Committee Recommends Continuation of Pneumonia Treatment Trial
An independent data monitoring committee has recommended the continuation of the Chiron Corp, Emeryville, Calif, CAPTIVATE study, an ongoing Phase 3 clinical trial of tifacogin for the treatment of patients with severe community-acquired pneumonia. The committee made its recommendation following a planned interim analysis of clinical data from the study. The study data remains blinded to Chiron, and detailed analysis will not be available until the trial has been completed. No safety concerns were identified by the committee, confirming safety assessments conducted when patient enrollment reached 300 and again at 600. “We appreciate the careful analysis conducted by the committee and their assessment of the study data on tifacogin,” says Stephen Dilly, MD, PhD, chief medical officer of Chiron BioPharmaceuticals. “We look forward to a final analysis of the study data.”

Philips Introduces New Sensors
Royal Philips Electronics, Andover, Mass, recently received US Food and Drug Administration clearance for two new single-patient-use Spo2 pulse oximetry sensors used primarily for neonatal patients. These patients frequently have sensitive skin, so the new sensors are designed using soft foam material and special adhesives. “These two new sensors offer clinicians a wider selection of disposable sensors to better address the needs of their smallest patients,” says Jim Polewaczyk, senior director and general manager, medical consumables, Philips Medical Systems.

Sepracor Submits New Drug Application
Sepracor Inc, Marlborough, Mass, has submitted a New Drug Application to the US Food and Drug Administration for arformoterol tartrate inhalation solution, a long-acting ß-agonist formulation for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Arformoterol, a single isomer of formoterol, is the first long-acting bronchodilator to be developed in an inhalation solution for use with a nebulizer. “If approved, arformoterol inhalation solution may provide a meaningful medical benefit,” said Mark H.N. Corrigan, MD, executive vice president of research and development at Sepracor.

Medline Launches Respiratory Division
Medline, Mundelein, Ill, has launched a new respiratory division dedicated to meeting the growing demand for respiratory products and services. “Over the past 10 years we’ve experienced tremendous growth in respiratory sales, averaging close to 30% per year,” said Dennis Cook, Medline respiratory division president. “There are more than 40 million people in the United States with some type of respiratory ailment, ranging from asthma to chronic obstructive pulmonary disease (COPD) to obstructive sleep apnea to pneumonia. We want to provide our customers with the best service, so we really needed to invest in this market.” Medline’s respiratory group will include a team of engineers working on the development of a series of new products. The new division will offer continuing education, and its staff will include several clinicians serving as product managers. The clinical expertise will help both Medline engineers and customers better understand this complex product area. “We’re dealing with products that can literally mean the difference between life and death, so it is imperative that we have the expertise in house to make sure we are providing our customers with the technical know-how to provide better care for their patients,” said Cook.

Invacare Wins Award for HomeFill Marketing Program
Invacare Corp, Elyria, Ohio, was recognized recently at the 2005 MM&M (Medical Marketing & Media) Awards for its successful HomeFill™ II cooperative marketing program. MM&M recognized the program in the category “Best Use of Direct Marketing to Consumers,” which honors and promotes the role creative ideas play in effective direct communications. Invacare’s program was one of 474 entries, which included submissions from companies such as Johnson & Johnson and Pfizer.