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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
Amarin has received more bad news from the FDA, which granted its prescription fish oil pill just three years of exclusivity instead of five — a decision limiting market power for the drug as it struggles to win an expanded indication. 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
Sponsors should use Extensible Markup Language (XML), not Standard Generalized Markup Language (SGML) when transmitting reports about patient reactions in clinical trials, under an FDA final guidance adopted Friday. Read More
In a decision that expands Sovaldi’s market dominance, the European Medicines Agency (EMA) Friday approved compassionate use of the Gilead drug with ledipasvir to treat patients with hepatitis C genotype 1. Read More
The FDA is proposing to extend new chemical entity (NCE) market exclusivity for certain fixed-dose combination (FDC) drugs from three to five years, bowing to industry and congressional demands that more incentives are needed to pursue the costly products. Read More
After operating its OTC drug review process largely unchanged for 40 years, the FDA has concluded the process needs an overhaul to address long-standing problems. Read More