IDWeek 2024: Moderna’s norovirus vaccine mRNA-1403 shows …
Oct 21, 2024 · 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 healthcare burden.
MHRA expects new UK clinical trial regulation implementation by …
Oct 16, 2024 · 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.
GSK ceases HSV vaccine - a chance for Moderna and BioNTech
Sep 25, 2024 · 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 GSK’s decision not to ...
Merus’ Bizengri granted FDA accelerated approval to treat NRG1
Dec 5, 2024 · Merus’ Bizengri (zenocutuzumab-zbco) has received accelerated approval from the US Food and Drug Administration (FDA), marking “an important milestone” in the treatment of cancers with a neuregulin 1 (NRG1) gene fusion, according to the principal investigator of the company’s ongoing trial.. The drug is the first systemic therapy approved by the FDA for the treatment of advanced ...
BlueRock reports positive data from Parkinson’s cell therapy trial
Sep 30, 2024 · The primary endpoint of safety and tolerability was assessed at 12 months, alongside evaluations of cell survival and motor effects. The results have shown that bemdaneprocel’s safety profile at 24 months was in line with prior data, indicating good tolerance and no adverse events directly related to the therapy.
FDA lifts clinical hold on Avidity’s lead antibody conjugate therapy …
Oct 4, 2024 · The US Food and Drug Administration (FDA) has lifted the partial clinical hold on Avidity Biosciences’ investigational drug, delpacibart etedesiran (del-desiran).. In 2022, the US regulatory agency placed a partial hold after a report of a serious adverse event in a newly enrolled patient in the Phase I/II MARINA trial (NCT05027269), which evaluated del-desiran in patients myotonic dystrophy ...
Cassava Sciences: Phase III trials storm ahead amid controversy
Oct 9, 2024 · In a related order, the SEC also charged Cassava consultant, Dr. Hoau-Yan Wang, an associate medical professor at the City University of New York’s (CUNY) Medical School and the therapeutic’s co-developer, for manipulating the reported clinical trial results.
Lebrikizumab, Tralokinumab and Dupilumab compete in AD space
Oct 8, 2024 · 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.
Pfizer reports data from prostate cancer combination therapy trial
Oct 11, 2024 · Participants were divided into two cohorts: an all-comers group and those with homologous recombination repair (HRR) gene mutations. Radiographic progression-free survival (rPFS) was the trial’s primary endpoint while secondary endpoints comprised OS, objective response rate (ORR), duration of response (DOR) and prostate-specific antigen (PSA) response.
GSK reports positive findings from Phase III RSV vaccine trial
Oct 9, 2024 · Following the initial season, 12,469 individuals from the vaccine group were re-randomised to receive either the RSV vaccine or a placebo. The study then measured the vaccine’s efficacy over the subsequent two RSV seasons, with the results indicating a cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD.