The company expects to submit a new drug application for the NanoTab System in the third quarter...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-weight heparins, fondaparinux and Factor Xa- and IIa inhibitors
The two pivotal studies evaluated the efficacy and safety of LATUDA as monotherapy (PREVAIL 2) or adjunctive therapy (PREVAIL 1) for the treatment of bipolar depression, and supported two supplemental new drug applications that were accepted by the FDA on Oct. 30, 2012
The company expects to report top-line results from the current study in late 2013 or early 2014 and to file a new drug application with the FDA in 2014. (See BioWorld Today, March 20, 2013
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
R-Tech Ueno, of Tokyo, said it submitted an investigational new drug application to start Phase I/II trials of its recombinant human serum albumin-containing ophthalmic solution, in development for severe dry eye
SK Biopharmaceuticals, of Seoul, South Korea, said the FDA authorized an investigational new drug application for SKL11508 to treat cognitive impairment associated with schizophrenia
Oramed Pharmaceuticals Inc., of Jerusalem, submitted an investigational new drug application (IND) to the FDA for its oral insulin candidate, ORMD-0801 , in response to FDA feedback on its initial IND filing Dec. 31, 2012
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
VG Life Sciences Inc., of San Marino, Calif., disclosed positive results from stage 2 of its pre-investigational new drug application Phase I study to test tolerability and toxicity in patients with advanced-stage solid tumors
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
Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said the FDA accepted its investigational new drug application and announced treatment of the first 15 patients in a trial using Ampion to treat osteoarthritis of the knee...Cleveland BioLabs Inc., of Buffalo, N.Y., and Incuron LLC, a joint venture between the firm and Bioprocess Capital Ventures, said they received a notice of allowance from the FDA for an investigational new drug application for CBL0137
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
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
Upsher-Smith's new drug application for USL255 was accepted for review by the FDA with an anticipated PDUFA date in December 2013