Worried that doctors eager for new gout treatments would prescribe Regeneron's Arcalyst (rilonacept) for high-risk patients with aggressive or refractory disease, populations for which there is a lack of data, the US FDA's Arthritis Advisory Committee on 8 May refused to back the drug as a treatment for the condition.
Worried that doctors eager for new gout treatments would prescribe Regeneron's Arcalyst (rilonacept) for high-risk patients with aggressive or refractory disease, populations for which there is a lack of data, the US FDA's Arthritis Advisory Committee on 8 May refused to back the drug as a treatment for the condition.
The committee voted 11-0 that Regeneron's efficacy and safety data failed to support the approval of a subcutaneous once-weekly 80mg...
The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.
Based on first positive results for any quarterly IL-6 inhibitor, company plans to initiate Phase III cardiovascular outcomes trial.
Tryngolza has met endpoints in a moderate hypertriglyceridemia trial. Positive results in severe disease in Q3 could allow for a filing for a broader patient population than its currently approved indication of familial chylomicronemia syndrome.
A federal court jury found Amgen liable for violating antitrust laws in allegedly preventing Praluent from competing against Repatha.
The company has established the efficacy of its biologic Saphenlo in systemic lupus erythematosus but is now investing across modalities to stay ahead of rivals.
The first Phase III data for the CD38-targeting antibody is expected in 2027 in antibody-mediated rejection in kidney transplant patients, followed by other indications.
Novo Nordisk will partner with privately held Deep Apple to study a novel, non-incretin target that could be better suited than GLP-1s for long-term obesity treatment.
