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Sandoz and Amgen are separately asking the full Federal Circuit Court of Appeals to review a July decision by a three-judge panel on the biosimilar approval pathway, saying the ruling is contrary to Congress’ intent in the Biologics Price Competition and Innovation Act. Read More
Pfizer has released positive topline results of two Phase 3 studies of its meningitis vaccine Trumenba, saying its ability to provoke an immune response and safety data are consistent with the findings that formed the basis for its FDA accelerated approval. Read More
Novartis has agreed to pay up to $1 billion for the rights to autoimmune indications for GlaxoSmithKline’s Arzerra, including multiple sclerosis, following an earlier deal for the drug’s oncology indications. Read More
With more than 80 percent of APIs coming into the U.S. from foreign sites, the FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More
Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance reduced the risk of cardiovascular events in adults with Type 2 diabetes who are at high risk of such events, making it the only glucose-lowering agent to demonstrate this benefit in a dedicated trial. Read More
Valeant Pharmaceuticals wasted no time in signing a deal to acquire Sprout Pharmaceuticals for $1 billion, following Tuesday’s FDA approval of Sprout’s female libido drug, Addyi. Read More