FDAnews Drug Daily Bulletin

The FDA’s Office of International Programs (OIP) is exploring development of a single, global recall system that would encompass all domestic and international recalls.

Manufacturers withdrawing their drugs from any market in the EU will now have to notify competent authorities of the reason, according to amended pharmacovigilance rules adopted by the Council of the European Union Oct. 4.

Mexican drug regulator Cofepris has doubled its clinical trial protocol review timeline, with approvals coming in six months now instead of three, an expert says.

In 2009, Roche made a public promise to release full clinical trial reports of its antiviral drug oseltamivir (Tamiflu) in response to an investigation by the British Medical Journal and Cochrane collaborators Peter Doshi and Tom Jefferson.

Seattle Genetics announced that the European Commission has granted conditional marketing authorization for Adcetris (brentuximab vedotin).

Swiss drugmaker Novartis said on Wednesday it would spend more than $500 million on a new biotechnology production site in Singapore to support its growing pipeline of biologics.

Biogen Idec has become the latest company to challenge the U.S. Patent and Trademark Office’s calculation of patent term adjustments, arguing in a suit filed in Virginia that the term of its patent on a compound used to treat neuronal dysfunction should be extended by 125 days.

Sunovion Pharmaceuticals said the FDA has accepted its applications to expand the indication of its schizophrenia drug, Latuda (lurasidone), to be used as a treatment for bipolar disorder.

TauRx Therapeutics started enrolling patients in the U.S. for two late-stage clinical trials to test an experimental treatment for mild to moderate Alzheimer’s disease.