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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

FDA panel appointment: Aradigm VP-Clinical & Regulatory Affairs Babatunde Otulana, MD, joins Anesthesiology & Respiratory Therapy Devices Panel for a four-year, non-voting stint as its industry representative. Otulana, who joined Aradigm in 1997, previously served as a medical reviewer at the Center for Drug Evaluation & Research's pulmonary division. Aradigm's AERx pulmonary drug delivery platform recently completed Phase II studies with Novo Nordisk for an inhaled insulin formulation. A Phase III study could begin in early 2002, firm says...

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Financings In Brief

Remon Medical Technologies: Waltham, Mass. concern announces close of oversubscribed $26 mil. Series C financing, which will help expand U.S. presence of its wireless, intra-body communication technology for use in therapeutic products. First-time investors in the financing round include Guidant, Triathlon Medical Ventures and Medica Venture Partners. Guidant previously incorporated Remon's interactive sensor technology into its Ancure abdominal aortic aneurysm endograft (1"The Gray Sheet" Feb. 18, 2002, In Brief). Other major Remon financiers include Polaris Venture Partners, Concord Ventures, Lilly Ventures, KBL Healthcare Ventures and Ofer Hi-Tech. The privately held firm intends to commercialize its communication technology through a mixture of internal efforts and external strategic collaborations. Remon is now conducting clinical trials of its Impressure device, which offers an on-demand, non-invasive way to monitor intra-aneurysm pressures after endograft procedures. The firm's HeartLook device for measuring pulmonary artery pressure is also under investigation...

Financings In Brief

Remon Medical Technologies: Waltham, Mass. concern announces close of oversubscribed $26 mil. Series C financing, which will help expand U.S. presence of its wireless, intra-body communication technology for use in therapeutic products. First-time investors in the financing round include Guidant, Triathlon Medical Ventures and Medica Venture Partners. Guidant previously incorporated Remon's interactive sensor technology into its Ancure abdominal aortic aneurysm endograft (1"The Gray Sheet" Feb. 18, 2002, In Brief). Other major Remon financiers include Polaris Venture Partners, Concord Ventures, Lilly Ventures, KBL Healthcare Ventures and Ofer Hi-Tech. The privately held firm intends to commercialize its communication technology through a mixture of internal efforts and external strategic collaborations. Remon is now conducting clinical trials of its Impressure device, which offers an on-demand, non-invasive way to monitor intra-aneurysm pressures after endograft procedures. The firm's HeartLook device for measuring pulmonary artery pressure is also under investigation...

FDA Issues Foreign Establishment R&L Final Rule, Plans U.S. Agent Database

FDA plans to unveil by year-end a database designed to help foreign device manufacturers find U.S. agents

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