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Samsung Bioepis’ investigational Humira biosimilar, SB5, demonstrated equivalence to the reference product in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy in a pivotal Phase 3 clinical trial, the South Korean drugmaker said Wednesday. Read More
The FDA is adding plasma fibrinogen as a prognostic biomarker for patient selection in clinical trials involving chronic obstructive pulmonary disease and a high risk of death. Read More
Vertex Pharmaceuticals’ Orkambi has been approved as the first drug intended to treat cystic fibrosis in patients who have two copies of a specific mutation, the FDA announced Friday. Read More
A federal judge has ordered Apotex to pay AstraZeneca $98.5 million for infringing on patents to the latter’s heartburn drug Prilosec, following an appellate decision affirming most of a $76 million award from a 2013 ruling. Read More