Podcast: Rare Disease Day: FDA guidance allowing advancement
It’s been a busy year for rare disease developers, with the US Food and Drug Administration (FDA) releasing several new…
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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Rare disease developers applaud clarity in FDA guidance
Stakeholders in the rare disease development community say that new guidance documents, released by the US Food and Drug Administration…
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J&J’s Caplyta doubles remission rate in MDD patients
Johnson & Johnson’s (J&J) Caplyta (lumateperone) plus antidepressants nearly doubled the likelihood of remission after six weeks, with benefit remaining…
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JPM26: Tryngolza set to become first wholly owned Ionis blockbuster
Ionis’ Tryngolza (olezarsen) is set to become the company’s first wholly owned blockbuster drug, CEO Brett Monia believes. Speaking at…
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JPM26: HIV pipeline dosing optionality gives Gilead advantage
Gilead’s range of treatments and prevention for human immunodeficiency virus (HIV), both on the market and in the pipeline, provides…
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GSK to file for approval of hep B drug on positive Phase III data
GSK’s triple-action investigational antisense oligonucleotide (ASO) candidate has demonstrated a clinically and statistically significant functional cure in chronic hepatitis B…
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Pharma positions itself for 2026 amid an evolving US landscape
After President Donald Trump’s administration took office in early 2025, a series of policy changes have directly impacted the pharma…
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Takeda to seek approval of plaque psoriasis pill on Phase III trial data
Takeda’s once-daily oral plaque psoriasis (PsO) drug has met all its endpoints in two pivotal trials, with the company set…
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Pfizer gains another obesity asset with $2bn deal for YaoPharma’s GLP-1RA
Pfizer has confirmed another push into the obesity market in the form of a licencing deal worth up to approximately…
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Potentially “groundbreaking” FDA gene therapy pathway leaves key issues unresolved
The US Food and Drug Administration’s (FDA’s) new pathway for gene therapies could be “groundbreaking” if applied broadly, though the…