Resolving the conflict between feasibility and relevance

Monday, May 15, 2017

Multi-disciplinary teams tasked with the design of phase III clinical trials face a series of challenges. These include: determining the number of subjects required for statistically meaningful results, the time to complete the trial, budget and regulatory hurdles and guideline implications of the trial design.

[Read More]

Johnson & Johnson, Janssen Pharmaceuticals, Scios finalize Risperdal settlements, will pay $2 billion

Monday, November 4, 2013

Johnson & Johnson and its subsidiaries, Janssen Pharmaceuticals and Scios have finalized previously disclosed settlement agreements with the U.S. Department of Justice (DOJ) and 45 states resolving federal investigations and state Medicaid claims related to past promotional practices of Risperdal (risperidone) from 1999 through 2005, and other matters. The resolution includes total settlement amounts of approximately $2 billion to the federal government and state Medicaid programs, an amount previously accrued, and no additional charge to the company’s earnings will be recorded in connection with this settlement.

[Read More]