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An FDA advisory committee voted to recommend approving a formulation of desmopressin for frequent nighttime urination, with some saying it should be approved in a separate indication that had not been explicitly tested in a clinical trial. Read More
Sandoz is asking the FDA not to approve generic versions of GlaxoSmithKline’s Advair Diskus, unless the copycat versions have undergone adequately controlled pharmacokinetic studies. Read More
The National Academy for State Health Policy is proposing 10 measures to reduce drug spending, which include greater transparency on pricing and better enforcement of antitrust laws. Read More
The FDA is proposing annual dues for sponsors of one or more approved ANDAs to guarantee a more predictable stream of funding that will raise revenues for the agency’s generics program starting in fiscal 2018. Read More
Pfizer says it plans to begin sales of a biosimilar version of Remicade in late November, despite Janssen’s appeal of a ruling that invalidated its patent covering the arthritis therapy. Read More