hospira inc (HSP) Key Developments
Hospira Receives FDA Clearance for Plum 360 Infusion System
Jan 20 15
Hospira Inc. announced that the company has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum 360 infusion system with Hospira MedNet safety software. The newest in Hospira's portfolio of infusion devices, the Plum 360 system builds on the unique air management and secondary delivery features of Plum A+, while expanding its drug library and wireless capability to enable streamlined electronic medical record (EMR) integration. The Plum 360 infusion system with Hospira MedNet safety software is designed to help improve the safety and efficiency of intravenous (I.V.) medication administration, with benefits including: infusion programming that defaults to the Hospira MedNet drug library for advanced patient safety; large drug library capacity with fast keypad drug search for ease of programming; improved wireless communication to expedite drug library updates and optimize EMR connectivity with automated programming and documentation; smart secondary delivery, so the pump can differentiate between primary and secondary infusion lines and deliver each as intended; and unique air management that doesn't require disconnecting the administration set from the patient to clear the air from the line. Plum 360 will be fully available to customers in the United States in the coming weeks.
Hospira to Close Clayton Manufacturing Facility
Jan 14 15
Hospira announced on January 13, 2015 that it is closing its Clayton manufacturing facility and cutting jobs. The facility employed about 250 people. The closure, scheduled for the second half of 2015, means all products manufactured at the site will be discontinued or transferred to other Hospira locations or third parties. Hospira estimates the layoffs will mean $15 million in employee-related costs including severance.
Hospira Submits New Biologics License Application to U.S. FDA for Epoetin Alfa Biosimilar
Jan 12 15
Hospira Inc. announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Retacrit, a proposed biosimilar to Amgen's EPOGEN (epoetin alfa) and Janssen's PROCRIT (epoetin alfa). The biosimilar application was submitted on December 16, 2014, under the new 351(k) approval pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Biosimilars are biologic drugs that are highly similar to a reference biopharmaceutical product and demonstrate no clinically meaningful differences in terms of the safety, purity and potency of the product. Biosimilars offer high-quality, lower-cost alternatives to reference biologics.
Hospira Inc. Announces Progess on Global Device Strategy
Jan 8 15
Hospira Inc. unveiled significant progress on its global device strategy. The global device strategy, initiated in 2013, establishes a streamlined and modernized device portfolio to address customer needs and to position the company for future innovation and growth, all while supporting continued advancement of device remediation, including quality improvement efforts. Progress includes the lifting of the import alert on the company's portfolio of infusion devices by the U.S. Food and Drug Administration (FDA), the introduction of next-generation pumps and details on future technology development. On January 5, the FDA notified Hospira that it lifted the import alert that previously prohibited U.S. importation of infusion pump devices manufactured in Hospira'sCosta Rica device manufacturing facility, including Hospira's Plum A+ and LifeCare PCA infusion pumps. Hospira is now able to sell these infusion devices to new and existing customers without medical necessity certificates, and will resume the importation of these devices into the United States immediately. Quality systems: Hospira's investments continue to strengthen its global device quality systems and promote continuous improvement to better meet evolving regulatory standards. New product launches in 2015, it expects to offer its customers new next-generation pump technology, including: SapphirePlus - “ Hospira's partner Q Core Medical recently received FDA clearance on this Hospira MedNet ready general-infusion device, which features unique patented technology, innovative design, wireless capability and an intuitive touch screen to help improve the safety and efficiency of I.V. medication administration. Plum 360™ – Hospira is awaiting FDA clearance on this new infusion system, which builds on its unique air management and concurrent delivery features, while expanding its drug library and wireless capability. Hospira MedNet 6.1 – the latest update to the Hospira MedNet safety software enables MedNet to operate with all Hospira pump platforms, building on its leadership position in I.V. Clinical Integration and helping hospitals improve I.V. administration productivity and prevent medication errors. The anticipated launches of these new pumps in 2015, along with ongoing efforts to replace and retire past technologies, are critical in bringing Hospira customers the most advanced medication management systems. Hospira and partner Q Core Medical recently enhanced their collaboration to develop a next-generation platform of pumps, building on both the Sapphire and Plum cassette technologies. The partnership continues to strengthen and supplement Hospira's own research and development efforts. Together, Hospira and Q Core will launch a full spectrum of pumps, including general infusion, PCA, syringe and ambulatory devices that build on the intuitive design of Sapphire and leverage the proven Hospira MedNet software. The development of next generation Plum and Sapphire platforms continues to demonstrate Hospira's long-term commitment to the I.V. infusion market and is a critical part of the company's strategy to build future growth.
Hospira Inc. Receives U.S. FDA Approval of Proprietary Analgesic Dyloject(Diclofenac Sodium) Injection
Dec 30 14
Hospira Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Dyloject (diclofenac sodium) Injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic. Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics. In one controlled, multiple-dose study of adult patients with postoperative pain who had undergone elective abdominal or pelvic surgery, 245 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every six hours starting within six hours after surgery and for up to five days. Approximately 63% of patients in the Dyloject group and 92% of patients in the placebo group took rescue medication within the first 48 hours of the treatment phase. Efficacy was demonstrated by a reduction in pain intensity as measured by the sum of the pain intensity differences over 0 to 48 hours in patients receiving Dyloject as compared to placebo. In a second controlled, multiple-dose study of adult patients with postoperative pain who had undergone elective orthopedic surgery, 277 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every six hours starting within six hours post-surgery and for up to five days. Approximately 74% of patients in the Dyloject group and 92% of patients in the placebo group took rescue medication within the first 48 hours of the treatment phase. Efficacy was demonstrated by a reduction in pain intensity as measured by the sum of the pain intensity differences over 0 to 48 hours in patients receiving Dyloject as compared to placebo.