The drug has gone through 12 clinical trials in more than 1,400 subjects already, showing that it knocks down serum bile acid levels safely...Also in the pipeline: Lumena has licensed the patent rights and a package of clinical and non-clinical data for LUM002, another inhibitor of ASBT, also previously in development at the Phase I stage as a cholesterol-lowering agent by Paris-based Sanofi SA...Lumena plans to complete the Phase I clinical program of LUM002 in healthy volunteers later this year

Using ViS' online analytics platform, the initiative is expected to reduce the barriers to global pediatric clinical research by helping drugmakers identify patients, enabling streamlined trial enrollment and site selection...Eventually, it could be used to find research centers, staffing talent and other resources needed to conduct a pediatric clinical trial in a specific region...To get FDA authorization to charge for an investigative drug or for an unapproved use of an approved drug in a clinical

The study, dubbed Gammaglobulin Alzheimer's Partnership, was conducted in collaboration with the Alzheimer's Disease Cooperative Study, a clinical trial consortium supported by the National Institute on Aging

spun out in 2011, and Flexion Therapeutics Inc., of Woburn, Mass., founded by veterans of Eli Lilly and Co.'s Chorus division to advance abandoned early clinical programs through proof of concept. (See BioWorld Today, Feb. 1, 2010, and July 28, 2011.) The $15 million investment in Tacurion will support a Phase II proof-of-concept trial for the drug that should take 18 months to two years to complete...Portola, which seeks a listing on Nasdaq under the ticker "PTLA," filed for the IPO last month

An interchangeable biologic is expected to produce the same clinical results as the reference drug in any given patient...CER Projects Funded The Patient-Centered Outcomes Research Institute approved 51 new awards, totaling $88.6 million over three years, to fund comparative clinical effectiveness research (CER) projects that fall under the first four areas of its research agenda...Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for

CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion...The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining of

shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infection...Shares of Supernus (NASDAQ:SUPN) lost 3 cents Monday to close at $5.12.

clinical trials where a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs

The first clinical trials of the drug, GLPG1790, are expected to start within the next year...On Friday, the company's NASDAQ-listed American depository shares (NASDAQ:PRAN) gained 1 cent, closing at $2.27.

The drug was included in a recent diabetes management report from the American Association of Clinical Endocrinologists

The trial, which will enroll 300 patients, is based on results from a Phase IIb study in newly diagnosed AML patients, 60-75, presented at the American Society of Clinical Oncology conference in 2011...The exercise of the overallotment option brings the total gross proceeds from the offering to $10.75 million. (See BioWorld Today, May 1, 2013.)

The open-label trial will randomize 20 postmenopausal women with estrogen receptor-positive disease who have responded previously to hormone therapy to receive 9 mg of enobosarm once daily until they show clinical progression or have completed 336 days of treatment...The primary endpoint is clinical benefit, which will be assessed at six months...RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it started clinical development of an autologous cell therapy for the treatment of a

Scioderm is advancing SD-101, a topical cream with a unique mechanism of action, into clinical development in epidermolysis bullosa (EB), a rare genetic condition that results in extremely fragile skin that blisters and tears easily...In an open-label Phase II study conducted in children with simplex, recessive dystrophic EB or junctional EB, SD-101 application resulted in complete closure of 88 percent of target chronic lesions within one month.

The following data were reported from European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Berlin...Trius Therapeutics Inc., of San Diego, announced a range of clinical data for the experimental antibiotic tedizolid phosphate (TR-701) and a presentation on linezolid-resistant strain of bacteria...The results of a separate clinical cardiovascular safety study showed that tedizolid was not associated with heart beat abnormalities at up to six times its effective dose

The company filed to go public earlier this month, aiming to raise $86.3 million to support clinical work in multiple sclerosis, inflammatory bowel disease and allergic/immune-mediated disorders...The funding allowed ReXceptor to enter a formal partnership with C2N Diagnostics, which will assist the company with the initiation and coordination of the clinical trial of an AD program licensed from Case Western's Technology Transfer Office and based on discoveries that bexarotene, a medication sold at

When it comes to biopharma, the development cost for one drug can be hundreds of millions of dollars, depending on the number and size of clinical trials the FDA requires...We would like to see CMS use any flexibility that exists to implement the cuts in such a way that the core mission of the agency – to provide care to beneficiaries – is retained and protected," the lawmakers said in a recent letter to CMS.

Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the Journal of Nuclear Medicine published the results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementia

AG014 comprises oral delivery of an anti-TNF antibody with proven clinical efficacy in IBD, resulting in local efficacy and an improved safety profile over systemic drugs...Shares of Northwest (NASDAQ:NWBO) fell 13 cents to close Thursday at $3.77.

Proceeds will be used to advance its gene therapy product for congestive heart failure into clinical development...BofA Merrill Lynch, Barclays and Leerink Swann acted as joint book-running managers, while Stifel and Piper Jaffray served as co-managers. (See BioWorld Today, April 2, 2013.)