All Clinical Development articles – Page 8
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NewsNew analysis sets stage for improved UK clinical trials
Observations from the report will help the MHRA to strengthen clinical research and lay the foundation for accelerated innovation and medicine delivery to patients in the UK.
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NewsGSK to advance antibody medicines for neurodegenerative diseases
The licensing agreement will support development of medicines for delivery across the blood-brain barrier to treat neurological disorders like Alzheimer’s and Parkinson’s.
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ArticleThe key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
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OpinionAI in pharmaceutical development: hype or panacea?
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
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NewsEMA proposes streamlined approach for biosimilar development
In certain cases, analytical comparability exercises and PK data could be sufficient for demonstrating biosimilarity, the EMA highlights in its new paper.
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NewsNovo Nordisk gains rights to novel small molecule inhibitor
As part of the agreement with Novo Nordisk, Lexicon Pharmaceuticals is eligible for total of $1 billion in upfront and potential milestone payments, alongside royalties.
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ReportPharma Horizons: Artificial Intelligence
EPR’s latest Pharma Horizons report explores the latest advances in artificial intelligence (AI) for drug and clinical development, regulation and more.
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NewsFDA approves first-in-class oral antibiotic
The drug is the first in a new class of oral antibiotics for uncomplicated urinary tract infections in nearly three decades.
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NewsMSD to advance investigational Lp(a) inhibitor in nearly $2b deal
The new license agreement will support development of a potential additional treatment option for patients at risk of atherosclerosis.
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ArticleEuropean 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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NewsEuropean 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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NewsNICE recommends innovative endometriosis pill
Approximately 1,000 eligible NHS patients could benefit from the new endometriosis treatment annually.
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NewsBristol 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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NewsInvestigational 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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NewsAlzheimer’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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NewsCHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
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ArticlePreparing 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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NewsNICE 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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NewsFirst-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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NewsWater-based reactors offer pharmaceutical industry a safer alternative to toxic solvents
The breakthrough promises to transform pharmaceutical manufacturing by enabling chemical reactions in water, reducing reliance on hazardous organic solvents.