The company said those findings supported the general safety of routine vaccine with HPV4 in a clinical care setting to prevent cervical and other genital and reproductive cancers

The trial will have two stages: The first stage will treat patients with escalating doses of SGI-100 and carboplatin to identify the maximum-tolerated dose and preliminary biological and clinical activity, while the second stage will randomize patients to receive SGI-100 plus carboplatin or one of three treatments of choice as determined by the clinical investigator – toptecan, pegylated liposomal doxorubicin or paclitaxel...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of

Clinical trials now represent an aggregate expense of approximately $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...The PCAST report is timely, given that industry concern about the cost and inefficiency of clinical trials prompted formation of the nonprofit TransCelerate BioPharma Inc., the pharma industry's initiative to accelerate drug commercialization that was officially launched last week

The company said the financing will enable them to complete a clinical study to confirm the positive treatment effects of Oxabact previously seen in patients with primary hyperoxaluria, a rare inborn autosomal genetic disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine...Tranzyme Pharma Inc., of Research Triangle Park, N.C., said it closed a registered direct offering of approximately 3 million shares of its common stock at $3.85 per share for gross proceeds

The study is designed to assess the clinical impact of the absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogues...Glenmark's partner, Paris-based Sanofi SA, has licensed all rights to the drug and is carrying out clinical development...Zealand Pharma A/S, of Copenhagen, Denmark, said it dosed the first patient in a Phase I study of ZP2929, a dual-acting glucagon/GLP-1 peptide agonist, in development for treating patients with Type II diabetes and/or patients with

Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said clinical results published in The Lancet showed the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types

Eaton Scientific Solutions Ltd., of Beverly Hills, Calif., a subsidiary of Pristine Solutions Inc., said it is finalizing preparations for a clinical program testing Tropine 3, which contains FDA-approved anticholinergic drug Homatropine, in an oral suspension...Proacta Inc., of San Diego, said the FDA cleared its investigational new drug application for clinical testing of PR610, a hypoxia-activated, irreversible multikinase inhibitor aimed at treating cancer...The first clinical study, to be

If approved, the product, indicated for the treatment of autoimmune and inflammatory diseases, will enter clinical trials...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, published Phase III results from the AFFIRM trial of enzalutamide (MDV3100) in metastatic castration-resistant prostate cancer patients previously treated with docetaxel-based chemotherapy in the New England Journal of Medicine...clinical development of agomelatine for autism and pain

Meritage Pharma Inc., of San Diego, began a Phase II trial of oral budesonide suspension for eosinophilic esophagitis...The trial will be carried out at clinical centers in the U.S

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...Clavis Pharma ASA, of Oslo, Norway, said its partner Clovis Oncology Inc., of Boulder, Colo., initiated a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC

BHR Pharma LLC, of Phoenix, said it reached its SyNAPSe clinical trial enrollment midpoint of 590 patients...ICT-121 is the second dendritic-cell-based vaccine to enter clinical trials

Berg Pharma LLC, of Boston, began a Phase I trial of compound 31543 for chemotherapy-induced alopecia...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study testing CRLX101 in platinum-resistant ovarian cancer...Results were published online in the Clinical Journal of Pain, ahead of the print edition

The company is partnered with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, and recently expanded the collaboration to develop a second protein therapeutic for an undisclosed orphan disease using Synageva's development capabilities and protein expression platform...The company plans to use the proceeds to complete clinical development of lead candidate dalbavancin, currently in a second pivotal Phase III trial in skin infections, and to fund commercialization activities in the U.S...LLC and CRT

Cerulean Pharma Inc., of Cambridge, Mass., completed enrollment in a Phase II trial of CRLX101, in non-small-cell lung cancer (NSCLC) and dosed its first patient in a Phase Ib/IIa trial of the same product in combination with Avastin (bevacizumab, Roche AG) in metastatic renal cell carcinoma (mRCC...Protalix BioTherapeutics Inc., of Carmiel, Israel, reported clinical data for taliglucerase alfa showing that at 36 months, patients with Gaucher disease had significant improvement in bone marrow fat

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said Phase IIa ocular safety results published in the American Journal of Ophthalmology showed that CPP-109 (vigabatrin), a GABA aminotransferase inactivator in clinical trials to treat cocaine addiction, did not cause a decrease in visual acuity or significant peripheral visual field changes with short-term use...Isotechnika Pharma Inc., of Edmonton, Alberta, said 3SBio Inc., of Shenyang, China, received approval in China to begin a

The pivotal clinical study results were presented during the American Academy of Neurology annual meeting in April 2012. (See BioWorld Today, April 30, 2012

Bristol-Myers Squibb Co., of New York, formed a strategic partnership with Emory University in Atlanta to conduct clinical trials involving the pharma's investigational compounds

e-Therapeutics, of Oxford, UK, said that it has started a first clinical trial evaluating its ETS2101 compound as a treatment for cancer...Noxxon Pharma AG, of Berlin, has treated the first patient in a Phase IIa trial of its anti-CCL2/MCP-1 Spiegelmer NOX-E36 in patients with diabetic nephropathy...The subject was treated at the clinical site and has fully recovered, the company said

The request echoes that of the American Society of Clinical Oncologists, which called last week for Congress to put some teeth into the drug shortage reporting requirement. (See BioWorld Today, June 5, 2012.) The conference committee is still hopeful that the House and Senate bills can be reconciled and passed by July 4...We feel it is essential that it be understood that this case could potentially adversely impact ours and other industries whose activities are far removed from the clinical