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News Breaks
May 21, 2014
09:01 EDTBAX, HALOBaxter provides U.S. regulatory update on HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that the U.S. Food and Drug Administration has extended the PDUFA date for its review of the Biologics License Application for HYQVIA, the company’s investigational subcutaneous treatment for patients with primary immunodeficiency. The FDA is requiring additional time to review supplemental data that Baxter provided as part of the ongoing BLA process for HyQvia approval. The PDUFA date has been extended by three months, which is the standard extension period. As part of the FDA’s extended review of the HyQvia BLA amendment, Baxter now expects to participate in a Blood Products Advisory Committee meeting, which the agency has scheduled for July 31.HyQvia was approved by the European Commission for EU member states in 2013 and is available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
News For BAX;HALO From The Last 14 Days
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September 29, 2014
06:36 EDTBAXKamada announces second extension of strategic agreement with Baxter
Kamada (KMDA) announced the second extension to supply Glassia to Baxter (BAX) in its strategic agreement with the biopharmaceutical business of Baxter. Through the extended agreement, Kamada secured $26M in additional revenues of Glassia, the company’s proprietary, ready-to-infuse liquid alpha-1 antitrypsin treatment that is indicated as a chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital AAT deficiency, through 2017. As a result, Kamada expects that total revenue generated through this agreement from October 2010 through end of 2017 will increase to a minimum of $191M compared with a minimum of $110M contained in the original agreement executed in 2010 and a minimum of $165M contained in the May 2013 extension. In addition, the company reports that the supply of Glassia to Baxter has been extended through 2017 and that the transition to royalty payments for Glassia produced by Baxter is not expected to begin before 2018. Until that time, Kamada will continue to produce Glassia for distribution by Baxter. Kamada is confident in its ability to support the increased demand from Baxter throughout the term of the amended agreement.
September 26, 2014
07:45 EDTHALOHalozyme management to meet with UBS
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05:40 EDTBAXPharmaEngine, Merrimack Pharmaceuticals amend MM-398 license agreement
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September 25, 2014
07:37 EDTHALOHalozyme management to meet with UBS
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September 24, 2014
09:05 EDTBAXOn The Fly: Pre-market Movers
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07:44 EDTHALOHalozyme management to meet with UBS
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07:39 EDTBAXMerrimack to hold a conference call
Conference call to discuss the exclusive license and collaboration agreement with Baxter International for the development and commercialization of MM-398 also known as "nal-IRI" will be held on September 24 at 8:30 am. Webcast Link
07:06 EDTBAXBaxter, Merrimack enter exclusive ex-U.S. licensing deal for MM-398
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September 18, 2014
09:05 EDTHALOHalozyme's pancreatic cancer candidate clinical trial approved by FDA to resume
Halozyme announced that the FDA has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase 1b/2 clinical trial. The trial is designed to evaluate Halozyme's investigational drug PEGPH20 in combination with modified FOLFIRINOX chemotherapy in patients with metastatic pancreatic adenocarcinoma. The study will resume under a revised protocol.
September 17, 2014
08:44 EDTBAXJPMorgan biotech analysts hold an analyst/industry conference call
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