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Manufacturers that adapt existing drugs and biologics to treat rare diseases could receive an additional six months of market exclusivity for the original indication under a new bipartisan House bill. 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 FDA has proposed criteria for how an ANDA can receive an expedited review under the “first generic” review prioritization category, a move the agency hopes will ease industry confusion over the generic drug incentive. 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
In a temporary win for generics manufacturers, the FDA says it will delay its controversial generic drug labeling rule by nine months while it reviews 119 comments it received about the measure. Read More
The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers. 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 FDA has approved a new indication for Sanofi’s tuberculosis drug Priftin in combination with isoniazid to treat latent tuberculosis infection (LTBI). 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 UK lags far behind other industrialized countries in providing patients access to the latest medicines, a situation that is caused by overly zealous national and local healthcare funding schemes, asserts a new report from a British pharmaceutical trade group. Read More