We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The City of Chicago has sued five manufacturers of opioid painkillers, alleging the firms improperly marketed the addictive drugs for chronic, non-cancer-related pain management, a practice that elevated the city’s addiction rate and resulted in millions of dollars of unnecessary payments. Read More
The FDA has added three new pathogens to the list of infectious agents that drugmakers can target to receive accelerated approval and extended market exclusivity under the agency’s program aimed at antibiotic-resistant infections. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant have turned up quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More
Drugmakers conducting animal trials to support development of biological and chemical weapon counter-measures should control for the animals’ age, health, weight and physical environment when designing study protocols, says a new draft guidance implementing the FDA’s Animal Efficacy Rule. Read More
Alexion is pulling more of its flagship product Soliris from the market due to visible particles that arose from a manufacturing problem, its third recall in less than a year. Read More
Pfizer has agreed to pay $325 million to private insurers to settle a decade-old lawsuit alleging the drug giant illegally marketed the epilepsy drug Neurontin for off-label purposes. 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
The FDA is developing mathematical algorithms that will compare generic drugs to their branded counterparts, according to an agency grant announcement. Read More