Zeftera regulatory update
The European Medicines Agency's CHMP issued a negative opinion on ceftobiprole to treat complicated skin and soft tissue infections (cSSTI). As a result, Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) will return to Basilea full worldwide rights to the compound. The committee was concerned about the reliability of the data for ceftobiprole after EMA inspections showed that the clinical studies had not been conducted in compliance with good clinical practice (GCP). Basilea is reviewing strategic options and will focus on its ongoing arbitration against J&J related to the pharma's handling of clinical studies for the broad spectrum anti-MRSA cephalosporin antibiotic. Basilea expects an arbitration decision by year end (see BioCentury, Aug. 24, 2009 & Jan. 4, 2010). ...