Drug Development
Stringent regulation, manufacturing costs and absence of price control contribute to high GLP-1 agonist costs in the U.S. Patients could go to other countries for cheaper treatment.
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 FDA has rejected Soligenix’s NDA for HyBryte (synthetic hypericin), a therapeutic developed to treat early-stage cutaneous T-cell lymphoma.
Clene, Inc. posted new data from a Phase II trial of CNM-AU8 in multiple sclerosis featuring MRI results it claims reinforce neurological improvements reported in November 2022.
Bristol Myers Squibb and 2seventy bio published positive results Friday from a pivotal Phase III trial of Abecma in multiple myeloma patients who had received two to four prior lines of therapy.
Due to safety concerns, Aristea Therapeutics announced Friday that it was discontinuing the development of its Phase II lead program. As a result, the San Diego-based biotech is also dissolving its business.
Eliem Therapeutics is dropping a depression drug candidate and laying off 55% of staff in an attempt to stretch its cash runway to 2027.
Amid growing demands for generic versions of Vertex’s Trikafta, the company provided an update on the late-stage clinical development of its next-in-class triple combination for cystic fibrosis.
Bristol Myers Squibb has returned the rights for interleukin-12 immunotherapy program DF6002 back to its original owner, Dragonfly Therapeutics, the companies announced Monday.
Data from a Phase III study show Genentech’s crovalimab is non-inferior to AstraZeneca’s Soliris, the current standard of care in paroxysmal nocturnal hemoglobinuria (PNH).
Merck and Nectin Therapeutics announced a research collaboration agreement to study the safety and efficacy of Nectin’s investigational antibody in locally advanced and metastatic solid tumors.
Industry leaders say the second generation of interventions for nonalcoholic steatohepatitis is likely to succeed where first-generation approaches stumbled.