of complete scalp hair regrowth, suggesting potential in immune-mediated diseases.
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Broad label FDA approval for phenylketonuria drug
Alongside Phase III data demonstrating significant efficacy in the rare disease, the FDA’s decision could position the small molecule as a future standard of care.
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NewsExtension trial demonstrates long-term benefit for Lilly Alzheimer's drug
The new findings support a limited duration dosing approach and highlight the consistent safety profile for Eli Lilly’s antibody drug.
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NewsConsiderations for contact plate recovery in cleanrooms
The study provides greater insight into some of the key factors that affect microbiological surface contamination in cleanrooms.