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Sponsors of drugs to treat partial onset seizures (POS) in pediatric patients should extend their trials to children as young as two, according to a final guidance the FDA released on Thursday. Read More
Purdue Pharma is prepared to file for bankruptcy by the end of the month if it can’t hammer out an opioid litigation settlement with states and cities across the U.S. Read More
A proposed class action lawsuit in a California federal court claims Assertio Therapeutics and Lupin entered into a pay-for-delay agreement over Assertio’s diabetes drug Glumetza (metformin). Read More
Cancer drugs now account for 27 percent of all new drug approvals in the U.S., up from just four percent in the 1980s — in part because of improved trial designs, novel drug formats and new targets — according to a new study from the Tufts Center for the Study of Drug Development (CSDD). Read More
The FDA has again shot down Mylan and Biocon’s copycat of Sanofi’s Lantus (insulin glargine) with a complete response letter, pending the completion of corrective actions at Biocon’s Malaysian insulin plant. Read More