All articles by Catherine Eckford (European Pharmaceutical Review) – Page 22
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NewsFirst real-world study reveals encouraging efficacy for cell therapy
More than half of the multiple myeloma patients included in this study would have been ineligible for the Phase II CARTITUDE-1 clinical trial, research reports.
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NewsEnhancing intestinal drug delivery with Quality by Design
Research has highlighted a potential oral drug delivery approach using Quality by Design (QbD) principles to improve treatment of the colonic disease diverticulitis.
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NewsEuropean manufacturing facility to strengthen gene therapy supply
The new manufacturing facility in Finland will aid global supply of the first FDA-approved intravesical non-replicating gene therapy for adults with a common cancer.
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NewsGenentech gains rights to next-generation CDK inhibitors
The oncology-focused deal between Genentech and Regor Pharmaceuticals is worth nearly $900 million and will support development of novel therapies for breast cancer.
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NewsOptimising wet granulation manufacturing with advanced technologies
The approach proposed in the paper suggests how artificial intelligence (AI) and machine learning (ML) could enhance process efficiency and product quality during complex manufacturing.
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NewsRadiopharmaceutical therapy delivers promising meningioma survival rates
The Phase II clinical trial is the first completed prospective trial for refractory meningiomas with a tumour growth rate of 15 percent or more over six months.
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NewsFirst-in-class therapy approved for schizophrenia
The “landmark” approval represents the first new class of medicine in several decades for treating schizophrenia.
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NewsWHO 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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NewsMicrobial 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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NewsNew collaboration to boost access to innovative microbiome therapies
The new agreement, focused on improving regulation and drug development within the microbiome therapeutic sector, will harness cross-sector cooperation to ensure these medicines become available to more patients.
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NewsSepsis: 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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NewsLilly $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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ArticleEnzyme 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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NewsInnovative 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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NewsGSK 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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NewsDriving 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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NewsGene 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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NewsFirst-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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NewsNew 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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NewsImproving upstream fermentation with end-to-end automation
The automated system “significantly improved process control”, resulting in greater productivity of a small-molecule drug substance.