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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
A federal judge Tuesday overturned Massachusetts’ ban of Zogenix’s controversial painkiller Zohydro ER, saying the state overstepped its authority. Read More
Boehringer Ingelheim and Eli Lilly said Monday that the FDA has accepted their NDA for a first-in-kind drug combination to treat type 2 diabetes. Read More
GlaxoSmithKline said Monday it is under investigation in Poland for allegedly bribing doctors to promote the asthma drug Seretide (fluticasone propionate/salmeterol xinafoate). Read More
Drugmakers want the FDA to soften language in its first guidance on social media marketing that would make companies responsible for third-party content. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
EU member states will be able to purchase pandemic vaccines and other medical countermeasures as a group, under a new procurement scheme adopted Thursday. Read More