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European regulators said they will reinstate a good manufacturing practice certification for Ranbaxy’s manufacturing facility in Toansa, India, following an inspection that found the generic drugmaker had addressed reported GMP violations. Read More
British drugmaker GlaxoSmithKline has agreed to pay $105 million to 44 states and the District of Columbia to settle allegations it engaged in deceptive marketing and sales practices on its asthma drug Advair Diskus and antidepressants Wellbutrin and Paxil. Read More
Drugmakers considering names for new products in Europe will have to narrow their options to just two proposed names under a revised guideline from the European Medicines Agency. Read More
Germany-based Sandoz has launched a generic version of Lundbeck’s antidepressant Cipralex in Belgium, France, Germany, Italy, Sweden and Switzerland, the generic firm said. Read More
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should control for the animals’ age, health, weight and physical environment when designing study protocols, says a new draft guidance implementing the FDA’s Animal Efficacy Rule.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