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.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.