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Drugmakers are split on whether the FDA should establish a program to reserve proprietary product names, with some calling for a new fee-based system and others recommending ways to improve the current process that has derailed applications with late-stage name rejections. Read More
Generic drugmakers frequently miscalculate the amount of user fees they owe the FDA, a situation that has landed many companies on the GDUFA arrears list, the head of the FDA's user fee management division said. Read More
A federal judge slashed the $9 billion jury verdict levied against Takeda and Eli Lilly to $36.8 million in a case that alleged the companies misled patients about cancer risks of the diabetes drug Actos. Read More
Teva and U.S. subsidiary Cephalon want to block the City of Chicago from publically releasing a 2007 opioid marketing plan that the city obtained during its investigation into Cephalon and other drugmakers over alleged deceptive marketing practices. Read More
Novartis has sold its influenza vaccine business to Australian drugmaker CSL Limited for $275 million, the latest effort by Novartis to shift away from vaccines and focus on other types of products. Read More
European drugmakers say they support recent EU efforts to fight counterfeiting, but would like to see some changes to a provision that aims to catch fake products as they move across member-state borders. Read More