Drug Industry Daily

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The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says.

The FDA has approved Pfizer’s Xeljanz as a second-line treatment for adults with moderately to severely active rheumatoid arthritis (RA) who didn’t respond to or cannot take methotrexate.

Novo Nordisk’s ultra-long acting insulin candidates Tresiba and Ryzodeg appear to be associated with an increase in cardiovascular risk, FDA reviewers said in briefing documents leading up to a Thursday advisory panel meeting.

The FDA has hit International Laboratories Canada with a warning letter for good manufacturing practice (GMP) violations related to supplier qualification and the company’s quality control unit.

Novartis’ Cushing’s disease drug Signifor has proved its value in normalizing patients’ urinary free cortisol levels, FDA reviewers say before an advisory panel meeting on the drug.