Tag-Archive for ◊ Drug Delivery ◊

• 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 […]

• Wednesday, October 02nd, 2013

Just weeks after receiving honors as the Orleans County Chamber of Commerce Business of the Year, Baxter International Inc. has laid off nearly 100 employees at the site. Company officials confirmed Thursday morning the layoffs, but insisted the facility remains integral to its operations John O’Malley, spokesman at the Deerfield, Ill.-based company (NYSE:BAX), said in an email response that […]

• Monday, September 23rd, 2013

Retractable Technologies, Inc. Announces Verdict LITTLE ELM, Texas–(BUSINESS WIRE)–Retractable Technologies, Inc. (NYSE MKT: RVP), a leading maker of safety medical devices, announced today that a Tyler, Texas jury returned a verdict in the litigation of Retractable Technologies, Inc. v. Becton, Dickinson and Company in favor of Retractable. After a six year battle, the verdict vindicates […]