Medco Research BiDil (hydralazine/isosorbide dinitrate) not recommended for approval -- FDA committee.
MEDCO RESEARCH CONSIDERING WHETHER TO CONTINUE BIDIL DEVELOPMENT following an unfavorable review by FDA's Cardiovascular & Renal Drugs Advisory Committee at its Feb. 27 meeting. The committee voted 9-3 against recommending approval of the hydralazine/isosorbide dinitrate combination therapy for use in the treatment of congestive heart failure. Following the meeting, the company said that "our plans for BiDil will certainly depend upon whether we believe the specific concerns of the committee and the division are surmountable at a reasonable continued investment by the company."
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