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 […]
FDA’s Gottlieb updates on IV bag shortages after Hurricane Maria
FDA commissioner Dr. Scott Gottlieb expects that the shortage of IV fluids caused by Hurricane Maria in Puerto Rico will improve in the coming weeks and months, according to a statement issued by the agency yesterday. The regulatory chief said that the FDA is working with manufacturers like Baxter (NYSE:BAX) and B. Braun to import products […]
Illinois AG sues Baxter for polluting lake
Illinois attorney general Lisa Madigan hit Baxter Healthcare (NYSE:BAX) with a lawsuit yesterday, alleging that the company’s R&D facility dumped contaminated wastewater into a tributary that feeds into Long Lake, polluting the waters beyond allowable limits. Madigan filed the complaint in Lake County Circuit Court and urged the court to force Baxter to stop over-polluting the […]
Here’s what the FDA is doing about IV fluid shortages following hurricanes Maria, Irma
Nine 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 […]
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