PEG-Intron/Ribavirin Pediatric Responder Studies Address Safety Concerns
PEG-Intron/ribavirin combination studies in children with hepatitis C should consider enrolling only early responders to therapy to minimize adverse events, committee member Robert Fink, MD, Children's National Medical Center, suggested at an April 23 meeting of FDA's Anti-Infective Drugs Advisory Committee/Pediatric Subcommittee.
You may also be interested in...
FDA plans to require longer follow-up for pediatric studies, CDER Associate Director of Pediatrics Dianne Murphy, MD, told the FDA Anti-Infective Drugs Advisory Committee/Pediatric Subcommittee April 23.
Schering-Plough will study whether the hepatitis C treatment PEG-Intron produces lower response rates in African American patients following approval of the pegylated interferon.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011