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WHO guidance aims to strengthen clinical trial ecosystem
The new recommendations are applicable to clinical trials in countries of all income levels and seek to make trials more effective and supportive for a diverse range of participants.
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Industry Insight
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PharmaLab Congress 2024 – what’s new for the third year in Düsseldorf/Neuss
Find out what is on offer for pharma professionals working in analytical development and microbiology QC at the 12th PharmaLab Congress being held in Germany in 2024.
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Microbial contamination detection with rapid spectroscopy
The detection method was designed for continuous culture monitoring of cell therapy products and required minimal sample preparation, research showed.
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Pharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
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Sepsis: addressing unmet needs for a global priority
Limited funding and a lack of drugs targeting the root cause of sepsis are some of the current obstacles when addressing the disease burden, GlobalData says.
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Lilly $1.8 billion investment to bolster Irish manufacturing
The expansion is planned to support production of Eli Lilly and Company’s medicines for diabetes, obesity and Alzheimer's and both sites will harness advanced technology and sustainability capabilities.
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Enzyme replacement therapy: improving outcomes in rare disease
In this article, Dr Alaa Hamed, Global Head of Medical Affairs for Rare Disease at Sanofi, shares why the company’s enzyme replacement therapy Xenpozyme® (olipudase alfa) has promise for the rare genetic disease acid sphingomyelinase deficiency (ASMD).
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Innovative medicine production site inaugurated in France
Sanofi’s novel manufacturing unit in France shortens production timelines and enables rapid changes in production capacities for medicines such as biologics and vaccines.
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GSK ultra-long-acting biologic shows Phase III potential
The treatment, being evaluated for severe asthma, is the first ultra-long-acting biologic to be evaluated in Phase III trials.
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Driving economic growth in UK with commercial clinical trials
The research “clearly demonstrates the financial and societal benefits that industry clinical trials bring to the economy, the NHS and to R&D in the UK”, APBI Chief Executive says about the report.
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Gene therapy trial facilitates major vision improvement
Some of the rare disease participants experienced fast and sustained improvement in their eyesight during the clinical trial, data shows.
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First-in-class combination therapy authorised for endometriosis
The three-in-one oral daily tablet provides an additional treatment option to help women in the UK manage their endometriosis-associated pain.
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Advancing NOX inhibitors for treating fibrotic diseases and cancer
This article explores the benefit of NOX inhibitors for fibrotic diseases and cancers and highlights the potential of Calliditas Therapeutics’ drug setanaxib, including its application in wider related indications.
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New WHO guidance to support manufacturers to reduce AMR risk
The recommendations offered in the guidance is applicable across different areas of manufacturing, from active pharmaceutical ingredients (APIs), through to formulation and packaging.
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Improving upstream fermentation with end-to-end automation
The automated system “significantly improved process control”, resulting in greater productivity of a small-molecule drug substance.
