Biomea’s stock bounces back as FDA lifts clinical hold on diabetes …
Sep 27, 2024 · Biomea Fusion’s stock is on the up after the company plans to resume two clinical trials evaluating its type 1 and 2 diabetes therapy after the US Food and Drug Administration (FDA) lifted a full clinical hold. In June, the US regulatory agency paused the trials of BMF-219 after reports of potential drug-induced hepatotoxicity emerged.
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Novo Nordisk reports positive data from part one of semaglutide trial for MASH. ESSENCE is a double-blinded, 240-week study that involves 1,200 adults with MASH and stage two or three liver fibrosis.
Gilead’s lenacapavir: HIV prospects strongest in long-acting …
Aug 25, 2021 · Gilead’s lenacapavir will find its strongest niche as a long-acting HIV combination treatment, experts said. Manasi Vaidya August 25, 2021. Gilead announced a collaboration with Merck in March to study lenacapavir with islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), which is also a new drug class in HIV.
Longboard begins Phase III Dravet syndrome treatment trial
Sep 27, 2024 · Longboard Pharmaceuticals has commenced the international Phase III DEEp SEA Study of its investigational asset bexicaserin (LP352) for treating seizures in Dravet syndrome patients. The placebo-controlled, double-blind trial will enrol approximately 160 subjects between the ages of two and 65 years. LOA and PTSR Model - BMB-101 in Dravet ...
Top Ongoing mRNA Herpes Vaccine Trials - Clinical Trials Arena
Feb 2, 2023 · Pfizer and Moderna eye seasonal influenza. The two largest mRNA vaccine trials with readouts in 2023 are for seasonal influenza. First up, Moderna’s 6,102-patient, Phase III trial of mRNA-1010 (NCT05415462) has immunogenicity data expected in Q1 2023. The trial is testing mRNA-1010 against an active comparator vaccine, with primary endpoints ...
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News - Clinical Trials Arena. Adapting diabetes clinical trials to embrace underrepresented communities. Mapping out strategies to overcome challenges in clinical research. Q2 2024 update: social responsibility related hiring actvity in the pharma industry. Q2 2024 update: environmental sustainability related hiring actvity in the pharma industry.
Mpox: Three ongoing vaccine trials to watch
Sep 19, 2024 · Moderna is trialling its mRNA mpox vaccine in a Phase I/II trial (NCT05995275) assessing the safety, tolerability, and immunogenicity of mRNA-1769 in healthy adults. mRNA-1769 is an mRNA vaccine being trialled for the prevention of mpox and smallpox. The trial is taking place at sites across the UK and Moderna said the …
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Analysis - Clinical Trials Arena. News. Analysis. Sectors. Themes. Insights. Companies. Futureproofing supply chains in an evolving pharmaceutical industry . Transforming CML patient monitoring with ICON’s innovative RNA-based NGS assay.
Hepatitis B: Four trials to watch over the next 12 months
Jul 28, 2023 · Hepatitis B immune globulin (Hepatect, Nabi-HB, Zutectra, Neohepatect, Fovepta) contains mainly immunoglobulin G and acts as passive immunising preparation. The two cohorts are HBsAg positive and HBeAg negative, with one group having had no treatment while the other group will have been treated with anti-HBV NUC for at least 12 months before ...
Contract Research Organizations for the Clinical Trials Industry
Within the healthcare industry, CROs offer a range of services for various stages of product development, clinical trial, review and marketing. Some of the current industry leading services include, without necessarily being limited to: Formulation expertise in the research and development stage. Preclinical and clinical studies stage: site ...