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News Breaks
May 21, 2014
09:01 EDTHALO, BAXBaxter 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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May 4, 2015
10:03 EDTBAXMerrimack, Baxter announce filing of MAA for MM-398 with EMA
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09:04 EDTBAXBaxter, Merrimack announce filing for European approval of MM-398
Baxter International (BAX) and Merrimack Pharmaceuticals (MACK) jointly announced that Baxter has submitted a marketing authorization application to the European Medicines Agency (EMA) for approval of MM-398, also known as ''nal-IRI,'' an investigational treatment for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The submission follows Merrimack’s recent filing of a new drug application for this indication with the FDA. Both the U.S. and European submissions were based on the positive results of the international Phase 3 NAPOLI-1 study, which was conducted among patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil and leucovorin achieved its primary and secondary endpoints by demonstrating a clinically and statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and LV. The most common Grade 3 or higher adverse events in patients receiving MM-398 and 5-FU/LV were neutropenia, fatigue and gastrointestinal effects. This was the first global Phase 3 study in a post-gemcitabine setting to show a survival benefit in this aggressive disease. The data were presented in June 2014.
April 28, 2015
05:09 EDTBAXMerrimack completes MM-398 NDA submission to FDA
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April 27, 2015
07:04 EDTBAXMerrimack and Baxter complete submission of NDA for MM-398
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April 23, 2015
08:57 EDTBAXBaxter still sees separation costs just above $300M, or 2% of sales
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08:41 EDTBAXBaxter says separation of two companies on track for mid-2015
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07:21 EDTBAXBaxter sees Q2 continuing ops EPS 92c-96c, consensus $1.01
The company expects sales growth of approximately 1%, excluding the impact of foreign currency. Including the impact of foreign currency, the company expects sales to decline approximately 9%-10%. Consensus is $3.92B. Baxter also expects earnings from continuing operations, before special items, of 92c-96c per diluted share. The Q2 earnings guidance excludes approximately 8c per diluted share of projected intangible amortization expense. Reconciling for the inclusion of intangible asset amortization results in expected GAAP earnings of 84c-88c per diluted share, before other special items, for the quarter.
07:01 EDTBAXBaxter reports Q1 adjusted EPS $1.00, consensus 88c
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April 22, 2015
15:50 EDTBAXNotable companies reporting before tomorrow's open
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08:49 EDTBAXCTI BioPharma, Baxter to announce Phase 3 pacritinib data at ASCO late-breaker
CTI BioPharma (CTIC) and Baxter (BAX) announced that data from the randomized Phase 3 PERSIST-1 trial evaluating the investigational agent pacritinib in patients with myelofibrosis will be highlighted in a late-breaking oral presentation at the upcoming American Society of Clinical Oncology, or ASCO, meeting, to be held May 29-June 2 in Chicago. These data have also been selected as part of this year's official ASCO press briefing – titled "Targeted Therapy" – to be held on Saturday, May 30, at 8:00 am CT, the companies said.
April 21, 2015
09:09 EDTBAXJPMorgan medical tech & devices analyst holds analyst/industry conference call
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