The Phase III study represents the final stage of product development prior to Trimel's anticipated submission of a new drug application to the FDA for marketing approval in the U.S

Immuron Ltd., of Melbourne, Australia, said the FDA cleared its investigational new drug application to begin a Phase IIb trial of bovine colostrum-derived Imm124-E for nonalcoholic steatohepatitis – a chronic inflammatory disorder of the liver – and fatty liver disease

Galena Biopharma Inc., of Lake Oswego, Ore., said the FDA has approved the investigational new drug application for a Phase II combination trial with NeuVax (E75 plus GM-CSF) and Herceptin (trastuzumab, Genentech Inc./Roche

Arrowhead Research Corp., of Pasadena, Calif., said the FDA cleared its investigational new drug application for obesity candidate Adipotide, a compound designed to specifically target and kill blood vessels supplying white fat tissue

Agile Therapeutics Inc., of Princeton, N.J., completed the final Phase III trial of AG200-15 and is on track to submit the new drug application (NDA) for the combination hormonal contraceptive patch to the FDA during the first quarter

Detailed data will be presented at a medical conference next year, and the companies plan to submit a new drug application for the oral formulation by midyear

Bioheart Inc., of Sunrise, Fla., said it completed an investigational new drug application for the ANGEL trial designed to assess the safety and cardiovascular effects of intramyocardial implantation of autologous adipose-derived stem cells (LipiCell) in patients with chronic ischemic cardiomyopathy

Gilead submitted the new drug application for the single-tablet Quad pill in October. (See BioWorld Today, Sept. 21, 2011...Vivus submitted a new drug application in July for avanafil, a selective phosphodiesterase Type 5 inhibitor, for erectile dysfunction

Aeterna Zentaris Inc., of Quebec City, said the FDA granted an investigational new drug application for a Phase IIa trial of AEZS-130 (macromorelin) in patients with cancer cachexia...Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, said the FDA cleared its investigational new drug application for a Phase I trial testing TKM-Ebola, a systemically delivered RNAi therapeutic that uses the company's lipid nanoparticle (LNP) delivery technology

An investigational new drug application is expected within the next 30 days to 60 days for the Phase II study

Tonix Pharmaceuticals Holding Corp., of New York, said the FDA cleared its investigational new drug application for a comparative pharmacokinetic and bioavailability study of TNX-102, an oral formulation of cyclobenzaprine for treating fibromyalgia syndrome

Vertex filed a new drug application last month seeking approval of Kalydeco in CF patients who have at least one copy of the G551D mutation in the CFTR gene. (See BioWorld Today, June 10, 2011, and Oct. 20, 2011

Circadian Technologies Ltd., of Melbourne, Australia, said the FDA approved the investigational new drug application filed by its wholly owned subsidiary, Vegenics Pty Ltd., to initiate clinical trials of VGX-100, a human antibody that acts against the human VEGF-C protein

The trial will be run under an existing investigational new drug application for MN-221 and has completed FDA review

Cleveland BioLabs Inc., of Buffalo, N.Y., reported that an investigational new drug application for testing CBLB502 in a variety of cancers has been opened with the FDA and the Roswell Park Cancer Institute's investigational review board has approved a protocol for the first trial in advanced cancer patients

MethylGene Inc., of Montreal, received FDA approval for its investigational new drug application to start a Phase II trial evaluating MGCD290, an oral Hos2 fungal inhibitor, in subjects with acute vaginal yeast infection...Oxford BioMedica plc, of Oxford, UK, said the FDA cleared its investigational new drug application for a Phase I/IIa trial of UshStat, a gene-based treatment for Usher syndrome Type Ib

Transcept Pharmaceuticals Inc., of Point Richmond, Calif., received notification from the FDA that its new drug application for Intermezzo (zolpidem tartrate sublingual tablet) has been reclassified as a complete Class 1 reponse with a PDUFA date of Nov. 27. (See BioWorld Today, Sept. 16, 2011

NuPathe said it believes the complete dataset from the NP101-009 trial will be supportive of its planned new drug application resubmission

A safety database of at least 300 patients on therapy with Zohydro for six months and at least 100 patients on therapy with Zohydro for one year is a required component of the 505(b)(2) new drug application Zogenix expects to file with the FDA early next year