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Merck’s cancer drug Keytruda has received its second FDA breakthrough therapy designation, this time for advanced non-small cell lung cancer. 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
Singapore would ban all direct-to-consumer advertisements for prescription drugs under a set of proposed advertising rules scheduled to take effect late next year. Read More
Sponsors seeking to enroll patients in studies of treatments for invasive aspergillosis may use the presence of the molecule galactomannan as a probable indicator of the infection, under an FDA program to qualify biomarkers used in drug development. Read More
European Medicines Agency evaluators have recommended labeling updates for Roche’s rare lung disease therapy Esbriet to include information on the drug’s mortality benefit. 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