CoGenesys Inc., of Rockville, Md., said it soon would begin clinical testing of Cardeva, a long-acting form of b-type natriuretic peptide (BNP), following the FDA's review of its investigational new drug application...Locus Pharmaceuticals Inc., of Blue Bell, Pa., is ready to begin a Phase I trial of LP-261, an oral, small molecule for cancer, following the FDA's review of its investigational new drug application

DeCode Genetics Inc., of Reykjavik, Iceland, submitted an investigational new drug application to the FDA for DG051, a compound to prevent heart attack...New River Pharmaceuticals, of Radford, Va., submitted an investigational new drug application to the FDA for NRP409, a Carrierwave triiodothyronine hormone, as a treatment for patients with primary hypothyroidism

InSite Vision Inc., of Alameda, Calif., submitted to the FDA its new drug application for AzaSite for the treatment of bacterial conjunctivitis

Chimerix Inc., of Research Triangle Park, N.C., said the FDA cleared its investigational new drug application for CMX001, an oral antiviral drug candidate for smallpox infections and complications resulting from smallpox vaccine...The trials follow successful filing of an investigational new drug application with the FDA, and will compare the AAT produced by the modified process to currently available Prolastin

Valera Pharmaceuticals Inc., of Cranbury, N.J., submitted an investigational new drug application to the FDA for VP004, a subdermal implant using Valera's Hydron technology to deliver naltrexone, over an extended period of time, for opioid addiction

CuraGen Corp., of Branford, Conn., said the FDA cleared its investigational new drug application for CR011-vcMMAE, a fully human monoclonal antibody-drug conjugate (ADC

The company plans to file an investigational new drug application in the next few months to begin that next phase of testing on the luteinizing hormone-releasing hormone antagonist...Athenagen Inc., of South San Francisco, said the FDA approved an investigational new drug application for ATG002, and it has completed preparation for a Phase I/II trial of the pro-angiogenesis topical wound healing agent in patients with diabetic foot ulcers

Favrille Inc., of San Diego, said its electronic investigational new drug application for FAV-201, a patient-specific immunotherapy to treat T-cell lymphoma, was cleared by the FDA...Locus Pharmaceuticals Inc., of Blue Bell, Pa., submitted an investigational new drug application to begin Phase I testing of its lead compound, LP-261, an orally administered small molecule for cancer

investigational new drug application later this year...It will allow the company to file a new drug application on a rolling basis as data become available

WEX Pharmaceuticals Inc., of Vancouver, British Columbia, received approval for its investigational new drug application to begin a clinical trial of its sodium channel blocker, tetrodotoxin (TTX), administered as a single, subcutaneous dose in healthy volunteers

Top-line data from the FAST-2 study is anticipated in the third quarter, and Kos hopes to file a new drug application by the end of 2006...Inc., of Bothell, Wash., submitted an investigational new drug application for a Phase I study of PYY3-36 nasal spray, its lead candidate in obesity

Cell Therapeutics Inc., of Seattle, agreed with the FDA on a new drug application route for Xyotax (paclitaxel poliglumex) for women with lung cancer

They should be concluded in the fourth quarter, and the filing of a supplemental new drug application for the once-daily formulation is expected in 2007

New River filed a new drug application for NRP104 in pediatric patients with ADHD, and recently initiated a Phase III study of the drug in adult ADHD patients. (See BioWorld Today, May 24, 2006

If study results demonstrate efficacy and safety, ABI intends to conduct a Phase III trial before filing a new drug application...With those results, DOV decided to continue its ongoing Phase III trials in chronic low back pain patients and its Phase II exploratory trial of bicifadine in osteoarthritis, but to delay the start of seven Phase I trials needed to submit a new drug application for bicifadine

GeoVax Inc., of Atlanta, has started clinical trials following FDA clearance of an investigational new drug application for an HIV/AIDS vaccine developed by researchers at GeoVax, the Yerkes National Primate Research Center at Emory University and the Emory Vaccine Center, along with colleagues at the National Institutes of Health and the Centers for Disease Control and Prevention

Neotropix Inc., of Malvern, Pa., said the FDA gave its nod to an investigational new drug application for Seneca Valley Virus (SVV-001...The FDA accepted Novartis' new drug application for SPP100 in April for hypertension

Endo expects to file a supplemental new drug application in the coming weeks for approval

Hollis-Eden Pharmaceuticals Inc., of San Diego, filed an investigational new drug application with the FDA to begin Phase I trials with Neumune in patients at high risk of developing hospital-acquired infections...VioQuest Pharmaceuticals Inc., of Basking Ridge, N.J., said the FDA accepted its investigational new drug application for VQD-002, triciribine-phosphate (TCN-P