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.
Zepbound will dominate obesity market following SURMOUNT-5 …
Jan 2, 2025 · The Phase IIIb SURMOUNT-5 trial found that Eli Lilly’s Zepbound was more effective in promoting weight loss than Novo Nordisk’s Wegovy. Credit: Ciara Kimsey / Shutterstock. Following positive results from its SURMOUNT-5 trial, Eli Lilly’s Zepbound (tirzepatide) will surpass Novo Nordisk’s ...
Daiichi Sankyo doses first subject in Phase III AML therapy trial
Dec 11, 2024 · The global trial is anticipated to enrol nearly 700 subjects across North America, South America, Australia, Europe, and Asia. Credit: Volha_R/Shutterstock. Daiichi Sankyo has announced the dosage of the first subject in the randomised Phase III QuANTUM-Wild trial of oral Vanflyta (quizartinib) in ...
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.
Sanofi's trial of rilzabrutinib for thrombocytopenia meets endpoint
Dec 9, 2024 · Sanofi has reported that the Phase III LUNA 3 trial of rilzabrutinib for the treatment of persistent or chronic immune thrombocytopenia (ITP) in the adult population, met its primary endpoint.. The primary endpoint, durable platelet response was observed in 23% of the therapy-treated adults with this rare immune-mediated disease.
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 ...
AHA 2024: Zerlasiran shows promising Phase II results for elevated ...
Nov 19, 2024 · Dr. Steven Nissen, MD chairman and chief academic officer of the Heart and Vascular Institute at the Cleveland Clinic and professor of medicine at the Lerner College of Medicine, reported that subcutaneous injections of 300mg or 450mg of zerlasiran, administered every 16 or 24 weeks, reduced time-averaged Lp(a) levels by 80% to 85% over a follow-up period of 36 to 60 weeks.
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 ...
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 ...
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.