Pacira BioSciences, Inc.
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Latest From Pacira BioSciences, Inc.
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.
Bristol makes its own deal with Celgene ally Dragonfly, while Gilead ends virology partnerships with Durect and Precision BioSciences.
Four new pain drug formulations are heading to advisory committees in January. The meetings will also feature new FDA leadership in the pain/addiction review division following the retirement of Sharon Hertz.
A Milbank Quarterly study and a Pink Sheet analysis show that disagreement between the US FDA and its advisory committee meetings doesn't happen often; it is even rarer for the agency to approve a drug against the advice from a panel.
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