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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should control for the animals’ age, health, weight and physical environment when designing study protocols, says a new draft guidance implementing the FDA’s Animal Efficacy Rule.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
Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More