IMMUNOMEDICS CEA-SCAN COLORECTAL CANCER IMAGING AGENT REVIEW DEFERRED BY FDA COMMITTEE; CLINICAL UTILITY MAY BE TOO DIFFICULT TO ASSESS FOR DIAGNOSTICS
The review of Immunomedics' monoclonal antibody-based CEA-Scan PLA for imaging in colorectal cancers was postponed by FDA's Oncologic Drugs Advisory Committee on Oct. 17 until FDA and the sponsor resolve issues concerning analyses and data to be presented to the committee.
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