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The FDA handed Gilead Sciences an eight-observation Form 483 for an array of production issues, including poor manufacturing instructions and processing procedures. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More
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
A Delaware state judge dismissed with prejudice a decade-old lawsuit filed by six New York Teamsters organizations against AstraZeneca alleging consumer fraud over marketing of the heartburn drug Nexium, saying the purchasers had no evidence they’d been harmed. 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The European Medicines Agency has issued draft guidance on the manufacture of finished dosage forms, clarifying what information drugmakers should include in the quality section of the common technical document that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