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Senior European Medicines Agency (EMA) officials are cautioning their peers that when it comes to making regulatory decisions, high levels of risk aversion may do more harm than good. Read More
The Government Accountability Office (GAO) has been asked by a bipartisan group of six senators to analyze and report on current federal activities impacting regenerative medicines. Read More
GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
Drugmakers should establish a company task force of upper management and quality personnel to prevent drug shortages, according to new good practice guidelines developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Read More
The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
A multidistrict mass tort suit filed July 1 in Illinois accuses Bristol-Myers Squibb and Sanofi of recklessly promoting the benefits of their blockbuster blood-thinner Plavix, despite knowing it was “defectively designed, inadequately tested, dangerous to human health, and lacked proper warnings as to dangers associated with its use.” Read More