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EMA publishes EU strategy to 2028
The draft strategy, open for an eight-week public consultation, will help guide the direction of the network over the next few years.
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Industry Insight
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Advancing environmental monitoring systems for CGT manufacturing
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
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CPHI Milan 2024: everything you need to know
CPHI Milan takes place in October, covering a wide range of topics from packaging and drug delivery to integrated pharma.
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Improving packaging integrity of pharmaceutical borosilicate glass vials
The study offers promising data on strengthening borosilicate medical glass vials using ion-exchange, especially as there is limited research in this area.
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First 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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Enhancing 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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Future of oral small molecule drugs – addressing potential in multiple sclerosis
Advances in selectivity, safety, and patient convenience, oral small molecule drugs continue to be a key focus in drug development. Here, Dr Andreas Muehler and Daniel Vitt, PhD, the co-founders of Immunic Therapeutics, discuss the potential of Vidofludimus calcium as a breakthrough treatment for autoimmune diseases.
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Quality from the start: designing a scalable AAV production platform
This Feature Partnership discusses AAVs and how manufacturers can overcome the key development challenges and create a scalable AAV production platform.
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European 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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Patient insights into the decentralisation of clinical trials
While a trial is a part of pharma research, despite industry advancement, the patient experience is not often considered for innovation.
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How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging
This feature partnership covers how pharma companies can ensure they are end-to-end compliant with Annex 1 for their primary packaging via a robust CCS.
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European Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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Genentech 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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Optimising 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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Radiopharmaceutical 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.
