Drug Development
Hit with lower sales of its COVID-19 antiviral Veklury and the weak performance of its HIV franchise, Gilead Sciences reported a 4% year-over-year revenue loss in the fourth quarter of 2023.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
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Citing lack of efficacy evidence, the FDA rejected Cytokinetics’ heart failure hopeful omecamtiv mecarbil in a decision announced Tuesday evening.
Wednesday, the FDA’s VRBPAC agreed that GSK’s respiratory syncytial virus vaccine candidate is safe and effective in older adults.
Aptinyx’s NYX-458 fell short of the primary endpoint in a Phase II trial of patients with cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies.
Theravance Biopharma is discontinuing research activities for its JAK inhibitor program in lung inflammation and reducing its headcount by about 17%.
Researchers at Kyverna Therapeutics and Cabaletta Bio hope to repurpose CAR-T cell therapy for patients with autoimmune diseases.
Billy Dunn, director of the FDA’s Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.
ALS is the 5,000-piece jigsaw puzzle of the therapeutic world. As the regulatory edges come together, new research pieces are also connecting.
The hits kept coming for the sickle cell disease space last week as the FDA placed a full clinical hold on Fulcrum Therapeutics’ Investigational New Drug application FTX-6058.
Rezpegaldesleukin, Lilly’s and Nektar Therapeutics’ candidate for systemic lupus erythematosus, fell short of its primary efficacy endpoint in the Phase II ISLAND trial.
Novartis recently announced it is returning a Phase II-ready nonalcoholic steatohepatitis asset to Pliant. The program stemmed from a 2019 collaboration.