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Boehringer Ingelheim (BI) will spend $650 million to settle approximately 4,000 state and federal lawsuits alleging the drugmaker didn’t do enough to warn patients about the hazards of its blockbuster blood thinner Pradaxa. Read More
The FDA wants to know what effect distractions such as moving visuals and music may have on patients’ retention of risk information in direct-to-consumer drug advertisements. Read More
GlaxoSmithKline is facing another bribery probe, this time from a UK watchdog that plans to investigate the drugmaker’s business practices around the world. Read More
Drugmakers should evaluate potential names for new drugs and weed out candidates that include elements such as medical abbreviations, inactive ingredients and partial lists of active ingredients, the FDA says. Read More
Novartis wants the FDA to back off plans that would require drugmakers to include details of clinical trials data in labeling for drugs brought to market under accelerated approval pathways. Read More
Both sides in a patent lawsuit involving the drug Suprep are asking a federal appeals court to reconsider its opinion in the case, saying the court set a dangerous precedent for future Hatch-Waxman patent suits because it recognized infringement for unapproved uses and clouds the definition of “patient” when it comes to the patent claim. Read More
The FDA is moving to withdraw ANDAs for four generic versions of the laxative MiraLAX, nearly six years after the agency issued a notice of opportunity for a hearing (NOOH) threatening to take away the marketing clearance because the reference product had turned OTC while the generics remained prescription-based. Read More
The FDA wants vaccinemakers to begin making adverse events reports electronically, and is launching a pilot study to assess whether its Adverse Event Reporting System is adequate for vaccine reports. Read More