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Increasing data is driving collaboration among drugmakers, insurers, health systems and technology firms to deliver cost-effective and improved treatments to patients, a just-released PwC report concludes. Read More
The FDA’s Oncologic Drugs Advisory Committee largely appeared to agree that Eli Lilly’s lung cancer drug necitumumab offers some late-stage lung cancer patients increased survival time, despite an increased risk of adverse events, but didn’t vote on whether to recommend the product for approval. Read More
Teva said Wednesday that it has launched a generic version of Janssen Pharmaceutical’s migraine drug Axert in the U.S., following receipt of FDA approval. Read More
The European Medicines Agency has issued draft guidance on the manufacture of finished dosage forms, clarifying what information drugmakers should include in the quality section of the common technical document that is part of a premarket application. Read More
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