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Mallinckrodt has sued the FDA over its decision last month to revoke the equivalence rating on the company’s generic version of Janssen’s attention deficit hyperactivity disorder drug Concerta. Read More
The FDA’s citizen petition process is overloaded with meritless petitions whose only purpose is to try to delay competition from generic drugs, despite past efforts at reforming it, the agency says. Read More
The recent spike in generic drug prices is not an isolated phenomenon, says a senator who introduced legislation last month that would require generics firms to provide a rebate to Medicaid if their prices rise faster than inflation, something that brandmakers already are required to do. Read More
The FDA is expected to start training investigators next year on how to tell whether a facility’s quality culture is good or poor, a development that lays the groundwork for eventual scrutiny of this new indicator during inspections. Read More
The UK’s healthcare cost watchdog is recommending coverage of Roche’s cancer drug Gazyvaro with chlorambucil for some chronic lymphocytic leukemia patients, reversing its earlier rejection of the combo therapy over concerns with the manufacturer’s clinical- and cost-effectiveness models. Read More
The FDA yesterday finalized the first of four guidances that govern how drugmakers scale up production of a drug once it’s approved, the first revision to the guidances since the late 1990s. Read More
Manufacturers of fixed dose combination products that are less than four years old should confirm with India’s drug pricing authority that the products have been approved and are not deemed prohibited under Indian drug law. Read More
A pan-European health technology assessment body has recommended that EU cost-effectiveness evaluators compare new pharmaceuticals against the most relevant standards of care, in a new framework to harmonize different member states’ individual guidelines on making coverage decisions. Read More
UK healthcare cost evaluators affirmed their earlier coverage recommendation of Alexion’s rare blood disease drug Soliris, but still expressed concerns over the therapy’s high costs. Read More