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The South Carolina Supreme Court slashed nearly $12 million from the penalty imposed against Johnson & Johnson’s Janssen subsidiary for allegedly hiding risks associated with the antipsychotic Risperdal. Read More
After considering a slew of proposed amendments to the 21st Century Cures Act, the House Rules Committee agreed on only one that affects drugmakers: a provision requiring the Centers for Disease Control and Prevention to conduct a study to determine how additional Medicare payments for new antimicrobial drugs are affecting the development of drug resistance. Read More
CDER plans to spread drug company inspections across three of its offices — the Office of Regulatory Affairs, Office of Pharmaceutical Quality and Office of Compliance — rather than conduct all inspections through OPQ, center officials said Wednesday. Read More
The second former Gallant Pharma International employee in as many days has been barred by the FDA from doing business in the U.S., after she was convicted of a felony for selling counterfeit drugs. Read More
The agency is revoking requirements regarding inactivated influenza vaccine, allergenic products and the detection of extraneous toxic contaminants. Read More
The FDA has permanently barred an Arlington, Va., distributor from doing business in the U.S. after he was convicted of two felonies for selling counterfeit products. Read More
Eli Lilly’s lung cancer drug necitumumab improved overall survival when used with two combined chemotherapies, but caused a small uptick in sudden deaths, the FDA says in a preliminary review issued Tuesday. Read More