University of N.M., Cerner ink inhaler deal
NEW YORK The University of New Mexico’s Health Sciences Center is developing a dry-powder inhaler with the help of Cerner.
The research, intended for use in both pulmonary and systemic conditions, is intended for use with asthmatics as well as those with chronic obstructive pulmonary disorder and related issues. A reseach agreement provides Cerner with the option for licensing and commercial use of the technology.
Details of the deal were not reported.
Hi-Tech Pharmacal Q3 sales down
AMITYVILLE, N.Y. Hi-Tech Pharmacal has released the results of its third quarter, which ended on Jan. 31.
For the three-month period, the company saw its net sales for generic pharmaceuticals products decrease by 10 percent from $13.8 million during third quarter 2007 to $12.5 million for the same period in 2008.
The healthcare products division, which markets the company’s branded over-the-counter products, had net sales of $2.6 million for the quarter, a decrease of $0.8 million compared with the same period for 2007.
Research and product development costs for the three-month period increased $0.1 million to $1.4 million as compared with $1.3 million for the three-month period ended Jan. 31, 2007, as the company increased expenditures on external projects.
The company experienced a net loss for the period ended Jan. 31, 2008, of $1.5 million compared with net income of $0.7 million in the prior period.
David Seltzer, president and chief executive officer, commented, “The quarter was challenging as we experienced a milder that expected cough-and-cold season, which affected our higher margin prescription products, as well as our OTC brands. Additionally we faced increased competition on selected generic products.”
Seltzer further commented, “We are very upbeat about our generic business due to our recent approval of generic Flonase, and more recently, the approval for the generic alternative to Hycodan. Also, our Midlothian Laboratories division has performed well. To date, the Midlothian division has already launched two new generic prescription products since we announced the acquisition on Dec. 31, 2007. In the healthcare products division, we are excited about the upcoming launch of new and unique products, both in the areas of diabetes management, as well as broader nondiabetes related markets.”
FDA names Woodcock director of CDER
WASHINGTON Food and Drug Administration commissioner Andrew von Eschenbach has named Janet Woodcock as director of the agency’s Center for Drug Evaluation and Research.
In October 2007, while serving as the agency’s deputy commissioner and chief medical officer, where she oversaw scientific and regulatory operations, Woodcock agreed to assume the role of acting director of CDER.
Throughout her career at the FDA, Woodcock has played an integral role in advancing the health of the American public. Under her guidance, the FDA launched the Critical Path Initiative designed to close the gap between basic scientific research and the medical product development process. This initiative called for a collaborative effort to modernize the drug development process and has resulted in several prominent partnerships looking at a wide variety of scientific issues.
“Dr. Woodcock’s exemplary service since October was confirmation of her being ideally suited to lead the center during this crucial period following the passage of the Food and Drug Administration Amendments Act of 2007,” noted von Eschenbach. “The agency is fully committed to implementing the drug safety programs laid out by this act and meeting the goals set under the prescription drug user fee program, which will help ensure that CDER has the additional resources that are needed to conduct these very complex and comprehensive reviews.”