Biogen Idec is working to address Avonex fill-finish manufacturing problems with the recently approved liquid formulation of the multiple sclerosis therapy
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One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.
A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.
The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
