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Actavis plans to immediately relaunch its generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules, following a federal appeals court decision upholding a lower court ruling that invalidated the brandmaker’s patent on the drug. Read More
The European Medicines Agency has confirmed plans to halt sales of 700 drug forms and strengths authorized based on clinical studies performed by Hyderabad, India-based GVK Biosciences. Read More
A federal appeals court Friday affirmed a lower court order preventing Actavis from replacing an older formulation of Namenda ahead of generic versions of the Alzheimer’s drug hitting the market in July. Read More
The FDA is hoping that a study of spousal communication related to direct-to-consumer prescription drug advertising will help it make better recommendations for these ads. Read More
Johnson & Johnson will be liable for unlimited punitive damages in a bellwether trial next month alleging that Extra Strength Tylenol triggered acute liver failure leading to a woman’s death, under a federal court ruling. Read More
The House Energy & Commerce Committee released a new version of the 21st Century Cures Act that scales back the rare pediatric disease priority review voucher program. Read More
The U.S. Supreme Court has rejected the third and final request for review of a Pennsylvania state court ruling that would allow individuals to sue generics makers for failing to update warnings on drug labels. Read More