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July 31, 2014
14:00 EDTHALO, BAXBaxter, Halozyme announce favorable FDA panel recommendation on HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that the Blood Products Advisory Committee of the FDA voted 15-1 that HyQvia, Baxter’s investigational subcutaneous treatment for patients with primary immunodeficiency, has a favorable risk/benefit profile. ''We are hopeful that the positive support for HyQvia is the next step toward providing a new treatment option for patients with primary immunodeficiency in the United States. We look forward to working closely with the FDA as it completes its review,'' said Ludwig Hantson, Ph.D., president of Baxter BioScience. HyQvia was approved in Europe in 2013 for adults with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. HyQvia is a product consisting of human normal immunoglobulin and recombinant human hyaluronidase, licensed from Halozyme.
News For BAX;HALO From The Last 14 Days
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May 27, 2015
08:33 EDTHALOHalozyme and Ventana enter into global agreement to develop companion diagnostic
Halozyme (HALO) and Ventana Medical Systems, a member of the Roche (RHHBY), announced a global agreement to collaborate on the development of, and for Ventana to ultimately commercialize, a companion diagnostic assay for use with Halozyme's investigational new drug, PEGPH20. The Ventana assay will be used to identify high levels of hyaluronan. HA is a glycosaminoglycan that can accumulate around cancer cells. Halozyme has announced plans for rollout of a global phase 3 clinical study in 2016 targeting metastatic pancreatic cancer patients with high HA levels using its PEGPH20 in combination with ABRAXANE and gemcitabine. Under the agreement, Ventana will develop an in vitro diagnostic, under design control, using Halozyme's proprietary HA binding protein, with the intent of submitting it for regulatory approval in the United States, Europe and other countries. The financial terms of the agreement were not disclosed.
May 21, 2015
09:05 EDTBAXBaxter files for European approval of investigational IGSC 20% treatment for PI
Baxter International announced that its BioScience business has submitted a marketing authorization application to 17 competent authorities in Europe following the decentralized procedure for approval of its investigational 20% concentration subcutaneous immune globulin, or IGSC, treatment for primary immunodeficiencies, or PI, a group of disorders in which part of the body's immune system is missing or does not function properly. Results from a separate study of IGSC 20% among patients with PI in North America are expected to be available in the coming months; based on the outcome of this study, Baxter intends to file for U.S. approval of the treatment before the end of 2015.
06:38 EDTBAXNovo Nordisk rejects claims made by Baxter, Reuters says
Novo Nordisk (NVO) rejects claims made by Baxter (BAX) that the company used substances made by Baxter in its Novoeight haemophilia treatment, following Monday's ITC investigation announcement, reports Reuters, citing an email from Novo Nordisk. Reference Link
May 18, 2015
12:24 EDTBAXBaxter sees FY16 sales growth 2%-3%
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12:20 EDTBAXBaxter sees 2H sales growth approximately flat in constant currency
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08:39 EDTBAXBaxter says Baxalta separation on-track for mid-year 2015
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May 15, 2015
17:31 EDTBAXBaxter gets FDA approval for Spain facility to produce Sodium Chloride Injection
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