The FDA today issued a notice warning of a potential high-risk issue with certain Baxter (NYSE:BAX) Spectrum infusion pump systems. This communication came as part of the FDA’s pilot to enhance its medical device recall program. It follows a letter from Baxter recommending that customers remove certain Spectrum pumps from where they are used or sold. […]
Baxter International
Baxter bolsters fill-finish capabilities with $100M investment in Germany
Baxter International (NYSE:BAX) plans to invest roughly $100 million to expand a sterile fill-finish manufacturing plant in Halle/Westfalen, Germany. BioPharma Solutions (BPS), a subsidiary of Deerfield, Illinois–based Baxter, will manage the new facility. BPS supports pharmaceutical companies through a range of offerings, including scientific support, sterile contract manufacturing and parenteral delivery systems. Get the full […]
Baxter foundation, Direct Relief ink diabetes pact
Baxter (NYSE:BAX) and Direct Relief announced today that they are launching a three-year program awarding funding to health centers and free and charitable clinics that are working to improve diabetes outcomes for patients. The program, Transformative Innovation Awards for Community Health: Incorporating Nutrition to Improve Diabetes Health Outcomes, will award $750,000 to the centers and […]
Mylan launches generic Brevibloc heart injection
Mylan (NSDQ:MYL) said today that it launched a generic version of Baxter‘s (NYSE:BAX) Brevibloc heart drug in the U.S. The company’s injectable product, esmolol hydrochloride in sodium chloride, will be offered in single-dose plastic bags, according to Mylan. The FDA approved Mylan’s drug for the short-term treatment of control of ventricular rate in supraventricular tachycardia, including […]
Baxter wins CE Mark for Evo IQ infusion system
Baxter (NYSE:BAX) said today that its Evo IQ infusion system won CE Mark clearance and regulatory approval in Australia. The company plans to start the launch process for its infusion system in the U.K., Ireland, New Zealand and Australia in the third quarter of this year. Baxter’s Evo IQ infusion system includes an advanced drug library, […]
FDA issues warning for Claris manufacturing site bought by Baxter
The FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month. Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter. The […]
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. “EMR integration is an important step in making infusions safer, which is why Baxter designed the Spectrum IQ system with […]
Baxter beats The Street with Q1 results
Shares in Baxter (NYSE:BAX) rose today in pre-market activity after the medical device maker beat expectations on Wall Street with its first-quarter results. The Deerfield, Ill.-based company posted profits of $389 million, or 71¢ per share, on sales of $2.68 billion for the 3 months ended March 31, for bottom-line growth of 43% on sales growth […]
The flu season is making a shortage of IV fluids worse – here’s what the FDA is doing about it
This year’s flu season has been exceptionally bad – it’s already claimed the lives of dozens of kids and it’s more widespread than any other year on record, according to the Centers for Disease Control and Prevention. It’s also making a shortage of intravenous fluids and IV bags worse than it already is. IV saline […]
Baxter posts Street-beating Q4 earnings, sales
Shares in Baxter (NYSE:BAX) fell slightly this morning after the company topped expectations on Wall Street with its fourth quarter and full-year results. The Deerfield, Ill.-based company swung to a loss in Q4 thanks to a $322 million hit from the recently-enacted U.S. tax reform legislation. Baxter posted -$71 million in net losses for the quarter […]
