Two-thirds of the way through fiscal year 2017, the FDA has received at least 877 ANDAs, passing fiscal 2016’s total of 852 and beating fiscal 2015’s total by more than…

The FDA is proposing an experimental study to examine the effects of risk disclosures and fine print in direct-to-consumer drug advertising. Source: Drug Industry Daily

The European Medicines Agency has decided to postpone the implementation of its Clinical Trials Regulation from October of next year to 2019 at the earliest, due to technical difficulties. Source:…

A trio of individual pharmaceutical recalls swept through the industry last week, spotlighting a variety of formulation and quality control issues at major drugmakers. Source: Drug Industry Daily

Nevada’s landmark plan requiring insulin manufacturers to disclose price information was signed into law last week, establishing a more targeted strategy compared to the broader price transparency legislation currently being…

Beacon Prescriptions, a compounding pharmacy in Southington, Conn., was warned by the FDA for unsanitary conditions and other federal violations, according to a letter sent earlier this month. Source: Drug…

A federal district judge shut down drugmaker Stratus Pharmaceuticals in Florida and distributor Sonar Products of New Jersey with a permanent injunction Thursday. Source: Drug Industry Daily

The U.K. is planning to move Roche’s Kadcyla (trastuzumab emtansine) into the NHS’s routine funding programs later this summer, following guidance from the National Institute for Health and Care Excellence…

The PTO’s Patent Trial and Appeal Board said it will review patents covering the blockbuster erectile dysfunction drug Cialis and a widely used pneumonia vaccine, Prevnar 13, granting petitions from…

An appeals court reinstated a wrongful-death lawsuit against Teva Pharmaceuticals, saying the lower court improperly ignored witnesses’ expertise and sent it back to a California federal court for a new…