Category: pSivida Corp.
Massachusetts medical device maker pSivida is highlighting the safety of its Iluvien drug-device combination in hopes of finally winning FDA approval for treating patients with diabetic macular edema.
As pSivida gears up to begin distribution of its Illuvien eye treatment in Europe, it plans to re-submit its new drug application to the FDA for the drug/device combination.
It's been a rocky road for pSivida's (NSDQ:PSDV) Illuvien, a drug/device combination for diabetic macular edema, but the company hopes that new trial data will pave the way to regulatory approval in the U.S.
The Iluvien treatment licensed from pSivida to Alimera Sciences for diabetic macular edema is too expensive, the U.K.'s National Institute for Health & Clinical Excellence decides.
Covidien is said to be close to inking a $350 million deal for pulmonary diagnostic tool maker superDimension; also, Medtronic files for senior note offering; pSivida inks 2nd evaluation deal for Durasert eye implant; Viking Systems expands China footprint; BioDirection licenses Nanosys nanowire patents; Cameron Health buyout points to med-tech M&A trend; Covidien, Kensey Nash announce dividends; GPOs: Novation, Premier ink new hospital bed, HIT and wound care products; plus, a Funding Roundup and analysts' ups and downs.
Covidien (NYSE:COV) is set to close a $350 million buyout of Israeli lung diagnosis firm superDimension by the end of the week, according to Israeli business journal Calcalist.
Founded in Tel Aviv by Pinchas Gilboa, Minneapolis-based superDimension, which employs about 120 people worldwide, also has offices in Dusseldorf, Germany.
Zimmer plans cuts and outsourcing at its Warsaw, Ind., headquarters partially to offset the impending burden of a 2.3% medical device tax.
Zimmer Holdings (NYSE:ZMH) announced layoffs at its Warsaw, Ind., headquarters, pointing to the expected burden of the medical device tax as partly responsible for some of the losses.
The orthopedics device maker plans to offset the entire burden posed by the impending 2.3% device levy in 2013 through cost-cutting efforts, part of which include layoffs.