Key Developments: Baxter International Inc (BAX.N)

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Latest Key Developments (Source: Significant Developments)

Baxter International Inc receives U.S. FDA approval for 0.9 pct sodium chloride injection
Friday, 15 May 2015 05:26pm EDT 

Baxter International Inc:Says U.S. Food and Drug Administration has approved its supplemental drug application to establish Sabinanigo, Spain, facility as an approved manufacturing site for 0.9 pct sodium chloride injection, USP, for U.S. market.Says approval includes product presentations in 250 mL, 500 mL and 1000 mL.  Full Article

Baxter International declares quarterly dividend
Tuesday, 5 May 2015 08:55am EDT 

Baxter International Inc:Declares a quarterly dividend of $0.52 per Baxter common share.Payable on July 1 to shareholders of record as of June 1.  Full Article

Merrimack Pharmaceuticals and Baxter BioScience announce completion of new drug application submission to U.S. FDA for MM-398
Monday, 27 Apr 2015 07:00am EDT 

Merrimack Pharmaceuticals Inc and Baxter International Inc:Jointly says Merrimack has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection), also known as "nal-IRI," to the U.S. Food and Drug Administration (FDA).Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.Merrimack requested priority review of the MM-398 NDA by the FDA.FDA and European Medicines Agency have granted MM-398 orphan drug designation for patients with metastatic pancreatic cancer.Enters into an exclusive licensing agreement to develop and commercialize MM-398 outside of the United States.PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize MM-398 in Taiwan.  Full Article

Baxter International Inc gives Q2 2015 guidance; EPS guidance below analysts' estimates
Thursday, 23 Apr 2015 07:00am EDT 

Baxter International Inc:Expects Q2 2015 sales growth of about 1 pct, excluding the impact of foreign currency.Including the impact of foreign currency, the company expects Q2 2015 sales to decline about 9 to 10 pct.Expects Q2 2015 earnings from continuing operations, before special items, of $0.92-$0.96 per diluted share.Q2 2015 guidance excludes about $0.08 per diluted share of projected intangible amortization expense.Reconciling for the inclusion of intangible asset amortization results in expected GAAP earnings of $0.84 to $0.88 per diluted share, before other special items, for the quarter.Q2 2015 revenue of $3.92 bln and EPS of $1.01 - Thomson Reuters I/B/E/S.  Full Article

Baxter International Inc initiates voluntary recall of select lots of IV solutions
Tuesday, 14 Apr 2015 08:00pm EDT 

Baxter International Inc:Announced it is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter.Intravenous administration of a solution containing sterile particulate matter lead to adverse health consequences.The extent and severity of harm depends on the size, number, and composition of the foreign material, and patient’s underlying medical condition.In the absence of in-line filtration, these particles cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.In high-risk patients this lead to serious adverse health consequences.  Full Article

Baxter and Laboratoire Aguettant announce global collaboration for Parenteral Nutrition Trace Elements
Thursday, 2 Apr 2015 08:00am EDT 

Baxter International Inc:Says Baxter International Inc.and Laboratoire Aguettant SAS, Lyon, France, have signed an exclusive global licensing and distribution agreement for trace elements, which are essential micronutrients used in parenteral nutrition (PN) therapy.The collaboration allows Baxter to augment its PN portfolio, currently available in more than 90 countries, with essential trace elements.The agreement includes NUTRYELT concentrate solution for infusion (a multi-trace element product) for adults, and SELENIUM and ZINC (single-trace element products).Says NUTRYELT contains nine essential trace elements consistent with the most recent European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines for trace elements.  Full Article

Baxter International Inc completes CE mark approval for HOMECHOICE CLARIA Automated Peritoneal Dialysis System with SHARESOURCE
Wednesday, 1 Apr 2015 08:00am EDT 

Baxter International Inc:Announced completion of CE marking (market approval) in Europe for HOMECHOICE CLARIA, an automated peritoneal dialysis (APD) system integrated with the SHARESOURCE web-based connectivity platform.Says the APD system is designed with user-friendly features and secure two-way connectivity so healthcare providers can have increased visibility to monitor their patients' home peritoneal dialysis (PD) treatments and adjust prescriptions as necessary.PD is a therapy option performed primarily at home by end-stage renal disease patients.  Full Article

Baxter International Inc expands access to healthcare through collaborations
Monday, 30 Mar 2015 09:00am EDT 

Baxter International Inc:Says public-private collaboration with Singapore's Changi General Hospital to meet growing demand for compounded sterile products and received recognition for organizational excellence, inclusion and diversity and corporate social responsibility efforts.Baxter and Changi General Hospital to establish Centre of Excellence in compounding sciences to develop a new model of care delivery that extends beyond the hospital into the community and a patient's home.Says Centre, planned for launch in 2017 on Changi General Hospital premises.  Full Article

Baxter International Inc announces positive phase III results for BAX 817, investigational recombinant treatment for hemophila A and B patients with inhibitors
Friday, 13 Mar 2015 09:00am EDT 

Baxter International Inc:Says positive results from its Phase III clinical trial evaluating the safety and efficacy of BAX 817, an investigational recombinant factor VIIa (rFVIIa) treatment for people with hemophilia A or B who develop inhibitors.Prospective, open-label, randomized, multicenter trial was designed to assess the safety and efficacy of BAX 817 in male patients ages 12 to 65 with hemophilia A or B with inhibitors over 6-month period using on-demand therapy.Says trial met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours with both on-demand treatment regimens, dosing either 3x90 µg/kg or 1x270 µg/kg, with an overall success rate of 92 percent (98 percent and 85 percent in each dosing group, respectively).Further, 89 percent of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.  Full Article

Baxter International Inc's BioScience Business acquires Biopharmaceutical Company SuppreMol
Wednesday, 4 Mar 2015 09:00am EST 

Baxter International Inc And SuppreMol GmbH:Says that Baxter has acquired SuppreMol for 200 mln Euros (about $225 mln) before working capital and other adjustments.Acquisition includes SuppreMol's early-stage development portfolio of novel biologic immunoregulatory therapeutics for the treatment of autoimmune diseases, focusing on the modulation of Fc receptor signaling pathways, an immune target that could have broad applications in autoimmune disorders.In addition to portfolio, Baxter also acquires and will continue to operate SuppreMol's operations in Munich.  Full Article

Novo Nordisk, Baxter clash over haemophilia drug patent

- Novo Nordisk on Wednesday rejected claims by Baxter International that its drug used substances developed by the U.S. rival, following the launch this week of a U.S. investigation into possible patent infringement.

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