News
Regeneron's trial fails to reach statistical significance for primary endpoint
2+ hour, 23+ min ago (204+ words) Regeneron Pharmaceuticals has reported that its Phase III trial assessing fianlimab (a LAG-3 inhibitor) and cemiplimab (a PD-1 inhibitor) for metastatic melanoma failed to reach statistical significance for the primary endpoint. This combination is evaluated as a first-line treatment for…...
How to tackle regulatory pathways and obstacles for clinical trials in UK and Ireland
2+ day, 17+ hour ago (217+ words) An upcoming conference will feature in-depth discussions on the clinical trials landscape is evolving in the UK and Ireland. The upcoming Outsourcing in Clinical Trials UK & Ireland 2026 conference, taking place on 910 June 2026 in London, UK, will bring together leading clinical…...
Participant enrolment and retention key to clinical trial derisking
2+ day, 17+ hour ago (417+ words) With rising complexity in clinical trials creating additional patient burden, innovative solutions can be leveraged to mitigate risk. As the complexity of clinical trials continues to grow, enhancing patient centricity, improving site and contract research organisation (CRO) collaboration and leveraging…...
REGENXBIO to push for accelerated approval of DMD gene therapy
2+ day, 18+ hour ago (377+ words) REGENXBIO touted data from the Phase III portion of a study that showed higher benefit that Elevidys. REGENXBIO is set to apply for US accelerated approval of its Duchenne muscular dystrophy (DMD) gene therapy after it showed benefit in a Phase…...
Nonprofits join forces to debut marketplace for shelved CGTs
2+ day, 18+ hour ago (416+ words) OTXL's COO, Beth White, notes that the CGTxchange platform could revitalise CGT programmes that would otherwise have been indefinitely put on ice. The American Society of Gene & Cell Therapy (ASCGT) and Orphan Therapeutics Accelerator (OTXL) have teamed up to launch…...
Biopharma industry endorses Pazdur for FDA commissioner role
2+ day, 23+ hour ago (385+ words) Hundreds of biopharma leaders say Dr Richard Pazdur has the necessary qualities to lead the FDA amid a crisis of confidence. With the leadership role of the US Food and Drug Administration (FDA) vacant following Marty Makary's resignation earlier this…...
Biogen forges on with Alzheimer's therapy development despite Phase II miss
2+ day, 23+ hour ago (600+ words) The anti-tau therapy demonstrated the strongest efficacy signal at the low 60mg Q6 M dose. Biogen is firing up a registrational programme for its tau-focused Alzheimer's disease therapy, diranersen, despite the drug missing its primary endpoint in a mid-stage study. During the…...
Massive Bio and Just Worldwide to expand cancer trial access
3+ day, 1+ hour ago (306+ words) Massive Bio has signed a strategic partnership with Just Worldwide to connect more cancer patients to clinical studies. Under this partnership, Just Worldwide will utilise its engagement infrastructure to increase awareness of Massive Bio's clinical trials. The company will onboard…...
Three Ps A trials to watch in 2026
3+ day, 1+ hour ago (912+ words) As rheumatologists prepare for EULAR 2026, Clinical Trials Arena takes a look at the most promising drugs in late-stage development for Ps A. With the European Alliance of Associations for Rheumatology's (EULAR) 2026 meeting less than a month away, physicians, researchers and other…...
Podcast: UK targets speedy clinical trial set-ups with 150-day benchmark
3+ day, 18+ hour ago (158+ words) National Institute for Health and Care Research (NIHR) senior programme director Joanna Calvert discusses the agency's role in achieving the 150-day metric. Faced with growing competition in the global clinical trials landscape, many countries are reforming regulatory frameworks in a…...