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

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

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

The money should carry the new company "for about three years-plus," Worlund said, long enough to get clinical proof of concept with a lead program...Karyopharm is expected to present data from its Phase I study testing lead SINE program KPT-330 in solid tumors at the upcoming American Society of Clinical Oncology meeting in Chicago...Founded in 2009, Karyopharm previously raised about $32 million, including a $20 million Series A round in late 2010 and a $10 million Series A2 round in 2011. (See

In its filing, the company said it plans to use proceeds from the IPO to fund the clinical development of lead candidate ataluren (formerly PTC124) in Duchenne's muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF), to seek marketing approval of ataluren in the indications in the U.S...On Friday, the Vetex's shares (NASDAQ:VRTX) gained $1.60, closing at $79.49.

The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS...Additional edata will be presented at the annual meeting of the American Society of Clinical Oncology in Chicago...ACT is currently enrolling patients in three clinical trials in the U.S

Data from a single-arm, 333-patient Phase II trial reported at the American Society of Hematology meeting in December demonstrated quizartinib's high response rate in relapsed/refractory FLT3-ITD-positive patients, with results besting clinical outcomes reported for other kinase inhibitors...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories

Sangamo BioSciences Inc., of Richmond, Calif., said it presented new clinical data, which demonstrated that SB-728-T treatment resulted in a reduction in the HIV reservoir in HIV-infected subjects, at the 16th Annual Meeting of the American Society of Gene and Cell Therapy in Salt Lake City...HIV-infected subjects enrolled in an ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T, which resulted in a durable increase in total CD4 T-cells driven by increased ZFN

Proceeds will be used to fund ongoing and new clinical trials and development and commercialization efforts for pimavanserin, as well as activities for other product candidates and for general corporate purposes...Those personalized and targeted immunotherapies are aimed at providing significant and durable clinical benefit regardless of tumor origin, disease stage and prior treatments. (See BioWorld Today, Oct. 17, 2012...Receptos will use the proceeds to support clinical work in multiple sclerosis

The PROCEED (PROve Clinical Efficacy and Effect of Delafloxacin) study is designed to test delafloxacin 300 mg, given intravenously every 12 hours, compared to vancomycin 15 mg/kg plus aztreonam 2 g I.V., also given every 12 hours...The study includes clinical and microbiological endpoints to assess the efficacy...Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II results published in the Journal of Clinical Oncology showed that HDAC inhibitor entinostat extended both progression-free

With an eye on streamlining the review of clinical trials with low biosafety risks, the National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid molecules