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Oversight of the EU’s medicines policy will remain under the health directorate, in an about face from plans, announced in September, to shift responsibility to the industry directorate. Read More
The European Medicines Agency is expanding its public database for reporting suspected adverse drug reactions, adding roughly 1,700 additional products to the site. 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, in an effort to speed approvals. Read More
The Justice Department has launched a probe into potential anticompetitive practices of the generic drug industry, adding more scrutiny to generic drug pricing that already is under investigation by Congress. Read More
European drug safety officials last week recommended lower dosing levels on Amgen’s angina drug Procoralan to lessen risks of heart problems, including heart attacks and excessively low heart rates. Read More
Merck’s effort to expand its footprint in the lucrative hepatitis C market stumbled, with an experimental four-week, triple-therapy regimen proving largely ineffective. Read More
The FDA wants to know how differing levels of exposure to a drug advertisement affect a person’s perception of a product’s risks and benefits. Read More
A New York federal judge has tossed out a lawsuit alleging Eli Lilly misled the public over withdrawal symptoms linked to its antidepressant Cymbalta. Read More
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.
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