Novavax Inc. started a large late-stage study of the company’s experimental Covid-19 vaccine in the United States after delaying the trial twice due to issues in scaling up the manufacturing process.
AstraZeneca and Amgen said their experimental asthma drug tezepelumab failed to meet the main goal of reducing patients’ dependence on steroids, while keeping the respiratory condition in check in a late-stage trial.
Moderna announced plans to submit the company’s request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for the Covid-19 vaccine mRNA-1273 on Nov. 30.
A Phase III trial of NurOwn (MSC-NTF cells), BrainStorm Cell Therapeutics’ investigational therapy for amyotrophic lateral sclerosis, did not find a statistically significant difference between the product and placebo for improving scores on a revised ALS functional rating scale (ALSFRS-R) that measures the severity of the disease.
Cytokinetics Inc. said a pivotal trial of the experimental heart failure drug the company is developing with Amgen Inc. showed a slightly higher rate of cardiovascular-related death for patients given the medicine compared to those on a placebo.
A recent study shows that Bristol Myers Squibb’s oral tyrosine kinase 2 (TYK2) inhibitor deucravacitinib was associated with noticeable improvements in signs and symptoms of psoriatic arthritis compared with placebo.
Shares of Calliditas Therapeutics soared in trading after the company announced positive Phase III data from a study of Nefecon in IgA nephropatjhy (IgAN), an autoimmune renal disease.
Additional findings from Biogen’s Phase II LILAC study show the biotech company’s lupus drug candidate BIIB059 is superior to placebo for reducing joint disease activity in patients with systemic lupus erythematosus (SLE).
Regeneron Pharmaceuticals Inc.’s coronavirus antibody cocktail – the experimental treatment that U.S. President Donald Trump received – significantly reduced medical visits in a trial of nearly 800 patients with mild-to-moderate Covid-19.
Bristol Myers Squibb announced that CheckMate -274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met primary endpoints of improving disease-free survival (DFS) versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1% (programmed death-ligand 1).