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News Breaks
March 26, 2014
07:16 EDTHSP, BAXBaxter rationing supplies of nitroglycerin since January, NY Times says
The New York Times reports that Baxter (BAX) has been unable to keep up with demand for injectable nitroglycerin since Hospira (HSP) and American Regent stopped selling their products due to manufacturing problems and delays. The company has been rationing supplies off the drug since January. Reference Link
News For BAX;HSP From The Last 14 Days
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April 17, 2015
16:36 EDTBAXBaxter says results of Phase III clinical trial of BAX 111 met primary endpoint
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April 16, 2015
09:03 EDTBAXBaxter submits application to Japan's MHLW for approval of BAX 855
Baxter International (BAX) announced that the company has submitted a new drug application to Japanís Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII treatment based on ADVATE for patients over 12 years of age with hemophilia A. The submission follows the filing to the United States Food and Drug Administration in late 2014 and is based on positive results from a prospective, global, Phase 3 study of 137 previously treated patients. The results, presented during the European Association for Haemophilia and Allied Disorders meeting in February 2015, demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older. Baxter continues to advance a continuation study for patients who completed the pivotal trial and a Phase 3 study among previously treated patients under the age of 12 with severe hemophilia A. Once the pediatric study has been completed, the company expects to file for marketing authorization with the European Medicines Agency in 2016 and intends to seek post-approval label expansion in the U.S. for previously-untreated pediatric patients. BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 12 years of real-world experience. Through a collaboration with Nektar Therapeutics (NKTR), BAX 855 leverages proprietary pegylation technology designed to extend the duration of activity of the protein in the body. This proprietary technology has been used for over 10 years in a number of approved medicines that treat chronic or serious conditions.
April 15, 2015
08:13 EDTBAXCoherus, Baxter announce amendment to etanercept biosimilar agreement
Coherus BioSciences (CHRS) and Baxter International (BAX) announced that they have amended certain financial terms of their collaboration agreement established in August 2013 regarding the development and commercialization of CHS-0214, an etanercept biosimilar product candidate, for Europe, Canada, Brazil, and certain other markets. Under the terms of the amended agreement, certain existing milestones and funding obligations have been revised, and the collaboration has been expanded to include select pre-commercialization activities. In aggregate, the revised milestone payments may exceed the previous Baxter funding obligations by approximately $12M. Additionally, Baxter has agreed to purchase Coherus common stock in a private placement transaction. All other contractual provisions remain materially unchanged.
07:41 EDTHSPEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
07:38 EDTBAXBaxter removed from the short-term buy list at Deutsche Bank
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April 10, 2015
08:51 EDTBAXBaxter initiates voluntary recall of select lots of IV solutions
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April 7, 2015
11:02 EDTHSPHospira responds to FDA warning letter
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09:30 EDTHSPHospira sent FDA warning letter following site inspection
The FDA sent a warning letter to Hospira, dated March 31, following a May 5-9 and 12-13, 2014 inspection of the company's pharmaceutical manufacturing facility. "We have conducted a detailed review of your firmís response dated June 4, 2014 and note that it lacks sufficient corrective actions. We acknowledge receipt of your firmís correspondence dated August 4, 2014, October 2, 2014, December 4, 2014, and February 9, 2015," the FDA states in its letter. Reference Link

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