The results represent the first clinical evaluation of a vero cell-based candidate H5N1 pandemic vaccine...Novagali Pharma SA, of Evry, France, completed enrollment of patients ahead of schedule in a pivotal multi-center Phase III program to evaluate the efficacy and safety of Nova22007 for vernal keratoconjunctivitis...The duration of morning stiffness (the primary clinical endpoint of the study) was significantly reduced in the Lodotra group while under standard IR prednisone no change in morning

Nitec Pharma AG, of Basel, Switzerland, said it saw positive results in a Phase III clinical trial with Lodotra, a new, modified-release tablet that has been developed to optimize the efficacy of orally administered low-dose prednisone in rheumatoid arthritis...NovaDel Pharma Inc., of Flemington, N.J., said it had positive results from a pharmacokinetic study of its improved oral spray formulation of sumatriptan, the active ingredient in London-based GlaxoSmithKline plc's leading migraine remedy

BioAlliance Pharma SA, of Paris, reported that Phase I/II data of its doxorubicin Transdrug for primary liver cancer showed that a 30mg/m2 dose administered via intra-arterial hepatic injection showed an objective response of 16.7 percent in patients following a single injection...Those results were presented at the 7th international conference of the Asian Clinical Oncology Society in Beijing

Two big pharma-backed venture capital funds joined the Geneva-based company's roster of investors...The company aims to take ADX10059 through clinical development, and it plans to participate in its commercialization...Addex also is seeking near-term revenue opportunities by out-licensing additional clinical and preclinical drug candidates that are targeted at larger indications, which are beyond its scope

It is concentrating its resources on three clinical-stage programs: VX-950 (telaprevir) for chronic hepatitis C infection, which is in Phase IIb...The lead drug, VX-950, is partnered with Mitsubishi Pharma Corp., of Osaka, Japan, for the Far East and with Janssen for the rest of the world except North America, where Vertex retained the rights...Auxilium markets Testim 1 percent, a topical testosterone gel, to treat hypogonadism, and it has five projects in clinical development

The product was in-licensed from Tokyo-based Asahi Kasei Pharma Corp. (AKP), which has developed the product in Asian territories and recently submitted a new drug application in Japan...Leading up to the Series A round, AKP and NGN "worked to refine a clinical development plan and business plan," said Jeff Wager, president and CEO of Artisan...Medior was spun-out of Trellis Bioscience Inc., of South San Francisco.

Emisphere Technologies Inc., of Tarrytown, N.Y., said Novartis Pharma AG, of Basel, Switzerland, notified Emisphere of new Phase I data indicating that recombinant human growth hormone can be absorbed when given to growth hormone-deficient patients in a prototype oral formulation using Emisphere's eligen delivery technology...GTx Inc., of Memphis, said an independent Drug Safety Monitoring Board recommended that the company continue clinical development as planned with its two pivotal Phase III

NovaDel Pharma Inc., of Flemington, N.J., started a clinical trial for its formulation of zolpidem oral spray...Clinical trial site initiations and the enrollment of women for the trial began in late July, when the company announced it would submit applications to the FDA for the products: a screening test to detect the presence of 14 high-risk types of HPV and a genotyping test to detect two specific types of HPV-16 and 18, which cause about 70 percent of the cases of cervical cancer

ESBATech intends to start the first clinical trials of ESBA105 in 2007...The second candidate slated for clinical development within 18 months is the oncology drug ACE-041, a GDF antagonist that blocks angiogenesis, even in anti-VEGF resistant tumors...Esprit Pharma Inc., of East Brunswick, N.J., completed a Series B round, raising about $90.8 million, with participation from New Enterprise Associates, Apax Partners Inc., Domain Associates LLC and Montagu Newhall Global Partners, as well as new

Clinical trials are expected to begin later this year...MGI Pharma Inc., of Minneapolis, said the European Medicines Agency has granted Dacogen (decitabine) for Injection orphan designation in acute myeloid leukemia...Dacogen is being co-developed by MGI Pharma and Janssen-Cilag, a unit of New Brunswick, N.J.-based Johnson & Johnson

Abiogen Pharma, of Pisa, Italy, started a Phase II trial of its anti-anxiety drug, ABIO 08-01, in Vienna, Austria, in patients that have generalized anxiety disorder...Cell Genesys Inc., of South San Francisco, said clinical results of GVAX immunotherapy for prostate cancer in patients with early stage disease were published in a June issue of Clinical Cancer Research

BioAlliance Pharma SA, of Paris, presented preliminary results from its Doxorubicin Transdrug Phase I/II trial for primary liver cancer, at the 12th International Symposium on Viral Hepatitis and Liver Disease in Paris...Dendreon Corp., of Seattle, disclosed publication of results of a pivotal Phase III study (D9901) of Provenge, in the July issue of the Journal of Clinical Oncology

Avigen Inc., of Alameda, Calif., plans to begin clinical development of AV650 in the second half of this year after receiving FDA clearance to begin Phase I on the oral small molecule...Phase I data showed it to be well tolerated, in addition to revealing signs of clinical activity in patients with advanced, platinum-resistant or refractory ovarian cancer...VASTox expects to select a lead drug candidate from its program by the first quarter, with clinical trials forecast to start a year later

Acceleron Pharma Inc., of Cambridge, Mass., initiated a Phase I trial of ACE-011, a regenerative therapeutic for bone loss disease, particularly osteoporosis...Celtic Pharma Holdings LP, of New York, reported preliminary results of two Phase II studies of TA-CD, an immunotherapy vaccine for cocaine addiction, including data from a Phase IIa study in volunteers who reported a substantial reduction in the amount of cocaine used after developing good levels of anti-cocaine antibodies in their blood

IDM Pharma Inc., of Irvine, Calif., received a special protocol assessment from the FDA for a Phase II/III trial of Bexidem in superficial bladder cancer...MediciNova Inc., of San Diego, initiated a clinical development program to evaluate MN-221, a selective B2-adrenergic receptor agonist, in status asthmaticus...Results were presented at the New Clinical Drug Evaluation Unit meeting in Boca Raton, Fla

Clinical responses achieved to date include six patients with stable disease from 15 weeks to more than 47 weeks...MGI Pharma Inc., of Minneapolis, said enrollment is complete in its multicenter Phase II alternate dosing trial of Dacogen in patients with myelodysplastic syndromes...In clinical studies to date, the side effects of Lucanix have been minimal compared to those associated with traditional therapies

BioAlliance Pharma SA, of Paris, started a pivotal Phase III trial in the U.S...Curis Inc., of Cambridge, Mass., said preliminary clinical data suggested that a topical Hedgehog antagonist studied in 34 patients with basal-cell carcinoma was generally well tolerated...In November, Theravance entered a collaboration with Tokyo-based Astellas Pharma Inc

It will involve about 10 clinical sites in the U.S., and patient enrollment should be complete by the end of the third quarter...It plans to relocate its corporate headquarters to San Francisco by the beginning of the third quarter, but will retain its clinical development and support activities in Seattle...Tranzyme Pharma, of Research Triangle Park, N.C., completed a Phase I trial of TZP-101, a new chemical entity originating from the company's small-molecule macrocyclic chemistry technology

Nutra Pharma Corp., of Boynton Beach, Fla., said its holding, ReceptoPharm, received approval from the Medicines Health and Regulatory Agency within the British Department of Health for clinical trials in adrenomyeloneuropathy, a rare inherited metabolic disorder that can lead to neurological disability