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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
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More
Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More