BioCryst Pharmaceuticals, Inc.
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Latest From BioCryst Pharmaceuticals, Inc.
The company presented 18-month data at a conference that it thinks will support strong uptake. European regulators required the 18-month data for filing; an FDA decision based on 9-month data is expected in April.
Mark McClellan discusses whether CMS’s pending final version of the Medicare national coverage determination on Alzheimer’s drugs might change from the draft and whether the decision should be viewed as a precedent for drugs granted accelerated approvals.
Pink Sheet reporters and editors discuss how the hearings for the withdrawal of Avastin’s accelerated approval in breast cancer could inform the same process for Makena, Robert Califf’s view that public trust in the agency will be rebuilt, and a request to increase the dispensing fees associated with COVID-19 treatments Paxlovid and molnupiravir.
The rate at which investigational drugs were accepted onto the European Medicines Agency’s priority medicines scheme dropped in 2021. Meanwhile, more much-needed treatments that had been developed under the scheme went on to win EU marketing approval.
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