Advancis, FDA agree on guidelines
Advancis Pharmaceutical Corp. and the Food and Drug Administration have agreed upon guidelines for the resubmission of a drug application seeking approval of Amoxicillin PULSYS, a time-released antibiotic. An earlier submission was rejected because Advancis did not include enough information about its plans for commercial manufacturing. The delay has set back launch plans for the drug to late February 2008.
AAI wins pact worth $14.9 million
AAI Services Corp., a subsidiary of Hunt Valley-based United Industrial Corp., won a $14.9 million contract from the Air Force to develop an aircraft engine maintenance trainer for the C-17 Globemaster III. The trainer is scheduled to be delivered to Hickam Air Force Base, Hawaii, in October 2010. The work will be performed by AAI Services in Charleston, S.C.
Visicu closes at all-time low
Shares in Visicu Inc., the Baltimore company that develops monitoring systems for intensive care patients, tumbled 75 cents, or 9.6 percent, yesterday in the wake of a continuing patent dispute with a competitor. Shares closed at $7.03, an all-time low for Visicu, which began public trading last April. On Tuesday, the competitor, Massachusetts-based iMDsoft, said Visicu had narrowed its patent claims. Visicu executives disputed iMDsoft's account, saying their patent claims had been clarified.
M. William Salganik
Kelly picked to head CareFirst board
CareFirst of Maryland said yesterday that its board of directors had elected Michael J. Kelly as chairman of the board of CareFirst of Maryland, replacing John M. Colmers, who resigned when he became state health secretary. New members named to the board were Barbara Blount Armstrong, chief operating officer of Associated Black Charities; Dr. James A. D'Orta, a physician and CEO of International Medical Consulting Inc.; Joseph G. Hall, a vice president of Goldman Sachs; Richard N. Kramer, chief operating officer of PinnacleCare Inc.; Margaret Scott Schiff, vice president for finance and human resources of The Washington Post; and James J. Xinis, CEO of Calvert Memorial Hospital.
M. William Salganik
USW leader resting after heart attack
United Steelworkers Local 9477 President John Cirri has temporarily handed the reins to Vice President John Hough while he recovers from a heart attack suffered Saturday. Hough said Cirri is still very much a part of negotiations surrounding the sale of the Sparrows Point steel mill.