Baxter wins FDA nod for Spectrum IQ infusion system

Baxter (NYSE:BAX) said today that it won FDA clearance for its Spectrum IQ infusion system with Dose IQ safety software.

The company touted its system as the first of its kind to include bi-directional electronic medical records integration.

Get the full story at our sister site, Drug Delivery Business News.

The post Baxter wins FDA nod for Spectrum IQ infusion system appeared first on MassDevice.

Baxter inks partnership deal with International Society of Nephrology

Baxter (NYSE:BAX) said today it inked a partnership deal with the International Society of Nephrology looking to advance awareness and therapy for patients with chronic kidney disease, primarily in low and middle-income countries where the disease is growing the fastest.

In the collaborative partnership , Deerfield, Ill.-based Baxter and the ISN will look to support further therapy research and education about chronic kidney disease, while also looking to develop better care models at lower costs.

“ISN and Baxter’s collaboration aims to address the urgent and growing challenge kidney disease is causing healthcare systems in providing quality care to patients globally. Our organization is dedicated to connecting communities to collaborate on supporting greater access to care models that focus on how to improve prevention, diagnosis and treatment of kidney disease,” Dr. David Harris of Australia’s University of Sydney said in a prepared statement.

“It is Baxter’s goal to make renal care available to people in need, while driving better outcomes through new standards. Our partnership with ISN moves us closer to this goal by combining Baxter’s clinical and innovation expertise with ISN’s educational and research expertise in a truly transformative approach to increasing access to care worldwide,” Baxter renal care GM Laura Angelini said in a press release.

In March, Baxter said it that it closed the $153 million acquisition of hemostat and sealant assets from Mallinckrodt Pharmaceuticals (NYSE:MNK).

The post Baxter inks partnership deal with International Society of Nephrology appeared first on MassDevice.

Baxter closes $153m hemostat, sealant asset buy from Mallinckrodt

Baxter (NYSE:BAX) said today that it closed the $153 million acquisition of hemostat and sealant assets from Mallinckrodt Pharmaceuticals (NYSE:MNK).

Baxter announced in January its plan to acquire the stand-alone recombinant thrombin Recothrom and Preveleak surgical sealant for vascular reconstruction.

“We are excited to add both Recothrom and Preveleak to our portfolio of hemostats and sealants to offer surgeons additional options that address different situations when intraoperative bleeding can occur,” advanced surgery president Wil Boren said in prepared remarks. “Our top priority right now is working with customers and distributors to ensure a smooth transition.”

Baxter said it expects its new purchases to add “modestly” to its adjusted earnings per share this year and increasingly after that. The deal includes possible milestone payments for an unspecified amount, the Deerfield, Ill.-based company said.

Recothrom is a stand-alone recombinant thrombin-based product with indications as an aid to hemostasis to control oozing blood and minor bleeding from capillaries and small venules when control of bleeding by standard surgical techniques is ineffective or impractical. Preveleak is designed to seal suture holes during surgical repair of the circulatory system and to reinforce sutured connections between blood vessels. Sales of both products totaled approximately $56 million during the 12 months preceding Sept. 29, 2017.

The post Baxter closes $153m hemostat, sealant asset buy from Mallinckrodt appeared first on MassDevice.

Baxter subsidiary sues B. Braun over blood filtration system

Share

BaxterBaxter (NYSE:BAX) and its subsidiary Gambro filed a patent infringement lawsuit against B. Braun last week, claiming that the German medical device maker’s Omni blood purification system infringes on seven of the patents covering Baxter’s Prismaflex system.

The devices are used to treat patients who have acute kidney injuries and need help filtering out the waste products that accumulate in the blood.

Both the Omni system and the Prismaflex system deliver continuous renal replacement therapy – a form of hemodialysis where the patient’s blood is removed and processed through a hemofilter.

Baxter alleges that B. Braun’s product infringes on a number of the features covered by patents owned by Baxter. In the company’s initial compliant, it points to features like cartridge housings attached to the blood passage and the filtrate line that extend outwardly from the system, which Baxter says infringes upon U.S. Patent No. 6,887,214.

B. Braun’s Omni blood purification system has only been on the U.S. market since November. But Baxter argued in its complaint that B. Braun’s infringement on the seven named patents will result in loss of market share for the Prismaflex system.

“Such losses cannot be adequately compensated by money damages,” the company wrote.

Baxter asked the U.S. Court for the Eastern District of Pennsylvania to stop B. Braun from infringing upon Baxter’s patents and to cover the company’s costs and legal fees.

Here’s what the FDA is doing about IV fluid shortages following hurricanes Maria, Irma

Share

FDANine weeks after hurricanes Maria and Irma brought devastation to Puerto Rico, FDA commissioner Dr. Scott Gottlieb says hospitals across the U.S. are reporting shortages of IV fluids – medical products that are often sourced from Puerto Rico.

Hospitals are specifically noting that 0.9% injection bags of saline, used to inject drugs intravenously, are of short supply. Gottlieb said in a prepared statement that despite the agency’s best efforts, the damage to Puerto Rico’s infrastructure has “greatly exacerbated this supply issue.”

Get the full story at our sister site, Drug Delivery Business News.