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The FDA now has the power to stop any pharmaceutical import it suspects could be adulterated or misbranded, according to a final rule that implements the agency’s new import authority. 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
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
A Las Vegas jury has found Takeda Pharmaceutical not liable for the bladder cancer of two women who took the Japanese drugmaker’s diabetes drug Actos, marking the firm’s fifth legal victory out of six cases that have gone to trial so far. Read More
Manufacturers that are slow to report overpayments for drugs reimbursed through federal healthcare programs, such as Medicare or Medicaid, could face fines of $10,000 a day, under a proposed regulation — a rule that could cause major headaches for drugmakers trying to sort out complex government billing systems. Read More
A federal judge has tossed out UK-based Reckitt Benckiser Pharmaceuticals’ patent infringement lawsuit against BioDelivery Sciences International over its competing product to Reckitt’s Suboxone, ruling that the court didn’t have jurisdiction because BioDelivery’s drug has yet to be approved. Read More
Manufacturers that are slow to report overpayments for drugs reimbursed through federal healthcare programs, such as Medicare or Medicaid, could face fines of $10,000 a day, under a proposed regulation — a rule that could cause major headaches for drugmakers trying to sort out complex government billing systems. Read More