In Phase I/II studies, both candidates demonstrated clinical activity, including durable complete responses and an overall survival (OS) benefit...Bergstein previously was medical director of Access Oncology Inc., a privately held clinical-stage biotech that had three oncology compounds in Stage II development when it was acquired in 2004 by Keryx Biopharmaceuticals Inc. (See BioWorld Today, Jan. 9, 2004.) In 2005, Stemline licensed high-throughput drug discovery technology from the University of

The data were published in the April 1, 2012 issue of Clinical Infectious Diseases

CSL Behring is developing rVIIa-FP as a treatment for hemophilia A and hemophilia B patients who have inhibitors as part of the PROLONG 7- FP clinical study program

Data from the open-label trial showing that Glybera affects chylomicron metabolism 14 weeks after a single administration were published online in the Journal of Clinical Endocrinology & Metabolism...Bionovo Inc., of Emeryville, Calif., said the data safety monitoring board recommended continuation of the firm's Phase III study of Menerba (MF101) following an initial review of its clinical safety and tolerability data...The findings, reported online in Stem Cells, indicated one patient showed improved

Clavis Pharma ASA, of Oslo, Norway, said Deerfield, Ill.-based Baxter International Inc...has released its first batch of elacytarabine for clinical use...Secondary endpoint analysis showed superior rates of sustained clinical response 25 days after the end of treatment, and lower recurrence rates within four weeks of treatment

The company was co-founded by former executives of MGI Pharma Inc., a Minneapolis-based firm that marketed several cancer drugs, including Dacogen (decitabine) for myelodysplastic syndromes, and was purchased in 2008 by Eisai Co...The company said it would allocate up to $40 million for the clinical development program for MM-398...The securities are subject to a four-month holding period.

Bristol-Myers Squibb Co., of New York, said research published in the New England Journal of Medicine showed that combining targeted radiation therapy with immunotherapy drug Yervoy (ipilimumab) fostered a strong immune response and a favorable clinical outcome in a patient with melanoma...Novartis AG, of Basel, Switzerland, said a study published in the New England Journal of Medicine found that Signifor (SOM230, pasireotide) normalized cortisol levels and showed clinical benefits in patients with

Baxter International Inc., of Deerfield, Ill., reported long-term data supporting the clinical profile of HyQ, a combo product for use in patients with primary immunodeficiencies

LLC exercise their full overallotment option – are expected to support ongoing clinical development, particularly work on Amigal (migalastat HCl), which is in Phase III testing as a monotherapy for Fabry disease and in Phase II trials in combination with enzyme replacement therapy (ERT...But starting this year, the big pharma firm is shouldering three-fourths of the financial burden...TG Therapeutics Inc., of New York, said it closed a $25 million financing, with proceeds primarily going to support

Horizon Pharma Inc., of Deerfield, Ill., is bringing in $50.8 million in a private placement of about 14 million units – each comprising one share of common stock and a warrant to purchase 0.25 shares – priced at $3.62125 apiece...Proceeds are expected to fund R&D costs for the firm's Cell Pouch System, including the upcoming first clinical trial in diabetics receiving an islet transplant...Funds will be used to support ongoing drug development activities and for general corporate purposes and working

Serendipitously, independent clinical studies of the antecedent biomarkers of AD seem to have corroborated Satori's approach, he added...Despite the huge number of failures, small and large pharma companies have been pouring billions of dollars into the development of molecules that leave a lot to be desired...The company also has an exclusive distribution agreement with Uman Pharma Inc., of Quebec, to commercialize gemcitabine in the U.S. The compound went off patent last year in the U.S

Editor's note: BioWorld has always kept a watchful eye on big pharma developments as they relate to the biotech space...Now we're making it easier for readers by separating pharma business and clinical news into these columns of brief news

Editor's note: BioWorld has always kept a watchful eye on big pharma developments as they relate to the biotech space...Now we're making it easier for readers by separating pharma business and clinical news into these columns of brief news

1 million and will be used to fund R&D efforts, including clinical trials, and for general corporate purposes. (See BioWorld Today, Feb. 10, 2012...The specialty pharma firm also improved its interest terms.

Clinical endpoints are overall survival at two years and progression-free survival at six months...Tiltan Pharma Ltd., of Jerusalem, started a Phase II trial of TL-118 for pancreatic cancer

With data from at least seven clinical trials due this year, along with a Phase III go/no-go decision on its most advanced partnered program, Array Biopharma Inc...The London big pharma firm said earlier this month that it "has a Phase III decision to make, so data from two Phase II trials in second-line lung cancer and melanoma are critical," noted analysts from Edison Investment Research, who called 2012 a "pivotal year that could boost Array's relatively modest valuation...Funds from the latest

Secondary endpoints include levels of brachyury-specific T cells, reduction in brachyury serum markers and circulating tumor cells and evidence of clinical benefit...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, disclosed top-line data from the GetGoal-P Phase III study, showing lixisenatide, a once-daily glucagon-like peptide 1 agonist, hit its primary efficacy endpoint of significantly reducing blood glucose levels compared to placebo (p < 0.0001), with HbA1c

and NewLink Genetics Corp., if not boasting approved products like Horizon Pharma Inc...In earlier stages, ChemoCentryx has CCX662, an independent candidate slated to start clinical trials for glioblastoma multiforme later this year, as well as five other wholly owned preclinical candidates...Funds will be used to develop product candidates CEM-101 and Taksta. (See BioWorld Today, Feb. 6, 2012.)

Editor's note: BioWorld has always kept a watchful eye on big pharma developments as they relate to the biotech space...Now we're making it easier for readers by separating pharma business and clinical news into these columns of brief news