Drug Development
Interim data from the company’s late-stage clinical trial suggests its cell therapy treatment for heart failure likely won’t meet the primary efficacy endpoint, BioCardia announced on Tuesday.
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.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
Shares of AnaptysBio are down more than 16% after imsidolimab failed to meet the endpoint in a Phase II trial assessing its efficacy in hidradenitis suppurativa.
Sanofi announced FDA approval of Xenpozyme for adult and pediatric patients with the rare genetic disease acid sphingomyelinase deficiency, often referred to as Niemann-Pick disease.
Researchers at the Wuhan Institute of Virology (WIV), which is potentially linked to the origins of COVID-19, reported the discovery of a novel DNA virus in animals in the journal Virologica Sinica.
Day One Biopharmaceuticals aims to provide a business solution to a moral problem: the inequity in pediatric oncology drug development.
Clover’s SCB-2019 showed a robust immune response to the Omicron BA.5 sub-variant, while BrainsWay, TikoMed and more provide updates on their businesses and pipelines.
Amgen announced Tuesday that initial Phase III data of Lumakras in KRAS G12C-mutated NSCLC met the primary endpoint of progression-free survival.
Aria Pharmaceuticals secured six provisional patents to cover the lead drug candidates for its lupus, idiopathic pulmonary fibrosis and chronic kidney disease research programs.
Jounce Therapeutics announced that a Phase II trial assessing a combination treatment for non-small cell lung cancer failed to meet its primary endpoint.
Umoja CEO Andy Scharenberg spoke with BioSpace about the company’s unique tri-platform approach to immunotherapy which aims to attack and destroy hematologic and solid organ-based tumors.
Alnylam Pharmaceuticals reported positive Phase II results for cemdisiran, an RNA interference (RNAi) drug developed to treat IgA nephropathy.