FUJISAWA PLANT CLEARED TO MANUFACTURE ADENOSCAN
FUJISAWA PLANT CLEARED TO MANUFACTURE ADENOSCAN but approval may be delayed pending the signing of a short-term manufacturing agreement with Medco Research, the holder of the Adenoscan (adenosine) NDA. Medco announced on May 11 that it had "received notification from FDA that Fujisawa's Grand Island [N.Y.] manufacturing facility is now qualified" to produce the cardiovascular stress test agent that will be used as an adjunct to imaging of coronary artery disease and that the company "hopes that an interim manufacturing agreement will be reached with Fujisawa."
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