Drug Development
After BrainStorm Cell Therapeutics withdrew its BLA in October 2023 for NurOwn, the company announced Tuesday that the FDA has agreed to the design of a Phase IIIb trial for its amyotrophic lateral sclerosis candidate under a Special Protocol Assessment.
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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Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.
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The company reported mid-stage and late-stage trial victories, one in small-cell lung cancer and another in colorectal cancer, as part of its second-quarter earnings on Thursday. No specific data was provided.
Early research and anecdotal evidence indicate that the popular diabetes and obesity drugs could treat some patients with addictive disorders.
The biopharma company reported sales of $2.24 billion in the second quarter for the cystic fibrosis treatment, beating analysts’ estimate, after it won FDA approval in children ages two to five in April.
The settlement agreement between the companies follows three patent-infringement lawsuits filed by Bristol-Myers Squibb over the blockbuster cancer immunotherapies.