FDA's Oncologic Drug Products Advisory Committee
Will consider on July 1 Bristol-Myers Squibb's teniposide for multiple indications for childhood acute lymphocytic leukemia, BMS' Paraplatin (carboplatin) as a first-line combination chemotherapy in stage III and IV ovarian cancer, and Lederle's Isovorin (1-leucovorin) for methotrexate overdose. On July 2, the panel will review Parke-Davis' Oncopent (pentostatin) for hairy cell leukemia refractory to alfa interferon. The committee will also review the National Surgical Adjuvant Breast and Bowel Project's tamoxifen (ICI's Nolvadex) breast cancer prevention protocol. The meeting will be held in the conference rooms D&E of FDA's Parklawn Building.
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