SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy

In addition to Zytiga and Xtandi, the FDA approved Wednesday Xofigo (radium Ra 223 dichloride), an alpha particle-emitting radioactive therapeutic agent from Algeta ASA and partner Bayer AG that demonstrated in clinical studies an overall survival benefit with antitumor effects on bone metastases...Receptos will use the proceeds to support clinical work in multiple sclerosis, inflammatory bowel disease and allergic/immune-mediate disorders. (See BioWorld Today, May 10, 2013

These data led to Eleven's Phase Ib clinical study of EBI-005 in subjects with dry eye disease, with top-line data from the Phase Ib study expected in the second half of 2013

In addition to the detailed efficacy and safety results of the ESTABLISH-2 study, which build upon the top-line results previously announced, Trius presented the results of a drug interaction clinical study demonstrating that tedizolid phosphate did not increase blood pressure when used in conjunction with vasoconstrictor drugs such as decongestants...The results of a separate clinical cardiovascular safety study showed that tedizolid was not associated with heart beat abnormalities at up to six

Regentis raised $10 million last year in a Series C financing to support clinical studies and commercial launch of GelrinC in Europe. (See BioWorld Today, May 15, 2012

RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated...Viralytics Ltd., of Sydney, Australia, said it finalized the clinical study report on the Phase I evaluation of Cavatak, administered intravenously to late-stage melanoma, prostate, breast or colorectal cancer patients, with results showing that the oncolytic virus-based drug candidate was well tolerated, with some evidence of stable disease despite most patients only receiving a single dose

BrainStorm Cell Therapeutics Inc., of New York, reported some of the final results from a clinical study evaluating its NurOwn technology in 12 amyotrophic lateral sclerosis (ALS) patients...The Phase I/II trial showed a significantly slower decline in overall clinical and respiratory function, as measured by the ALS functional rating score (ALSFRS-R) and forced vital capacity (FVC) score, respectively, in the six patients who received an intrathecal injection of the cells in the six months

The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15 mg) single doses of NX-1207 for the effect to eradicate or shrink low-grade localized prostate cancer tumors

The company is planning to begin clinical studies in the first half of 2014

Published in Tuesday's Federal Register, the final guidance clarifies the terms "due diligence," "covered clinical study" and "material support...and explains the FDA's review of clinical investigator financial disclosure information.

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said pinoxacin hydrochloride received approval for clinical studies from the State Food and Drug Administration

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium...Based on those results, the company plans to initiate a repeat-dose clinical study in the third quarter of 2013 to evaluate an intravenous formulation of AT2220 co-administered with Myozyme/Lumizyme

Critical Pharmaceuticals Ltd., of Nottingham, UK, completed a second clinical study of CP024, a growth hormone nasal spray in development for growth disorders in children and adults

The net proceeds will be used for working capital and general corporate purposes, including the continuation of the Abili-T clinical study, Opexa's ongoing Phase IIb trial of Tcelna in secondary progressive multiple sclerosis patients

Thus, "Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling" is specifically for use in exploratory and observational studies that are intended to generate genomic hypotheses that will be tested in later confirmatory trials

Sirtex Medical Ltd., of New South Wales, Australia, reported results from an analysis of 548 patients in a clinical study testing Selective Internal Radiation Therapy (SIRT) with SIR-Spheres microspheres in patients with metastatic colorectal cancer...Those data were presented at the American Society of Clinical Oncology's 2013 Gastrointestinal Cancers Symposium in San Francisco

Those data completed the pivotal pharmacokinetic and clinical program for BNX, which BDSI said will enable a new drug application submission in mid-2013...Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said it received approval for clinical studies from Chinese regulators to test Benapenem, a carbapenem drug in the class of broad-spectrum beta-lactam antibiotics, with a Phase I program set to start in the first half of this year

CrystalGenomics Inc., of Seoul, South Korea, said it received a draft of the clinical study report from the recently completed Phase IIa study of CG400549, an antibiotic candidate for methicillin-resistant Staphylococcus aureus (MRSA...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmission

Durata said the secondary endpoint of clinical success at the end of treatment – the expected primary endpoint for regulatory review in Europe – also was met...NovaBay Pharmaceuticals Inc., of Emeryville, Calif., said the first patients have been enrolled in India into its global Phase IIb BAYnovation clinical study, investigating NVC-422 ophthalmic solution as a treatment of adenoviral conjunctivitis, a highly contagious form of "pink eye" for which there is an unmet ocular medical need