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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
The FDA is clarifying when drugmakers should seek formal and informal presubmission meetings with the Office of Orphan Products Development, in an effort to save time and resources. Read More
A former Warner Chilcott district sales manager pleaded guilty Tuesday to conspiring to deceive Medicare and private health insurers so they would pay for the firm’s osteoporosis drugs, Actonel and Atelvia. 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
Amphastar is facing increasing pressure to cut the high cost of naloxone, this time in a letter from Rep. Elijah Cummings to Maryland officials urging them to negotiate a lower price for the opioid overdose reversal drug. 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
Samsung Bioepis’ investigational Humira biosimilar, SB5, demonstrated equivalence to the reference product in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy in a pivotal Phase 3 clinical trial, the South Korean drugmaker said Wednesday. Read More
The FDA Tuesday approved Novartis’ heart failure drug Entresto, which had received priority review and fast track designations to expedite therapies for life-threatening conditions and unmet medical needs. Read More