The company expects to submit a new drug application for the NanoTab System in the third quarter...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies...Perosphere Inc., of Mount Kisco, N.Y., said it received FDA clearance of its investigational new drug application to start clinical testing of PER977 to reverse the anticoagulant activity of unfractionated heparin, low-molecular

SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy...The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is being conducted at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland...The two pivotal studies evaluated the efficacy and safety of LATUDA as monotherapy (PREVAIL 2) or adjunctive therapy (PREVAIL 1) for the treatment of

Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer...Mirna filed its first investigational new drug application with the FDA for MRX34 earlier this year

is more than doubling its cash position with a $30 million registered direct offering, with proceeds to fund R&D activities, namely clinical development of DX-2930, a drug slated to start clinical development for prophylactic use in hereditary angioedema (HAE...Dyax plans to file an investigational new drug application by the end of June and, pending acceptance by the FDA, will move into a Phase I study with healthy volunteers and then begin testing the drug in patients

investigational new drug application in 2014 and begin Phase II studies for psoriasis and atopic dermatitis in the second half of 2014...These data led to Eleven's Phase Ib clinical study of EBI-005 in subjects with dry eye disease, with top-line data from the Phase Ib study expected in the second half of 2013

Arrowhead expects to submit an investigational new drug application this quarter, with dosing in healthy volunteers expected to start in the third quarter...Proceeds will be used to fund ongoing pre-investigational new drug application studies for lead compound NPT002 and to advance fusion proteins for treating neurodegenerative conditions, including Alzheimer's, Parkinson's and Huntington's diseases

The company plans to file a new drug application for the NanoTab system in the third quarter. (See BioWorld Today, Nov. 16, 2012...Ltd., of Germantown, Md., said it filed an investigational new drug application (IND) to begin clinical trials of its adipose-derived stem cell product, RNL-JointStem, for the treatment of osteoarthritis

Celltrion Inc., of Incheon, South Korea, said it received investigational new drug application approval from the UK's Medicines and Healthcare products Regulatory Agency to start a Phase I trial of CT-P27, an influenza antibody shown to have efficacy for pandemic and seasonal flu strains, including various subtypes of influenza viruses...Chimerix Inc., of Durham, N.C., presented the first clinical outcomes data on lead candidate CMX001 in life-threatening infection with adenovirus (AdV), a disease

ActoGeniX NV closed a Series B equity financing round, raising €10.7 million (US$14 million) to move its ActoBiotics program to the investigational new drug application (IND) stage in a second indication of inflammatory bowel disease (IBD...AG014 comprises oral delivery of an anti-TNF antibody with proven clinical efficacy in IBD, resulting in local efficacy and an improved safety profile over systemic drugs...Shares of Northwest (NASDAQ:NWBO) fell 13 cents to close Thursday at $3.77. #kicker123

Fifty percent (eight patients) met the primary endpoint, defined as a reduction in the Mayo score between baseline and completion of treatment, while the remaining eight patients demonstrated a stable clinical condition or minor improvement...SK Biopharmaceuticals, of Seoul, South Korea, said the FDA authorized an investigational new drug application for SKL11508 to treat cognitive impairment associated with schizophrenia

The open-label study under an investigational new drug application is designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adults with relapsed/refractory AML...Regentis raised $10 million last year in a Series C financing to support clinical studies and commercial launch of GelrinC in Europe. (See BioWorld Today, May 15, 2012

Receptos is moving the drug into Phase II testing for orphan disease eosinophilic esophagitis (EoE), with a pre-investigational new drug application (IND) meeting with the FDA this year and an IND filing expected in the first half of 2014...Funds will be used to progress the clinical development program for lead candidate, Pracinostat, its oral histone deacetylase inhibitor for advanced hematologic malignancies, and for other general corporate purposes...Shares of MEI (NASDAQ:MEIP) closed Friday at $8

Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...VG Life Sciences Inc., of San Marino, Calif., disclosed positive results from stage 2 of its pre-investigational new drug application Phase I

Net proceeds will be used to cover costs related to the new drug application for CompleoTRT, making a milestone payment for CompleoTRT, manufacturing scale-up for CompleoTRT and Tefina clinical trials

Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia...Novavax Inc., of Rockville, Md., said top-line data from its Phase II dose-ranging study testing its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age hit its protocol-specified objectives, supporting progression

dosage form of either tedizolid or linezolid with the option to switch to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day of treatment...Based on the findings, Trius plans to file a new drug application for tedizolid and to initiate a Phase III study of tedizolid in patients with severe pneumonia during the second half of the year. (See BioWorld Today, Feb. 14, 2013

Another $406 million could come in the form of clinical, regulatory and commercial milestones, and Enanta would be eligible for tiered, double-digit royalties and a U.S...Net proceeds are expected to support clinical trial costs and acquisition of manufacturing equipment, leasehold improvements and general corporate purposes...Trimel's pipeline includes CompleoTRT, a bioadhesive intranasal testosterone gel for male hypogonadism.

Acorda plans to submit a new drug application under the 505(b)(2) pathway this year...The company also is preparing a clinical program for marketing in Europe and the U.S

The company submitted a supplemental new drug application in December to expand the use to all adults with IDA who have failed or could not tolerate oral iron treatment. (See BioWorld Today, July 1, 2009...The company also said it is initiating a new financing round – about $6 million in new convertible debt – to fund further clinical development