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Lilly said the drug will be available in the week of Aug.15, before the anticipated depletion of the U.S. government’s currently available supply. Read More
Janet Woodcock, principal deputy FDA commissioner, made clear the dire situation her agency will be in if user fees aren’t rapidly reauthorized and the FDA doesn’t receive new money from Congress to update its flagging IT infrastructure. Read More
A U.S. District Court in Illinois has found that Eli Lilly shortchanged Medicaid’s drug rebate program in 26 states and must pay a $61 million penalty for violating federal and state false claims acts. Read More
The companies argued that there was no scientific evidence available at the time of the initial labeling of the drugs to justify including such warnings. Read More
A U.S. appeals court panel has said no to resurrecting a 2019 lawsuit alleging that AbbVie broke antitrust laws by using a “patent thicket” to cover its blockbuster monoclonal antibody Humira from copycat drugs coming to market, thus exploiting the patent system. Read More
Generics makers will soon have the option to submit expedited safety reports electronically to the FDA Adverse Event Reporting System (FAERS), according to a new draft guidance that provides instructions for electronic transmission. Read More
More than 100 West Virginia cities and counties have reached a $400 million settlement with drug distributors McKesson, AmerisourceBergen and Cardinal Health, resolving allegations that the companies recklessly oversupplied West Virginia residents with opioids. Read More