Discussion of a new accelerated dosing regimen for the firm's tissue plasminogen activator (alteplase) has been dropped from the agenda of FDA's Cardiovascular & Renal Drugs Advisory Committee meeting March 25 ("The Pink Sheet" Feb. 28, In Brief). On March 24, the committee will discuss Otsuka America's Arkin (vesnarinone) for the treatment of congestive heart failure. On March 25, the committee will consider Knoll's Rythmol (propafenone) for prophylaxis of paroxysmal supraventricular tachycardia and paroxysmal atrial fibrillation and flutter. The discussion of Rythmol was originally set for the afternoon of March 24. The meeting begins at 9 a.m. both days in 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