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The FDA is expanding the types of documents that drugmakers can distribute to physicians that discuss off-label drug uses, loosening its limits on clinical practice guidelines (CPGs) and medical textbooks. Read More
Endo Pharmaceuticals has entered into a five-year corporate integrity agreement with HHS to resolve marketing violations surrounding the Lidoderm patch, a popular painkiller. Read More
New authorities granted to the FDA in 2012 that stiffened penalties for drug counterfeiters are failing to curb the problem of fake drugs because they do not apply to distributors of counterfeits. Read More
The FDA is proposing that physicians be allowed to perform fecal matter transplants (FMT) in limited circumstances without an investigational new drug (IND) application, provided the physician or their patient knows the donor. Read More
UK regulators recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 compared to 2012, with the majority of complaints coming from companies complaining about their competitors. Read More
Preliminary data from a late-stage trial of Eli Lilly’s type 2 diabetes drug dulaglutide positions the candidate as a major contender in the increasingly competitive drug class known as GLP-1. Read More
With analysts predicting skyrocketing sales for Gilead Sciences’ hepatitis C treatment Sovaldi, AbbVie has filed a patent infringement suit against Gilead in a bid to ground the drug. Read More
India’s Ministry of Health and Family Welfare on Friday began releasing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial, with the first wave of published data focusing on payouts for trial-related deaths between 2010 and 2013. Read More
Endo Pharmaceuticals, as part of a $192.7 million settlement, has agreed to enter into a five-year corporate integrity agreement (CIA) with HHS to resolve marketing violations surrounding its painkiller Lidoderm. Read More
Republican House members introduce legislation to combat prescription drug abuse through partnerships between industry, retail and government. Read More
The FDA plans to tell drugmakers by the end of November how they should exchange data with supply chain partners to satisfy new federal track-and-trace requirements. Read More