TapImmune Inc., of Seattle, said the Mayo Clinic received investigational new drug application allowance for a Phase I trial of the company's HER-2/neu vaccine in breast cancer patients who finished standard Herceptin (trastuzumab, Roche AG)-based therapy and are at high risk of disease recurrence
Lixte Biotechnology Holdings Inc., of East Setauket, N.Y., said it submitted an investigational new drug application for a Phase I trial of lead cancer drug LB-100, which demonstrated in preclinical models an ability to kill cancer cells by inhibiting cancer cell growth and to enhance the killing of cancer cells via widely used drugs such as temozolomide, doxorubicin and docetaxel
ImmunoGen Inc., of Waltham, Mass., said its investigational new drug application for IMGN853,which combines the company's cancer-cell-killing agent DM4 to its M9346A FOLR1-targeting antibody, is now active
Aradigm Corp., of Hayward, Calif., said the FDA approved its investigational new drug application for a pivotal Phase III trial of Pulmaquin (dual-release ciprofloxacin for inhalation) in noncystic fibrosis bronchiectasis...Watson expects to complete the trial by fourth-quarter 2013, followed by the submission of a new drug application to the FDA
Gilead, which reported top-line data from Study 102 in August 2011, submitted a new drug application for Quad late last year. (See BioWorld Today, Aug. 16, 2011
CK Life Sciences International (Holdings) Inc., of Hong Kong, said the FDA cleared the investigational new drug application submitted by its subsidiary, Polynoma LLC, allowing it to proceed with Phase III testing of its melanoma vaccine, manufactured using a combination of antigens from three melanoma cell lines...Marshall Edwards Inc., of San Diego, submitted an investigational new drug application (IND) to the FDA for oncology drug candidate ME-344, its lead mitochondrial inhibitor
The data, which were included in the company's new drug application, showed treatment significantly reduced spleen volume and improved symptoms of myelofibrosis
Tau Therapeutics LLC, of Charlottesville, Va., said the FDA accepted its investigational new drug application for T-type calcium channel blocker mibefradil, and the firm anticipates launching a Phase I trial in healthy volunteers March 2
Tau Therapeutics LLC, of Charlottesville, Va., said the FDA accepted its investigational new drug application for T-type calcium channel blocker mibefradil, and the firm anticipates launching a Phase I trial in healthy volunteers March 2
In August 2011 , Gentium voluntarily withdrew its new drug application for defibrotide after receiving a letter from the FDA citing numerous refuse-to-file issues
S1 Pharmaceuticals Inc., of Jersey City, N.J., said it submitted an investigational new drug application for Phase Ib studies of SIP-104 (Lorexys), its lead candidate for hypoactive sexual desire disorder (HSDD) and female sexual dysfunction
Coronado Biosciences Inc., of Burlington, Mass., said it filed an investigational new drug application for CNDO-109, a biologic designed to prime natural killer cells without the need for cytokines (IL-2) for use in high-risk acute myeloid leukemia (AML
Neurelis Inc., of San Diego, said the FDA cleared the investigational new drug application for NRL-1, an intranasal diazepam formulation, to begin clinical trials in acute breakthrough seizures...An interim analysis and new drug application resubmission is planned once about 87 MACE events have occurred, which is anticipated to be less than two years from the start of the study
TapImmune Inc., of Seattle, said the Mayo Clinic received investigational new drug application allowance for a Phase I trial of the company's HER-2/neu vaccine in breast cancer patients who finished standard Herceptin (trastuzumab, Roche AG)-based therapy and are at high risk of disease recurrence