Coronado Biosciences Inc., of Burlington, Mass., said development partner Dr. Falk Pharma GmbH, of Freiburg, Germany, disclosed the independent data monitoring committee's recommendation to continue Falk's Phase II trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease following an interim analysis of clinical data, blinded to Falk, of the initial 120 patients

If this pivotal preclinical study pans out, we'll try to move into human clinical trials as soon as feasible," Marshall said...miRagen's compounds were developed under a 2010 partnership deal with Santaris Pharma A/S using its Locked Nucleic Acid (LNA) platform...Rodman & Renshaw LLC acted as exclusive placement agent.

Novartis AG, of Basel, Switzerland, said the FDA has placed a full clinical hold on the development program of DEB025 (alisporivir), a first-in-class cyclophilin inhibitor being tested in hepatitis C, following the death of a patient and a number of reported cases of pancreatitis

Three smashing clinical successes by Gilead Sciences Inc.'s nuc drug GS-7977 for hepatitis C virus (HCV) have lit up the 2012 International Liver Congress of the European Association for the Study of the Liver, sending the company's stock up 12 percent Thursday...Novartis AG put its antiviral DEB025 on clinical hold following reports of pancreatitis

The trial will enroll approximately 300 patients and will evaluate Arikace 560 mg, once-daily, delivered via an eFlow Nebulizer System by PARI Pharma GmbH compared to TOBI (inhaled tobramycin solution...It will enroll up to 160 patients at clinical centers in the U.S

The company said the trials showed MoxDuo CR had superior performance in sustained blood levels for up to 24 hours, compared to OxyContin (sustained-release oxycodone) and MS Contin (sustained-release morphine, both Purdue Pharma LP...Threshold Pharmaceuticals Inc., of South San Francisco, received a $20 million milestone payment from Darmstadt, Germany-based Merck KGaA, which was triggered by results from a clinical trial of its drug TH-302 in pancreatic cancer

Assuming the final clinical study report supports the preliminary findings, RedHill said it will consider filing for U.S...RedHill licensed rights to the extended-release version of the anti-emetic drug, dubbed RHB-102, from Scolr Pharma Inc., of Bothell, Wash

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

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

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

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

ViroPharma Inc., of Exton, Pa., said data from the pivotal study for its orphan drug Plenadren (hydrocortisone, modified-release tablet) were published in the Journal of Clinical Endocrinology and Metabolism...Plenadren was developed by Sweden's DuoCort Pharma AB, which ViroPharma acquired after the drug gained approval in Europe for adrenal insufficiency in adults

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

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