Drug Development
The Swiss pharma will seek accelerated approval for iptacopan in IgA nephropathy next year after the complement blocker demonstrated promising efficacy in the Phase III APPLAUSE-IgAN study.
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 ordered Avidity Biosciences to halt clinical trial enrollment after a patient suffered a “serious adverse event” testing the company’s candidate drug for myotonic dystrophy type 1.
The FDA has granted a rolling review to CRISPR Therapeutics and Vertex’s exa-cel, a potential one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
During an R&D presentation Tuesday, Transgene executives and oncology experts highlighted promising therapeutic progress in its programs - focusing on its developmental cancer vaccines.
Daiichi Sankyo won approval in Japan for Ezharmia, making it the first dual inhibitor of EZH1 and EZH2 to receive regulatory approval for ATL.
Equillium, 9 Meters Biopharma and ABVC Biopharma have something to say about lupus, short bowel syndrome and ADHD.
The announcement follows a subgroup analysis of the Phase III SOLO3 trial which showed patients treated with Lynparza saw a 33% greater risk of death than controls who received standard chemotherapy.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
September 24 is World Cancer Research Day, and September is Childhood Cancer Awareness Month. BioSpace spoke with leaders from three companies tackling pediatric glioma.
Recently published research into repairing nerve damage caused by injury may also pay off in treating some of the most vexing neurodegenerative diseases like Alzheimer’s.
NovoCure announced the launching of a U.S.-based arm to focus on and attempt to grow its glioblastoma (GBM) business and increase its patient population.