From real to regulatory: why RWD needs trial-grade standards
As the US Food and Drug Administration (FDA) becomes more receptive to the use of real-world data (RWD) in drug…
All articles by Abigail Beaney
Abigail Beaney
Abigail Beaney is the editor of Clinical Trials Arena. Abigail has expertise in clinical trial regulation, trial design, outsourcing, and cell and gene therapies. Abigail also has covered news and has a wealth of knowledge across several therapy areas including neurodegenerative, infectious and metabolic diseases. Abigail holds a first-class BA (Hons) degree in Journalism from the University of Central Lancashire in the United Kingdom. She has also obtained the National Qualification in Journalism through the UK's media industry body, the National Council for the Training of Journalists. Contact Abigail
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Boehringer Ingelheim’s kidney drug reduces proteinuria by 40% in Phase II trial
Boehringer Ingelheim’s apecotrep has led to a 40% reduction in proteinuria, a key indicator associated with kidney damage, in patients…
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FDA puts REGENXBIO gene therapy trials on hold after brain tumour
The US Food and Drug Administration (FDA) has placed a clinical hold on trials of two of REGENXBIO’s investigational gene…
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Intellia Therapeutics to resume dosing of gene therapy in Phase III trial
Intellia Therapeutics has been given approval to resume patient enrolment and dosing in a Phase III trial of its gene…
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CVRx’s stock up as heart failure device to be trialled in expanded patient group
CVRx’s stock has risen nearly 20% after the company revealed that its heart failure device is set to be investigated…
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Trial acceleration: AI supports progress, relationships drive success
Trial acceleration has been a topic of conversation for the pharmaceutical sector for years and as technology advances, it is…
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Corcept’s stock up as relacorilant meets OS goal in Phase III ovarian cancer trial
Corcept Therapeutics’ stock has risen 14% after its selective cortisol modulator relacorilant met its overall survival (OS) goal in a…
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IntraBio’s ataxia-telangiectasia drug meets endpoints in pivotal trial
IntraBio will head to regulators after its neurological rare disease drug met primary and secondary endpoints in a Phase III…
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Tanabe Pharma’s dersimelagon hits success in Phase III EPP and XLP trial
Tanabe Pharma America’s oral melanocortin-1 receptor (MC1R) agonist has met the primary endpoint in a Phase III trial in patients…
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ImmunityBio’s allogeneic CD19 cell therapy shows complete response beyond 15 months
ImmunityBio’s stock is up after its off-the-shelf allogeneic CD19 chimeric antigen receptor natural killer cell therapy (CAR-NK) showed over 15…