Drug Development
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints.
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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The Swiss pharma is expanding its neuroscience pipeline with an upfront $500 million payment to DTx Pharma and additional payments of up to $500 million upon completion of certain milestones.
Following disappointing topline data, BridgeBio’s acoramidis has scored a late-stage win in transthyretin amyloid cardiomyopathy, leading to significant survival and quality of life benefits.
Full data for Eli Lilly’s Phase III TRAILBLAZER-ALZ 2 study, presented Monday at the 2023 Alzheimer’s Association International Conference, confirm positive results announced in May.
In a Phase I trial, Caribou’s allogeneic CAR-T cell therapy candidate induced high rates of treatment response in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
After beginning July with a splash in the Alzheimer’s space, the FDA is expected to make three decisions during the next two weeks; two for cancer and one for a viral skin disease.
Recent data from the Phase III study of donanemab emphasize a correlation between amyloid and tau. Experts say a greater understanding of this link could further Alzheimer’s drug development.
Data from the OCARINA II trial shows that a 10-minute subcutaneous injection of Ocrevus achieves similar pharmacokinetics as the typical hours-long intravenous infusion in multiple sclerosis patients.
The FDA recently approved the first cellular therapy for Type 1 diabetes and others may not be far behind. But experts say challenges still exist to the widespread application of these treatments.
The company’s ruxolitinib cream Opzelura led to higher rates of treatment success in children with atopic dermatitis than with a control cream.
Severe respiratory problems killed seven patients and affected five others, though the company said that most of these were likely unrelated to the drug.