Further details of the newco will be released later this quarter, though Liquidia said the lead product for the firm will be in glaucoma, with clinical studies expected to start in 2014

Addex said those results supported efficacy data observed in a preclinical nonhuman primate model of levodopa-induced dyskinesia and will be used to inform the dosing in future clinical studies...The article details the results of a clinical study, in which ORMD-0801 was administered to patients with unstable Type I diabetes, in conjunction with their regular anti-diabetes treatment regimens

The pathogen-specific clinical study represents a new development approach to address unmet medical needs for multidrug-resistant bacterial infections

to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...According to the terms, Shasun will be able to use the Debiopharm technology to manufacture synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif

Approval is based on the results from a clinical study in pediatric patients showing that 81 percent achieved healing during the 12-week treatment period and 90 percent retained healing during the ensuing 24-week extension period

Ltd., of Yokohama, Japan, to use its cell-loading system to support clinical studies and commercialize treatment of cancer patients

In separate news, Astellas signed a deal to access the TSUBAME2.0 supercomputer at the Tokyo Institute of Technology to discover candidates for NTDs caused by dengue virus...In other news, The Nasdaq OMX Stockholm's listing committee approved the listing of NeuroVive's shares

The company said it intends to submit a marketing authorization application in Europe with Denmark as the reference member state and contended, based on the positive response in the official minutes of the meeting with the DKMA, that no further clinical studies will be required prior to the submission

To date, 150 patients out of a total of 200 patients have already been recruited in 16 centers in Germany, Austria and Israel...The goal is to modulate the half-life of the therapy to increase efficacy of treatment...The company intends to start clinical trials in the third quarter

Critical Pharmaceuticals Ltd., of Nottingham, UK, completed a second clinical study of CP024, a growth hormone nasal spray in development for growth disorders in children and adults

to test AXL1717, an oral small-molecule insulin-like growth factor 1 receptor inhibitor, in patients with malignant astrocytomas, a type of brain tumor...In other news, Novartis said the FDA approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia

CrystalGenomics Inc., of Seoul, South Korea, said it received a draft of the clinical study report from the recently completed Phase IIa study of CG400549, an antibiotic candidate for methicillin-resistant Staphylococcus aureus (MRSA...GlycoVaxyn will work with Janssen's affiliate, Crucell Holland BV, to develop the vaccine until proof of concept, after which Janssen will be responsible for later-stage clinical studies and worldwide commercialization

GlycoVaxyn will work with Janssen's affiliate, Crucell Holland BV, to develop the vaccine until proof of concept, after which Janssen will be responsible for later-stage clinical studies and worldwide commercialization

Savant said it expects to begin clinical studies of the alpha-3-beta-4 nicotinic

Inc., of Whitehouse Station, N.J., and GE Healthcare, of Princeton, N.J., inked a clinical study collaboration, license and supply agreement for the use of

A further nine patients are expected to be enrolled at three oncological centers in the U.S. Based on the results, the company will implement a clinical study aimed at evaluating the effects of Reparixin, an inhibitor of the CXCR1 receptor activated by chemokine interleukin 8, in oral monotherapy on cancer stem cells and on tumor microenvironment for the treatment of women with early stage breast cancer, before surgery

Arno Therapeutics Inc., of Flemington, N.J., has identified a new immunohistochemistry technique for identifying activated progesterone receptors in breast cancer tumors that may be predictive of response to treatment with onapristone, an investigational progestin receptor antagonist being developed by Arno that has demonstrated antitumor activity in preclinical and clinical studies

The contract, issued under the Russian Federation's "Pharma 2020" development initiative, provides matching funding over a period of about three years, which will be used to support preclinical and clinical studies

Levadex, an inhaled formulation of intravenous drug dihydroergotamine, received a complete response letter following its first submission, with the FDA raising questions relating to chemistry, manufacturing and controls, along with issues relating to a facility inspection at a third-party manufacturer, though no additional clinical studies were requested. (See BioWorld Today, March 28, 2012