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Immunotherapy 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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Revised ISO guideline highlights toxicological evaluation of extractables and leachables
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
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Eosinophilic esophagitis medicine approval expanded
Approval of the first treatment for patients one year old and over with eosinophilic esophagitis (EoE) was based on trial data showing a greater proportion of children given Dupixent achieved histological remission compared to placebo.
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Key vaccine adjuvant biosynthesised
UK scientists have unlocked the potential of bioengineering vaccine adjuvants, based on a study of the molecule QS-21.
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Eli Lilly EVP of Global Quality to retire
Following her leading contribution in key manufacturing and quality projects in Ireland and the US, Eli Lilly and Company’s Executive Vice President (EVP) of Global Quality is set to retire after nearly 35 years of service.
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FDA guidance highlights E&L considerations for ophthalmic drug products
In draft guidance on quality considerations for topical ophthalmic drug products, the US Food and Drug Administration (FDA) provided recommendations for E&L testing.
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First-of-a-kind psoriasis study outcomes revealed
Phase III data for Janssen’s innovative IL-23 inhibitor has revealed that the biologic is effective for adults with moderate to severe plaque psoriasis (PsO) across all skin tones.
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Sanofi bets $1.7b on potential best-in-class rare disease therapy
Under its newly agreed acquisition, Sanofi is to acquire Inhibrx, Inc., adding INBRX-101 to its portfolio, a therapy that could improve the treatment options available for alpha-1 antitrypsin deficiency (AATD).
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Pharma 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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Will new therapeutic agent replace antibodies for bacterial detection?
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
webinar
Applying ISO/TR 14644-21 – Airborne particle sampling techniques
23 January 2024 | By Particle Measuring Systems
Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.
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Single-use systems to drive E&L testing market growth
The rising demand for biopharmaceuticals and a greater focus on cross-contamination are two of the biggest factors expected to impact the extractable and leachable (E&L) testing services market between 2023 and 2030, research predicts.
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NICE recommends innovative breast cancer drug
The first BRCA-targeted treatment has been recommended for advanced breast or metastatic breast cancer by the National Institute for Health and Care Excellence (NICE).
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Could novel antibiotic successfully treat a ‘priority 1 pathogen’?
Highlighting the potential of a novel antibiotic against acinetobacter infections, GlobalData explained that nine other drugs, alongside this promising treatment, are in clinical development for this indication.
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UK ATMP sector “robust”, research finds
The cell and gene therapy (CGT) sector in the UK is “robust”, with a stable clinical trials landscape, according to research from Cell and Gene Therapy Catapult (CGT Catapult) and the UK BioIndustry Association (BIA).
