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A federal judge has finalized an agreement by Pfizer to pay $325 million to settle claims it marketed off-label uses of its epilepsy drug Neurontin. Read More
European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency. Read More
A key Senate health panel will consider a bipartisan bill to hasten the development of Ebola drugs by including the disease under a lucrative voucher program. Read More
The European Medicines Agency has released an online tool designed to help manufacturers report and edit information on their marketed products, as required under the 2010 pharmacovigilance law. Read More
The Scottish Medicines Consortium has approved five new medicines for reimbursement in Scotland, including treatments for cancer, hepatitis C and diabetes. Read More
The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More
The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. 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