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 · Moderna’s mRNA cancer vaccine for solid tumours shows early signs of promise in interim data from a Phase I study.. The messenger ribonucleic acid (mRNA) specialist announced the vaccine has shown early signs of an immune response against cancer, with the shot triggering cancer-killing cells.
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 ...
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.
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.
GigaGen commences Phase I clinical trial of GIGA-2339 for HBV
Nov 20, 2024 · GigaGen, a subsidiary of Grifols, has commenced a Phase I dose escalation trial, with the first patient receiving a dose of GIGA-2339, a recombinant polyclonal drug candidate aimed at treating hepatitis B virus (HBV) infection. This trial is designed to evaluate the safety and tolerability of the drug in individuals with confirmed chronic HBV infection.
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.
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 ...