The Clinical Global Impression-Change (CGI-C) rating, a subjective physician-completed overall improvement scale, showed that at one and two weeks of treatment, 88 percent and 76 percent of subjects improved on N05 vs. 27 percent and 39 percent, respectively, on placebo (p < 0.001, p = 0.0016, respectively...No safety concerns relating to any of the aforementioned products have been identified in any preclinical and clinical data generated to date and there is no reason to believe that the

Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent

But this time, they'll be listening to a version conducted by the Duke Clinical Research Institute (DCRI), which was hired by GSK to satisfy the FDA's 2010 demand for an independent readjudication of the CV safety results from the unblinded trial as a condition for allowing the drug to remain on the market for a restricted group of patients...The committees also will discuss how the readjudicated data should be weighed in the overall consideration of CV risk with Avandia and whether additional

The study was presented in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...Virttu Biologics Ltd., of Glasgow, Scotland, said an on-going clinical study in the U.S

PharmAthene Inc., of Annapolis, Md., said the FDA lifted the clinical hold placed on a proposed Phase II study of SparVax, a next-generation recombinant anthrax vaccine...In a letter to the company, the FDA acknowledged that PharmAthene had satisfactorily addressed all of the agency's clinical hold issues and that the hold had been lifted, effective immediately

The first-in-man trial will be undertaken by the National Institute of Health Research Experimental Cancer Medicine Centre, based at the Northern Institute of Cancer Research at Newcastle University, as well as at least one other clinical center

The draft reflects changes in the standard of care that have occurred over the past 15 years and provides guidance on clinical trial design...It addresses such areas as limiting the use of a placebo, using an active comparator for safety and efficacy trials, designing dosing regimens, establishing efficacy, developing drug-device combination products and using efficacy endpoints such as clinical remission and prevention of structural damage progression...The agency will accept comments on the draft

The company is exploring the best options for a new clinical study with higher doses of amitifadine in that population

Those results were presented at the New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...Omeros Corp., of Seattle, said it filed a clinical trial application with European regulators to initiate clinical trials of OMS721, its lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2, or MASP-2, program

Prosensa, based in Leiden, the Netherlands, has methodically moved two exon-skipping antisense oligonucleotide drugs into clinical development in Duchenne's muscular dystrophy (DMD) and has three preclinical assets lined up behind them...Although the parent company's Microcyn wound care technology has been widely studied and translated into multiple products, the new formulation will require a full complement of clinical studies, he said...Since we're not going to have clinical data at the time we

The government does not match the experience, expertise, clinical knowledge and infrastructure that an ExpressScripts or UnitedHealthcare brings to the negotiating table," he continued...News of the ruling boosted PharmAthene shares (NYSE Amex:PIP), which closed at $2.03 Tuesday, up 43 cents, or 27 percent.

The agency, however, strongly recommended that Adherex consider other larger clinical trial design alternatives...Adherex said, in light of its current resources, it would take the FDA's recommendations into consideration as it reviews its clinical options

The San Francisco-based company said proceeds, raised exclusively from existing shareholders and partner companies, will advance the clinical development of Pexa-Vec in HCC and in the follow-on indication of refractory colorectal cancer...The company said proceeds will be used for general corporate purposes, including clinical trial expenses and additional regulatory efforts related to erectile dysfunction drug Vitaros (alprostadil 0.3 percent topical cream) and female sexual dysfunction candidate

Results of the PROLASTIN-C SPARK study, a multidose pharmacokinetic clinical trial, were presented at the annual meeting of the American Thoracic Society in Philadelphia

The study is being sponsored by the Alliance for Clinical Trials in Oncology, a cooperative group of the National Cancer Institute (NCI...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies...Promedior Inc., of Lexington, Mass., presented data from a clinical study of PRM-151 at the American Thoracic Society Conference in Philadelphia

Net proceeds will support the launch of Linzess (linaclotide) in the U.S., and fund development to strengthen the clinical profile of Linzess and expand the product label...The company's platform technology is designed to improve drug delivery into internal body cavities.

959, biologics may only be compounded from an approved biologic for a patient for whom the drug produces a clinical benefit, upon receipt of a prescription or medical order...A Medicare beneficiary pays an average cost of $11 for one treatment of compounded bevacizumab compared with about $400 per dose of the approved AMD drugs, the group said. (See BioWorld Today, March 26, 2013.)

Funds will be used to support ongoing and new clinical trials and development and commercialization of Parkinson's psychosis drug pimavanserin and for general corporate purposes...and to fund linaclotide development opportunities to strengthen the clinical profile of Linzess and expand the product label for additional populations and indications...Net proceeds are expected to total about $37.7 million and will be used to fund clinical trials of SFP, an iron compound for hemodialysis patients, and for

Clinical improvements were seen in all patients with reductions in median stool frequency from 23 to 14 per week (p = 0.03) and an improvement in the median Bristol Stool Form Scale assessing stool type from 5.515 to 4.34 (p = 0.05...Marina Biotech Inc., of Bothell, Wash., said licensee Mirna Therapeutics Inc., of Austin, Texas, has begun a Phase I study of MRX34, the first miRNA to advance into a human clinical trial for cancer...Interim data from that study were reported earlier and full data are