Claiming Akebia agreement breach, Otsuka seeks to end anemia drug pact
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, […]
Otsuka Pharmaceutical is ending its alliance with Akebia Therapeutics, a move that comes less than two months after the FDA rejected their partnered anemia drug, […]
The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety […]
Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment […]
Shots: The P-III ASCEND program includes 5 studies i.e ASCEND-ND, D, ID, NHQ & TD studies evaluating efficacy & safety of daprodustat vs ESA in […]
A Roche drug that failed as a treatment for neurological disorders is now the lead program for Disc Medicines. CEO John Quisel said Roche’s clinical […]
“Lead poisoning still occurs in the United States despite extensive prevention efforts and strict regulations.” Ayurvedic supplements specifically marketed to pregnant women, for example, exceeded […]
Shots: The company has received an FDA’s CRL declining the approval of roxadustat’s NDA to treat anemia of CKD The FDA has requested to conduct […]
Shots: The global program includes two P-III studies assessing vadadustat (PO) vs darbepoetin alfa (inj.) in a ratio (1:1) in incident dialysis patients (Correction/Conversion) and […]
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