The U.S. Court of Appeals for the First Circuit upheld a $142 million racketeering verdict against Pfizer and revived two similar civil cases filed by third-party payers asserting violations of the Racketeer Influenced and Corrupt Organizations (RICO) Act based on the company's off-label promotion of epilepsy drug Neurontin (gabapentin).

The FDA released a draft guidance to help biosimilar sponsors request and be better prepared for formal meetings with the agency about product development. The FDA expects its review staff will be participating in many meetings with sponsors seeking guidance on the development and review of biosimilars.