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Haemophilia treatment with new delivery method approved
The US FDA has authorised the first treatment for haemophilia A or B that is administered via a pre-filled pen or syringe.
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Drug Safety
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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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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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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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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.
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First-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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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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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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New 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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eBook: From Vial to Prefilled Syringe
Simplify your move from a vial to a prefilled syringe – lifecycle planning for containment and delivery of biologics drug products
