In Brief: FDA Oncologic Drugs Advisory Committee
FDA Oncologic Drugs Advisory Committee: Will review Pharmacia & Upjohn's Camptosar (irinotecan) injection (NDA 20-571) June 13 for metastatic carcinoma of the colon where disease has recurred or progressed following 5FU-based therapy. The committee also is slated to review Ciba-Geigy's Aredia (amidronate disodium) injection (NDA 20-036/S-011) for use in conjunction with standard antineoplastic therapy for osteolytic bone metastases. Guilford's Gliadel (carmustine) wafer (NDA 20-637), an adjunct to brain surgery to prolong survival in patients with malignant glioma, will be reviewed June 14. The meetings will begin at 8:30 a.m. each day at the Gaithersburg, Md. Holiday Inn...
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