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Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development. Read More
European Medicines Agency evaluators have recommended labeling updates for Roche’s rare lung disease therapy Esbriet to include information on the drug’s mortality benefit. Read More
European drugmakers praised a plan to move medicines regulation from a tripartite of directorates led by health and consumers to a single directorate, industry, saying it will reduce organizational silos. Read More
To avert drug shortages, Health Canada has partially lifted an import ban on products from three Indian manufacturing facilities that were barred from doing business in the country due to quality violations. Read More
The Australian government has authorized an independent review of the country’s drug approval process to remove or streamline areas of unnecessary, duplicative or ineffective drug regulations. Read More
European drugmakers say they support recent EU efforts to fight counterfeiting, but would like to see some changes to a provision that aims to catch fake products as they move across member-state borders. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval following its recent meeting, including products to treat intolerance to sunlight, ovarian cancer, oestrogen deficiency and hemophilia B. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a corrective or preventive action (CAPA) investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
The UK’s cost-effectiveness watchdog has recommended coverage of Bayer’s blood thinner Xarelto for preventing blood clots in people who have had a heart attack based on evidence the drug can decrease the cardiovascular risk by up to 20 percent. Read More
European regulators say they are prepared to start a continual assessment of data on experimental Ebola treatments as soon as they receive each submission. Read More