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.
Viridian Therapeutics' stock jumps after Phase III trial met all …
Sep 11, 2024 · Viridian Therapeutics ’s veligrotug has met all primary and secondary endpoints in a Phase III trial in active thyroid eye disease (TED). Previously known as VRDN-001, veligrotug won in the Phase III THRIVE trial (NCT05176639). It also boasted positive safety data in patients with TED, which is also known as Graves’ disease. The news saw ...
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 ...
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 data will help to shape a pivotal trial …
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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 ...
Mounjaro (tirzepatide) for the Treatment of Type 2 Diabetes, USA
Jun 19, 2024 · Mounjaro ™ (tirzepatide) is a dual-targeted, injectable, sustained-release therapy indicated for the treatment of type 2 diabetes (T2D) in adults as an adjunct to diet and exercise.. Developed by Eli Lilly, a pharmaceutical company based in the US, Mounjaro is the first and only once-weekly glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 …