All articles by CE – Page 42
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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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NewsCHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
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NewsRevised 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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NewsMedicines for Europe calls for simpler SPC manufacturing waiver
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
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NewsEosinophilic 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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NewsKey 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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NewsEli 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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NewsFDA 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In draft guidance on quality considerations for topical ophthalmic drug products, the US Food and Drug Administration (FDA) provided recommendations for E&L testing.
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NewsFirst-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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NewsSanofi 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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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.
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NewsSingle-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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NewsNICE 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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NewsCould 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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NewsUK 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).
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NewsLong-term findings from CAR NK cell therapy trial revealed
One-year results from a cancer therapy trial has reported key findings for the selection criteria for allogeneic cord blood donors in CAR NK cell manufacturing.
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ArticleMarket outlook to 2032: future trends across the seven major markets
Challenges such as market exclusivity and patient treatment preference are expected to shape the insomnia and Gaucher disease therapy landscape in the seven major markets (7MM) in 2032, research predicts.
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NewsNovel heart failure drug could halt disease progression
Heart failure drug acoramidis could increase survival rates in transthyretin amyloid cardiomyopathy (ATTR-CM), Phase III study data suggests.
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NewsCould plastic alternative support environmentally-sustainable drug delivery?
Research highlighting recent advancements of the natural polymer tara gum point to its potential applications in pharmaceutical drug delivery, emphasising its role in minimising plastic use.