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IDWeek 2024: Moderna’s norovirus vaccine mRNA-1403 shows …
2024年10月21日 · At IDWeek 2024, Moderna presented interim results from an ongoing Phase I/II, randomised, observer-blind, placebo-controlled, dose-ranging trial (NCT05992935) for mRNA-1403, a prophylactic vaccine candidate under investigation for norovirus (NoV) infections. As one of the leading causes of acute gastroenteritis worldwide, NoV is associated with a substantial …
Most significant clinical trials of 2024
2024年12月23日 · Most significant clinical trials of 2024. From GLP-1RA and HIV PrEP successes, to flops in DMD and Alzheimer’s, Clinical Trials Arena rounds up the biggest trial read outs of 2024.
GSK ceases HSV vaccine - a chance for Moderna and BioNTech
2024年9月25日 · GSK recently announced the discontinuation of its herpes simplex virus (HSV) therapeutic vaccine candidate, GSK3943104, following the failure of a Phase I/II clinical trial to meet its primary efficacy goals.. The vaccine aimed to reduce lesions in patients with recurrent genital herpes – a high unmet medical need. Although deemed safe, its lack of efficacy led to …
A schizophrenia win for BMS’ Cobenfy, but challenges lie ahead
2024年10月1日 · Cobenfy is also being developed as an adjunctive therapy in patients who have an inadequate response to atypical antipsychotic monotherapy. The ongoing Phase III ARISE trial is a six-week, randomised, double-blind, placebo-controlled, multicentre, outpatient study in patients with schizophrenia with an inadequate response to their current atypical antipsychotic …
ESMO 2024: Moderna’s mRNA solid tumour vaccine shows early …
2024年9月13日 · The vaccine was safe and well tolerated in the first cohort, with adverse events (AEs) including fatigue, injection site pain and fever. Researchers are asking for the interim data to be treated with caution at this early stage due to the small sample size and primary endpoint being safety and dose-determining.
MHRA expects new UK clinical trial regulation implementation by …
2024年10月16日 · Between 2022 and 2023, the MHRA undertook a consultation period surrounding a new legislative framework for clinical trials in the UK. The MHRA said the new regulation will ensure patients and their safety are the focus of all clinical trials, while bringing the benefits of clinical trials to everyone.
Novartis’ SMA therapy trial meets primary endpoint
2024年12月31日 · It randomised over 100 subjects to receive either gene therapy by intrathecal injection or a sham procedure. The study’s primary endpoint was met, indicating an increase in total Hammersmith Functional Motor Scale – Expanded (HFMSE) scores from baseline.
GSK's depemokimab shows promise in Phase III CRSwNP trials
2024年10月15日 · UK-based pharmaceutical company GSK has announced positive results from the Phase III ANCHOR-1 and ANCHOR-2 clinical trials of depemokimab in adults with chronic rhinosinusitis with nasal polyps (CRSwNP).. The full analysis set included 143 patients in the depemokimab arm and 128 in the placebo arm in ANCHOR-1, as well as 129 patients treated …
Otsuka’s sibeprenlimab shows promise in Phase III trial
2024年10月23日 · It aims to assess the efficacy and safety of sibeprenlimab 400mg administered every four weeks subcutaneously, in comparison to a placebo. An independent data monitoring committee conducted a pre-specified interim analysis, in which it concluded that sibeprenlimab led to a significant reduction in the 24-hour urine protein-to-creatine ratio (uPCR) after nine …
Lebrikizumab, Tralokinumab and Dupilumab compete in AD space
2024年10月8日 · Lebrikizumab, tralokinumab and dupilumab to compete in atopic dermatitis space. The separation of Ebglyss from Dupixent and Adbry/Adtralza will depend on real-world clinical benefits, patient experience and cost-effectiveness.