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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
India’s final guideline on drug patent applications drops a proposed clause that would have required manufacturers to list names of similar generic products in their filings. 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drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance.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