Advanced Bionics Clarion cochlear implant slated for FDA panel review in July.
This article was originally published in The Gray Sheet
Executive SummaryADVANCED BIONICS CLARION COCHLEAR IMPLANT PMA SLATED FOR JULY 21 REVIEW by FDA's Ear, Nose and Throat Devices Advisory Panel at a meeting in Gaithersburg, Maryland, according to the firm. In support of a premarket approval application for the device, Advanced Bionics will present safety data on a cohort of 273 patients from U.S. and overseas clinical trials and effectiveness data on 68 U.S. subjects followed 6 months post-implant. The firm submitted the PMA to the agency in June 1994.
You may also be interested in...
Moderate growth at Bristol-Myers Squibb and Amgen moved the two companies into the top 10 pharma ranks, based on the most recent Scrip 100 rankings, while declining growth at Gilead and Teva moved those drug makers out.
Momenta Pharmaceuticals has agreed to pay $35.0m to settle claims that it manipulated generic approval processes in the US to shut competitor Amphastar out of the US enoxaparin market.