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 …
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.
ESMO 2024: Moderna’s mRNA solid tumour vaccine shows early …
Sep 13, 2024 · 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.
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.
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.
A schizophrenia win for BMS’ Cobenfy, but challenges lie ahead
Oct 1, 2024 · 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 treatment.
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 …
Moderna doses first subject in mRNA norovirus vaccine trial
Oct 1, 2024 · The observer-blind, randomised, placebo-controlled study has begun recruitment and will expand its recruitment efforts worldwide. It is expected to enrol around 25,000 adults aged 18 years and older from various geographical regions.
Hepatitis B: Four trials to watch over the next 12 months
Jul 28, 2023 · While Dr Antonio Bertoletti, professor at the Duke-NUS Medical School in Singapore and an infectious disease doctor who has been working on Hepatitis B trials for 30 years, said he thinks that it is more important for trials in Hepatitis B to find patient populations in which they may be most effective rather than seek a one-size fits all treatment.