The federal Medicare agency is desperate to woo Part D plans to provide brand name drug coverage in the "donut hole" for 2008 despite the catastrophic failure of enhanced plans so far. Manufacturers should root for CMS to make it happen-but prepare for the fallout if the agency can't.
Michael McCaughan
The donut hole inside the Medicare prescription drug benefit is starting to give the federal government indigestion.
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US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
