Abbott bows out of Flutiform pact

Following the FDA's decision in June to require more clinical trials of SkyePharma's asthma drug Flutiform, partner Abbott has returned U.S. marketing rights to the British drugmaker. Under an agreement, there are no material payments due by either party on termination. Earlier this year, the FDA said 'substantive' issues would need to be addressed before Flutiform app could be approved. And this effort would require significant clinical work, as the agency wanted additional data...

SkyePharma shares blitzed after FDA spurns Flutiform app

SkyePharma's long-troubled attempt to gain FDA approval for the asthma drug Flutiform officially hit a brick wall today, with the agency demanding what the developer termed significant new clinical work before it could OK the therapy. "From the discussions held at the meeting it is apparent that the FDA's requirements for approving Flutiform have changed materially during the course of the development program and meeting these requirements would involve significant additional work, including a...