In Brief: MedImmune's RespiGam
MedImmune's RespiGam: FDA's Blood Products Advisory Committee will review the PLA for RSV-IVIG product in the prevention of serious respiratory syncytial virus on Dec. 15. MedImmune amended its RespiGam PLA in September. The PLA was previously rejected by the committee. The committee also will meet in closed session at 2 p.m. on Dec. 15. On Dec. 14, in the morning the committee will hear FDA updates on Creutzfeldt-Jakob disease and HIV-1 screening, Trypanosoma cruzi testing of blood donors, and a report of an FDA-HRSA contract study of the U.S. tissue procurement distribution system. On the afternoon of Dec. 14, the committee will hear a summary of a workshop on cord blood and peripheral blood hematopoietic stem cell products intended for transfusion. The meeting begins at 8 a.m. on both days in conference rooms D & E of FDA's Parklawn building in Rockville, Md...
You may also be interested in...
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
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth