All Data Analysis articles – Page 18
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ArticleData integrity considerations in pharma and life sciences
In this Q&A, data expert Joseph S Boakai addresses decisive factors impacting data integrity in the pharma and life sciences industries.
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NewsEmploying MALDI-TOF MS for microbial identification in sterile drug manufacturing
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
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NewsMedical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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ArticleAnalytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum ...
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NewsNew data revealed for Novartis SMA gene therapy
Novartis has revealed new data for its one-time gene therapy for spinal muscular atrophy (SMA) in older children.
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NewsNICE recommends first licenced treatment for AL amyloidosis
Having been available in Scotland and Northern Ireland since 2022, NICE’s positive opinion of the combination treatment means it is now accessible on the NHS.
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NewsImplications of AI regulation for data integrity
According to research, organisations should invest in training for those working with artificial intelligence (AI) to support data integrity assurance in AI applications.
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NewsCHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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ArticleDriving the UK’s “innovation engine” for novel AMR therapeutics
Despite the UK having “a very healthy” therapeutic pipeline, more needs to be done in the fight against antimicrobial resistance (AMR), NovaBiotics’ CEO asserts.
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NewsUK manufacturing output expected to improve despite challenges
Output volumes for UK manufacturing fell in the three months to February 2024, yet it is expected to rise slightly in the next three months, research reports.
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NewsSingle-use technology propelling upstream bioprocessing market expansion
A driving factor behind the expansion of the upstream bioprocessing market is the need for process improvement in the biopharma industry, research highlights.
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NewsNew chemotherapy treatment could benefit multiple cancer types
The innovative treatment significantly increased survival in patients with malignant pleural mesothelioma, a rare, aggressive cancer, according to Phase III data from UK researchers.
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ArticleTaming cardiovascular risk: the promise of LDL cholesterol lowering therapeutics
In this exclusive interview, CEO of NewAmsterdam Pharma, Michael Davidson, offers insight into the low-density lipoprotein (LDL) cholesterol lowering therapeutic landscape and shares promising data from the company’s lead candidate, a cholesterol ester transfer protein (CETP) inhibitor.
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NewsPharmaceutical suspension market to witness accelerated growth
The global pharmaceutical suspensions market is set to value $83.8 billion by 2032, due to the systems having key benefits such as supporting patient compliance.
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NewsNext-in-class combination treatment shows potential in cystic fibrosis
Phase III trials have found CFTR modulator vanzacaftor/tezacaftor/deutivacaftor (vanza triple) to be non-inferior to TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in improving cystic fibrosis lung function.
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NewsBiosensing technique promising for whole-genome detection
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
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NewsImmunotherapy drug achieves trial-first in fifty years
Major findings from a Phase III trial show that using immunotherapy drug pembrolizumab post-surgery extended survival and delayed disease recurrence in kidney cancer.
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ReportPharma Horizons: Artificial Intelligence
EPR’s inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
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NewsWill new therapeutic agent replace antibodies for bacterial detection?
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
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NewsOptimised method could facilitate analysis of complex biologics
An effective analytical framework for a broad spectrum of monoclonal antibodies (mAbs) and complex mAb biotherapeutics has been developed, according to a recent study.