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European Pharmaceutical Review Issue 1 2025
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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Clinical Trials
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European Commission approves Rytelo for LR- MDS-related anaemia
The European marketing authorisation offers a new treatment option for patients with transfusion-dependent anaemia in lower-risk myelodysplastic syndromes (LR-MDS), who are unresponsive to erythropoiesis-stimulating agents.
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NICE recommends innovative endometriosis pill
Approximately 1,000 eligible NHS patients could benefit from the new endometriosis treatment annually.
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Bristol Myers Squibb to acquire 2seventy bio
The proposed acquisition, worth nearly $300 million, could help to advance cell therapy in the oncology field.
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Investigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
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Alzheimer’s drug requires strengthened pharmacovigilance approach
Ongoing real-world safety and effectiveness monitoring of the Alzheimer’s drug lecanemab is needed to protect patients long-term, drug safety researchers urge.
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Safety reporting in clinical trials: six core considerations for success
5 March 2025 | By PPD™ clinical research business of Thermo Fisher Scientific
This webinar will provide guidance in navigating the terrain of pharmacovigilance, including regulatory challenges, and gain a deeper understanding of the pivotal role played by safety reporting in clinical research.
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Preparing for a new era in the rare disease sector
To mark Rare Disease Day 2025, EPR interviewed Christina Gkousgkouni, Head of Rare Diseases for Central South Europe, Sanofi.
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NICE recommends novel immunotherapy for leukaemia
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
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Fast tracking clinical success: choosing the right Fill & Finish CDMO
24 February 2025 | By Adragos Pharma
Selecting the right Fill & Finish CDMO can make or break a product’s commercial success. In this webinar, join industry experts to explore key strategies for navigating this crucial stage, ensuring optimal efficiency where it matters most.
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First-in-human data for gene therapy signals potential in childhood blindness
Developed and manufactured under a Manufacturer’s ‘Specials’ Licence (MSL), the gene therapy could provide a novel treatment option for paediatric patients at the earliest stage of the rare eye disease.
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First-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
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Biologic could reduce treatment burden for children with haemophilia A
New data suggests that once-weekly prophylaxis bispecific antibody treatment could provide an efficient and convenient option for young patients with haemophilia A.
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Novel drug approved for diabetes-related vision loss
The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.
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Moderna reports record for UK clinical trials in 2023/24
The announcement follows the completed construction of Moderna’s MITC and progress in its long-term partnership with the UK government.
