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New York’s attorney general has filed what may be a first-of-its-kind antitrust lawsuit against Actavis and subsidiary Forest Laboratories for seeking to switch patients on its Alzheimer’s drug Namenda to a newer formulation with longer lasting patents in order to stave off generic competition. Read More
Indian pharmaceutical authorities have collected only $62 million, or roughly 9 percent, of the $688 million they say drugmakers owe in fines for the overcharging of drugs. Read More
The FDA warned an active pharmaceutical ingredient manufacturer for not paying its facility user fees. However, the company says it hasn’t made APIs since 2008. Read More
Generic drugmakers submitting ANDAs that indicate impurities in proposed products that exceed established thresholds must provide detailed justification to avoid having the application rejected, the FDA said. Read More
A new report from the Italian Medicines Agency says that 10 percent of Italian hospitals register pharmaceutical thefts, a problem that the European pharmaceutical industry hopes to end with a pan-European verification system set to go live by 2017. Read More
The European Medicines Agency has issued revised guidelines that aim to ease overly burdensome postmarket monitoring and reporting requirements under the EU’s 2010 good pharmacovigilance practices (GVP) regulations. Read More
A federal judge has tossed out all claims brought against Pfizer and Ranbaxy by retailers and distributors in a larger lawsuit that alleges the two companies colluded to delay a generic version of Pfizer’s blockbuster cholesterol drug Lipitor. Read More
Seven generics firms are set to begin distributing licensed versions of Gilead’s blockbuster hepatitis C drug Sovaldi in 91 developing countries, as part of a deal to expand access to the expensive therapy. Read More