The U.S. Supreme Court cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines.
Influential proxy firm ISS advised voting against generic drugmaker Mylan NV’s incumbent board of directors, saying it should be held responsible for reputational damage over drug-pricing issues and the chairman’s pay package.
Gilead Sciences Inc. today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults.
Coherus BioSciences Inc. said the U.S. FDA denied the approval of its biosimilar for Amgen Inc.’s blockbuster treatment Neulasta, which fights infections in cancer patients.
Shares of Regulus were down more than 23 percent after pharma giant AstraZeneca terminated its involvement with the company’s clinical development program for the treatment of non-alcoholic steatohepatitis (NASH).
France’s Sanofi and partner Regeneron Pharmaceuticals said their anti-cholesterol drug Praluent recorded positive results in its first dedicated studies involving patients with diabetes and high cholesterol.
Merck in partnership with Pfizer Inc. announced that two Phase 3 studies of ertugliflozin met their primary endpoints.
Purohit Navigation – a full-service, independent, healthcare communications and advertising agency – announced that the company has expanded its already seasoned staff to serve a growing client base.
Japan has dropped proposals on price cuts for prescription drugs aimed at boosting the use of generic drugs, underscoring the government’s struggle to rein in bulging social security costs for a rapidly aging nation.
Astellas Pharma Inc. and Pfizer Inc. announced today the amendment of the protocol for the registrational PROSPER trial. The multi-national, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of XTANDI (enzalutamide) in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer.