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Rare Disease Clinical Outcome Assessment Consortium launched
The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.
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Clinical Development
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Have your say on future UK clinical trial legislation
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on far-reaching proposals to revise the clinical trial legislation in the UK.
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Accelerating Clinical Trials in the EU (ACT EU) initiative launch
The new ACT EU initiative seeks to transform how clinical trials are initiated, designed and run in the European Union.
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Graft engineering sees potential to reduce GVHD risk in leukemia patients
New study shows risk of developing graft-versus-host disease (GVHD) in leukaemia patients reduced by removing naïve T cells from donor blood used for stem cell grafts.
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New year, new cell and gene therapy collaborations
Here we run down four new research collaborations in the cell and gene therapy sector, announced by Bayer, BMS, Pfizer and Moderna.
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Ensovibep shows promise as an antiviral for COVID-19
Phase II trial data suggests ensovibep (MP0420) significantly reduces SARS-CoV-2 viral load and reduces hospitalisation and death due to COVID-19.
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mRNA vaccine for Epstein-Barr Virus enters Phase I trial
The first patient dosed in Phase I study of Moderna’s mRNA-1189, a vaccine candidate for Epstein-Barr Virus (EBV).
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Dystrogen begins trial for Duchenne muscular dystrophy cell therapy
The first patient has been infused in the Phase I pilot study of DT-DEC01, a chimeric cell therapy for Duchenne muscular dystrophy.
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Enabling impactful breakthroughs and therapies
Linda De Jesus, Senior Vice President and Chief Commercial Officer at Azenta Life Sciences highlights the benefits of uniting and focusing efforts solely for the life sciences sector.
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The culmination of knowledge and experience equals a prized partner
Tim Mullane, President and COO of FUJIFILM Irvine Scientific, talks expansion, evolution and excellence.
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First drug for acute graft-versus-host disease prevention approved by FDA
BMS’s Orencia (abatacept) has been approved by the US FDA for prophylaxis of acute graft-versus-host disease (aGvHD) in patients aged two years plus.
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Application note: BIOBALL® Burkholderia cepacia complex strains performance testing for USP <60> growth promotion requirements
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
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UK regulator publishes guidance on use of real-world data to support clinical trials
Two new guidance documents, the first in a series to published by the MHRA, outline considerations when planning a randomised clinical trial using real-world data.
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Experimental gene therapy reverses sickle cell disease for three years
The gene therapy corrected the shape of some sickle cell patients' red blood cells and eliminated episodes of severe pain.
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Gene therapy sustains bleeding control in haemophilia A trial
Giroctocogene fitelparvovec had a mean annualised bleeding rate (ABR) of just 1.4 percent over two years, with no bleeding events in the first year post infusion.
