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The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More
Drugmakers and distributors are asking the FDA to delay strict enforcement of federal track-and-trace requirements, since most companies won’t be able to meet the first deadlines for exchanging transaction data. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More
An FDA task force Tuesday recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
The UK’s Health Research Authority is helping drugmakers do a better job justifying their trial designs and protocol assumptions early on to avoid trial failures due to insufficient information. Read More
Emergent BioSolutions has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military. Read More
Indian Cabinet Secretary Ajit Seth and other top Indian officials today are laying a framework to begin discussions about intellectual property rights with U.S. drugmakers, a number of whom have lost patent protection in India in recent months. Read More
The European Medicines Agency said late last week that additional drugs have been diverted in a still unfolding case of product tampering that began with stolen vials of the cancer drug Herceptin (trastuzumab). Read More