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

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

Proceeds will be used to fund ACT's clinical activities, including its three ongoing Phase I/II trials for forms of macular degeneration, for development of its other clinical activities and for general corporate purposes...Horizon Pharma Inc., of Deerfield, Ill., priced an underwritten public offering of 21.42 million units, with each unit consisting of one share of its common stock and a warrant to purchase a half share of its common stock...Royalty Pharma has invested $25 million under its royalty

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

Vascular Pharma will receive an up-front payment and milestone payments in exchange for the acquisition rights...Vascular Pharma expects its funding to last through completion of Phase II, getting the company to the point where Janssen may exercise its option...Pharma giants Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, have thrown their hats into the ring, as well

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

The FDA did not cite clinical safety or efficacy issues and did not request additional pre-approval studies, but the agency did raise questions relating to chemistry, manufacturing and controls, as well as issues related to a facility inspection at a third-party manufacturer. (See BioWorld Today, March 28, 2012.) The company completed an end-of-review meeting with the FDA in June to seek clarity from the agency in developing its response...Horizon Pharma Inc., of Deerfield, Ill., filed an S3 shelf

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

A.P. Pharma Inc., of Redwood City, Calif., said it is raising about $53.6 million through a private placement with certain new and existing institutional investors for 102 million shares priced at 5.25 cents per share...A.P. Pharma is developing APF530, a 5-HT3 antagonist formulated with its Biochronomer drug delivery system, for the prevention of both acute- and delayed-onset chemotherapy-induced nausea and vomiting...Shares of A.P. Pharma (OTCBB:APPA) fell 7 cents, or 10.6 percent, to close

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 company plans to use the proceeds to fund clinical trials, R&D activities and other corporate programs...Gemmus Pharma Inc., of San Francisco, closed a Series A round to advance its host-targeted treatment for influenza...The company plans to use the proceeds to cover the costs of clinical trials for its product pipeline, including CompleoTRT A bioadhesive intranasal testosterone gel, which is in a Phase III study in hypogonadism, to acquire manufacturing equipment and for other corporate purposes

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