The program is expected to move into clinical trials within two years

The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is being conducted at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territories for marketing AAT product Glassia and for general corporate purposes

to produce and supply 123I-labeled NAV5001 for Navidea's late-phase clinical trials...The agreement focuses on Nordion's cGMP manufacturing and supply of NAV5001 clinical trial material to be produced at Nordion's Vancouver, British Columbia, facility

Approval was supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical trials, evaluating patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments

Under the agreement, Quintiles will direct clinical trial planning and execution of trials guided by Merck Serono's strategy

filings, Merck's Canadian subsidiary transferred sponsorship of all vernakalant clinical trial applications to Cardiome...It outlines current scientific knowledge about the mechanistic basis of adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis and the optimization of clinical trial designs, including the selection of appropriate clinical trial endpoints, selection of patients who are likely responders to therapeutic stimulation of collateral

Bionomics Ltd., of Adelaide, South Australia, initiated manufacturing activities at Lonza Group Ltd.'s facility in Slough, UK, to enter BNC101 into clinical trials following completion of key preclinical studies...Bionomics hopes to begin clinical trials in 2014

Ltd., of Tokyo, entered a clinical trial agreement under which Daiichi will support and co-sponsor a Phase I study of PER977 to reverse the anticoagulant activity of edoxaban

Idenix Pharmaceuticals Inc., of Cambridge, Mass., reported detailed resistance data from in vitro studies and from a three-day monotherapy clinical trial of IDX719, its once-daily pangenotypic NS5A inhibitor for hepatitis C virus (HCV) infection...TheraCoat Inc., of Ra'anana, Israel, completed a safety and tolerability study and plans to commence efficacy clinical trials in two bladder indications

Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data

Bionomics Ltd., of Adelaide, South Australia, initiated manufacturing activities at Lonza Group Ltd.'s facility in Slough, UK, to enter BNC101 into clinical trials following completion of key preclinical studies...Bionomics hopes to begin clinical trials in 2014

Galapagos plans to initiate preclinical studies in order to enter the first clinical trials within a year...Net proceeds will be used to complete a Phase II Squalamine eye drop clinical trial for the wet form of age-related macular degeneration, to further the clinical development of the eye drops for the treatment of other neovascular ophthalmic disorders, to fund development of other pipeline molecules, and for general corporate purposes

Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data

NeuroDerm Ltd., of Ness Ziona, Israel, said enrollment of patients is ongoing in its Phase IIa clinical trial of ND0612, a treatment for Parkinson's disease

Bristol-Myers Squibb Co., of New York, will invest $250 million to expand its large-scale biologics manufacturing facility in Devens, Mass., introducing biologics development and clinical trial manufacturing capabilities and adding about 350 employees

In other news, GSK recently agreed to a nonexclusive material transfer, patent and know-how license deal with the Health Protection Agency (HPA) for the development and manufacture of a next-generation polio vaccine...Terms include certain milestones and tiered royalty payments to the HPA in return for technology transfer and other licensing rights

Separately, BioMarin said it submitted a clinical trial application with the UK's Medicines and Healthcare Products Regulatory Agency for BMN-190, a recombinant human tripeptidyl peptidase 1 , in neuronal ceroid lipofuscinosis Type 2 (NCL-2), a form of Batten disease

Omeros said it plans to submit an application in Europe to start clinical trials in the second quarter

The new partners plan to start clinical trials following an investigational new drug application later this year