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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
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
The FDA has rejected Teva’s seventh citizen petition calling for the agency to boost its scrutiny of any ANDA seeking to make a generic version of the Israeli firm’s blockbuster multiple sclerosis drug Copaxone. 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
The European Medicines Agency last week approved Boehringer Ingelheim’s lung cancer drug Vargatef for treating non-small cell lung adenocarcinomas. 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