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Rapid pseudomonas aeruginosa detection method developed
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
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Data Analysis
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J&J reveal long-term data for novel oral peptide
The new data suggests the IL-23 receptor antagonist peptide has potential to address the high unmet need of a durable and convenient oral option in moderate-to-severe plaque psoriasis.
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Data 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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Employing 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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Medical 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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Analytica 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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New 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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NICE 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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Implications 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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CHMP 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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Driving 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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UK 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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Single-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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New 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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Taming 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.
