Galectin Therapeutics Inc., of Norcross, Ga., said it submitted an investigational new drug application for testing GR-MD-02 in nonalcoholic steatohepatitis patients with advanced fibrosis, or fatty liver disease...Tasimelteon, a melatonin agonist of the human MT1 and MT2 receptors, has had better success in non-24-hour disorder, with positive Phase III data reported in December and again late last month, and Vanda anticipates a new drug application in non-24-hour disorder in mid-2013

The study has been discussed at a pre-investigational new drug application meeting with the FDA

ImmunoCellular Therapeutics Ltd., of Los Angeles, said the FDA allowed the investigational new drug application for ICT-140, a dendritic cell vaccine targeting seven antigens that are overexpressed in ovarian cancer as well as cancer stem cells

Vanda, which reported positive data from the first Phase III trial last month, said it plans to submit a new drug application in mid-2013. (See BioWorld Today, Dec. 19, 2012

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said the FDA accepted its investigational new drug application for Optina in diabetic macular edema...Those data completed the pivotal pharmacokinetic and clinical program for BNX, which BDSI said will enable a new drug application submission in mid-2013

The open-label study, based on an investigational new drug application filed in 2010, will enroll up to eight patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury (AIS) Association A level of impairment, between one and two years after injury

Oramed Pharmaceuticals Inc., of Jerusalem, said it filed an investigational new drug application to begin a Phase II trial of orally ingested insulin candidate ORMD-0801...Orexigen Therapeutics Inc., of San Diego, disclosed progress with the FDA on a faster path to resubmission for a new drug application (NDA) for obesity candidate Contrave (naltrexone SR/bupropion SR

Baxter International Inc., of Deerfield, Ill., said it submitted an investigational new drug application for hemophilia A candidate BAX 855, a full-length longer-acting recombinant Factor VIII developed to increase the half-life of ADVATE (Antihemophilic Factor [Recombinant] Plasma/Albumin-Free Method

Durata expects to report preliminary top-line results from DISCOVER 2, its second Phase III study, this quarter and to reactivate its new drug application for dalbavancin in the U.S

The Phase III study will consist of two parts, each serving as a pivotal study for the purposes of the new drug application submission: Part A will enroll 240 patients in a single-arm study to measure the change in serum potassium from baseline to week four after treatment, while Part B will include patients who responded to treatment in Part A to receive either patiromer or placebo for an additional eight weeks...TG Therapeutics Inc., of New York, said the FDA cleared its investigational new drug

Acura Pharmaceuticals Inc., of Palatine, Ill., said it filed an investigational new drug application with the FDA for clinical testing of its hydrocodone bitartrate with acetaminophen formulated using its Aversion Technology

If the annual rate of those events is close to 1.5 percent, Orexigen may be able to carry out that interim analysis in 2013, with a resubmission of its new drug application as early as the fourth quarter...Transparency Life Sciences LLC, of New York, said the FDA cleared an investigational new drug application for lisinopril in multiple sclerosis

Data were provided in an oral presentation that updated results of a large prospective study on the use of defibrotide in the treatment of hepatic veno-occlusive disease in hematopoietic stem cell transplant patients, from the ongoing treatment investigational new drug application expanded-access protocol

Should the pivotal trial produce positive results, the company said it will be in a position to submit a new drug application via the 505(b)(2) pathway

Avaxia Biologics Inc., of Lexington, Mass., said the FDA cleared its investigational new drug application for AVX-470, an anti-TNF polyclonal antibody derived from the company's oral antibody platform, in ulcerative colitis

Pozen said it has now completed all the clinical trials intended for inclusion in a new drug application package, targeted for submission no later than the end of April 2013

AtheroNova Inc., of Irvine, Calif., said its Russian licensing partner, OOO CardioNova, formally submitted an investigational new drug application in Russia for a Phase I trial of AHRO-001, a product that uses certain pharmacological compounds to regress atherosclerotic plaque deposits and is aimed at preventing and treating atherosclerosis

Ltd., of Seoul, South Korea, said Korean regulators accepted Hanmi's investigational new drug application for KX-01 , a dual src/pretubulin inhibitor aimed at the oncology setting

Agile has filed a new drug application for AG200-15 with the FDA