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The Trump administration’s newly negotiated trade deal with Canada and Mexico threatens to keep American drug prices high, two dozen-plus consumer, health, trade and other organizations warned in a letter to the U.S. Trade Representative. The 29 groups — including the Association for Accessible Medicines (AAM) and the AARP — claim some provisions in the proposed NAFTA overhaul are inconsistent with U.S. law. Read More
The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. Read More
Two prominent UK drug organizations say they’re “generally supportive” of MHRA’s contingency plans if the UK exits the EU on March 29 without a deal, but expressed concern about orphan drugs and centrally authorized product licenses, among other issues. Read More
The state of Kentucky filed a lawsuit against Teva, alleging the drugmaker’s off-label promotion of two drugs for cancer pain has exacerbated the opioid epidemic. Read More
A Superior Court jury in Hartford, Connecticut found Boehringer Ingelheim not liable for the severe internal bleeding a Pensacola, Florida, man suffered after using the company’s blood thinner Pradaxa. Read More
The U.S. Court of Appeals for the Federal Circuit upheld a 2017 ruling by the Patent Trials and Appeals Board rejecting Forward Pharma’s challenge to Biogen’s Tecfidera patent. Read More
President Trump signed two bills into law barring pharmacy benefit managers and insurers from placing gag clauses in their contracts with pharmacies that prohibit them from alerting consumers to less expensive drug options. Read More
PhRMA released new guidelines on price transparency in advertising in an effort to preempt tough mandatory regulations that would require ads to include featured drugs list prices. Read More
The FDA released new guidance on how researchers can comply with both agency regulations and pending Common Rule revisions that protect human subjects in clinical trials. Read More