Drug Development
After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM.
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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In a potential leap forward for sickle cell disease, Vertex moved closer to launching its one-time treatment for sickle cell disease and transfusion-dependent beta-thalassemia.
Cytokinetics is discontinuing the Phase III COURAGE-ALS trial in amyotrophic lateral sclerosis after its candidate reldesemtiv failed a planned interim analysis, the company announced Friday.
HUTCHMED has completed the rolling submission of its New Drug Application to the FDA for fruquintinib, its candidate for refractor metastatic colorectal cancer.
Ravi B. Parikh discussed how new FDA guidance on accelerated approval for cancer drugs will affect the space.
GSK will help commercialize Brexafemme (ibrexafungerp), currently approved to treat vaginal yeast infections and vulvovaginal candidiasis (VVC).
BIIB080 successfully reduced tau pathology in patients with early-stage disease across all six brain regions analyzed.
The RSV race has lost one high-profile contender as Janssen announced it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.
Tuesday, Viking Therapeutics released Phase I results for its weight-loss candidate VK2735, which demonstrated a good safety and tolerability profile and resulted in significant weight reductions.
Intra-Cellular Therapies’ Caplyta met its primary endpoint in the Phase III Study 403 trial, easing the burden of depressive episodes in patients with major depressive disorder or bipolar depression.
Bicycle Therapeutics and Novartis announced Tuesday they have inked a deal worth up to $1.7 billion to discover and develop targeted radioligand therapies in oncology.