Filgotinib: First Approval

Durvalumab: First Global Approval

Intravenous durvalumab (Imfinzi™; AstraZeneca) is a fully human monoclonal antibody that blocks programmed cell death ligand-1 binding to its receptors (PD-1 and CD80), resulting in enhanced T-cell responses against cancer cells. The US FDA has granted durvalumab accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progress...

Approval of the first biosimilar antibodies in Europe

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for two biosimilar infliximab products (Celltrion's Remsima® and Hospira's Inflectra®), and recommended that they be approved for marketing in the European Union (EU). The European Commission's decision ...

Filgotinib for Crohn's disease-expanding treatment options.

Daptomycin: a review 4 years after first approval.

Daptomycin is the first approved member of a new class of antibiotics, namely the cyclic lipopeptides. Daptomycin has rapid bactericidal activity against Gram-positive pathogens. It acts by penetrating into the bacterial cell wall with consecutive formation of pores, loss of electrical membrane potential and inhibition of peptidoglycan synthesis. As the mode of action of daptomycin is 'concentr...

Is Approval Voting Optimal Given Approval Votes?

Some crowdsourcing platforms ask workers to express their opinions by approving a set of k good alternatives. It seems that the only reasonable way to aggregate these k-approval votes is the approval voting rule, which simply counts the number of times each alternative was approved. We challenge this assertion by proposing a probabilistic framework of noisy voting, and asking whether approval v...