Archive for the Category ◊ Drug Delivery ◊

• Monday, March 10th, 2014

Drug delivery system maker Gerresheimer Peachtree City LP will expand in Fayette County, creating 120 jobs and investing double-digit millions into the expansion. The German company will build an additional 60,000-square-foot manufacturing facility on a 35-acre campus located along Highway 75 North. The facility will produce complex medical devices, such as inhalers for safe medication […]

• Monday, November 18th, 2013

Kimberly-Clark Pursuing Spin-Off Of Health Care Business DALLAS, Nov. 14, 2013 /PRNewswire/ — Kimberly-Clark Corporation (NYSE: KMB) today announced that its board of directors has authorized management to pursue a potential tax-free spin-off of the company’s health care business. A spin-off would create a stand-alone, publicly traded health care company with approximately $1.6 billion in annual net sales and […]

• Monday, November 11th, 2013

California’s Tandem Diabetes plans to offer more than 8.2 million shares of stock at a maximum of $15 apiece for an initial public offering of up to $123.2 million. Tandem Diabetes Care upped the ante on its venture-backed initial public offering, increasing its maximum aggregate price to $123.2 million and pricing shares at between $13-$15 […]

• Tuesday, November 05th, 2013

GE Healthcare – Engström Ventilator and Aespire View, Aisys, Avance, and Avance CS2 Anesthesia Machines Recall Class: Class I Date Recall Initiated: Aug. 28, 2013 Products: – Engström Ventilator and Aespire View, Aisys, Avance, and Avance CS2 Anesthesia Machines To locate serial numbers of the affected products, refer to FDA’s Class I Recall information. These […]

• Friday, November 01st, 2013

GrayBug, LLC Appoints Michael O’Rourke as President & CEO BALTIMORE, Oct. 28, 2013 (GLOBE NEWSWIRE) — GrayBug, LLC, a company that focuses on the development of innovative injectable drug delivery systems to more effectively treat eye diseases, has announced the appointment of Michael O’Rourke as President & CEO, as well as Board Member. “I am […]

• Thursday, October 31st, 2013

King Systems – owned by Ambu A/S – has received a Warning Letter from the U. S. Food and Drug Administration (FDA) relating to an inspection of the King Systems manufacturing site in Noblesville, USA. The Warning Letter references King Systems’ reply to the inspectional observations left by the FDA at the conclusion of the […]

• Friday, October 25th, 2013

Amid a flurry of layoffs and restructuring after failed attempts to win FDA approval, New York device maker Delcath Systems aims for a $7.5 million funding round. New York’s Delcath Systems (NSDQ:DCTH) is looking to raise about $7.5 million through sales of common stock, planning on using the funds for working capital, commercialization efforts, clinical trials and other […]

• Wednesday, October 23rd, 2013

CareFusion 211, Inc., AVEA Ventilators, All Models Recall Class: Class I Date Recall Initiated: September 5, 2013 Product: AVEA Ventilators, All Models This recall affects settings for infants under 5 ½ pounds (2500 grams). The adult and pediatric patient settings are not affected by this recall. Use: The AVEA ventilator is a continuous ventilator intended […]

• Friday, October 18th, 2013

FDA regulators handed Medtronic a warning letter over issues associated with its Paradigm-branded insulin infusion pumps. This comes on top of a Class I recall this past summer over a faulty part in the infusion pump system. On September 19th, regulators alerted the company to violations found during an inspection of its production facility in Northridge, CA. […]

• Tuesday, October 15th, 2013

BellaNovus Development Co. LLC, maker of the Ouchless Needle, has been sold to Cleveland-based medical device firm Gebauer Co. The deal was finalized last week, according to BellaNovus chief operating officer Peter Resnik. Resnik also is managing director of consulting firm Tocqueville Ventures LLC and operating director at private-equity firm Blue Equity LLC. Resnik declined to […]