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Earnings In Brief

This article was originally published in The Gray Sheet

Executive Summary

AGA Medical: Firm anticipates clearance of its Amplatzer Vascular Plug 4 in the third quarter after answering remaining questions from FDA on the application, AGA Medical CEO John Barr said during an Aug. 3 second quarter earnings call. He noted the questions are "not clinical in nature." The device, which has already launched in Europe, helped drive vascular plug sales up 51% in the quarter to $5.3 million. Corporate sales in the second quarter were $53.8 million, up 7.6% on a reported basis

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Regulatory News In Brief

Hologic panel: FDA's Radiological Devices Panel will weigh in on Hologic's Selenia Dimensions 3-D digital mammography tomosynthesis system on Sept. 24 in Gaithersburg, Md. The firm is seeking PMA approval for both screening and diagnostic indications. The panel is a long time in coming: the firm backed out of a June 2009 panel review to strengthen its case for the product, which it had originally hoped to launch in 2008. The firm most recently forecast approval late this year (1"The Gray Sheet" Feb. 8, 2010). The tomosynthesis technology is designed to address what Hologic calls the primary limitation of 2-D digital mammography, "namely, the superposition of normal breast anatomy that may mask a breast cancer.

Pandemic Response In US Consumer Health Market: OTC Pain Relief And Cough/Cold Purchases

Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.

venBio Raises $394m To Fund Biopharmas Through Human Proof-Of-Concept

Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.





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