Exelixis Inc., of South San Francisco, submitted an investigational new drug application to begin clinical studies of XL019, a selective and orally available small-molecule JAK2 inhibitor
The trial, being conducted under an investigational new drug application with the FDA, is a single-center, randomized, open-label, sequential cohort clinical study to be conducted at Uppsala, Sweden
Mesoblast Ltd., of Melbourne, Australia, said the FDA cleared the investigational new drug application of its U.S.-based sister company, Angioblast Systems Inc
The company, which said high accuracy and sensitivity were the study's top priorities, believes those results will support a new drug application to be submitted in the fourth quarter...Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said the FDA approved its investigational new drug application for PEG-SN38, its PEGylated form of SN38, the active metabolite of the cancer drug irinotecan
Advaxis plans to complete patient reporting in July, with results over the following two months, before submitting an investigational new drug application to conduct additional Phase II trials in the U.S...Celtic Pharmaceuticals Holdings, of Hamilton, Burmuda, has received investigational new drug application approval for TA-NIC, a vaccine for nicotine addiction
Novagali Pharma, of Evry, France, said the FDA has approved its investigational new drug application to conduct a pivotal Phase III clinical trial of its ocular product Nova22007
Exelixis Inc., of South San Francisco, submitted an investigational new drug application for XL765, a small molecule shown in preclinical studies to inhibit the activity of phosphoinositide-3 kinase (PI3K), as well as the mammalian target of rapamycin
Based on those results, the company is preparing to advance its formulation to commercialization and expects to submit a new drug application in the second half of 2008...YM BioSciences Inc., of Mississauga, Ontario, received approval from Japanese regulators for its investigational new drug application to begin a Phase I trial of nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor in solid tumors
A new drug application for Renvela is under review by the FDA for the control of serum phosphorus in patients with chronic kidney disease on dialysis. (See BioWorld Today, Dec. 22, 2006
Data were consistent with a previous Phase III trial, reported in November, and the company anticipates results from one more pivotal study before filing a new drug application in the fourth quarter. (See BioWorld Today, Nov. 20, 2006
Innocoll Inc., of Ashburn, Va., said the FDA approved its investigational new drug application to conduct a Phase II trial of its long-acting CollaRx bupivacaine implant product for the management of post-operative pain in patients undergoing abdominal hysterectomy
RegeneRx Biopharmaceuticals, of Bethesda, Md., has filed an investigational new drug application seeking to begin a Phase Ia human trial for Thymosin beta 4 in healthy volunteers using an intravenous administration that will be tested in patients with ischemic cardiovascular disease in Phase II
Replidyne Inc., of Louisville, Colo., said the FDA indicated that a total of four Phase III trials in three adult respiratory indications will be sufficient for a new drug application for faropenem medoxomil
Advanced Magnetics Inc., of Cambridge, Mass., completed enrollment in its final Phase III study with ferumoxytol in 230 dialysis-dependent chronic kidney disease patients, and expects to file a new drug application in the fourth quarter of this year. (See BioWorld Today, Nov. 20, 2006
Exelixis Inc., of South San Francisco, submitted an investigational new drug application to begin clinical studies of XL019, a selective and orally available small-molecule JAK2 inhibitor