Pending success with the Phase III program, Collegium anticipates submitting a new drug application by the end of 2013...Proacta Inc., of San Diego, said the FDA cleared its investigational new drug application for clinical testing of PR610, a hypoxia-activated, irreversible multikinase inhibitor aimed at treating cancer

The company expects to report results from the study next month and to submit a new drug application with the FDA in the second quarter of next year

Apexigen Inc., of Burlingame, Calif., said its partner, 3SBio Inc., of Shenyang, China, filed an investigational new drug application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China

Grupo Ferrer Internacional SA, of Barcelona, Spain, filed an investigational new drug application for its topical antifungal agent Arasertaconazole nitrate in vulvovaginal candidiasis (VVC), or vaginal thrush

The company received trial design guidance from the FDA and expects to file an investigational new drug application by year-end

BDSI is eligible for milestone payments from Endo totaling $30 million at the completion of study enrollment and database lock for each trial, and for filing of the new drug application with the FDA

ImmunoCellular Therapeutics Inc., of Woodland Hills, Calif., received clearance from the FDA for a physician-sponsored investigative new drug application for a Phase I trial of ICT-121, a dendritic-cell-based vaccine, for solid tumors

pSivida Corp., of Watertown, Mass., said the FDA cleared its investigational new drug application for two Phase III trials testing its injectable sustained-release micro-insert in patients with posterior uveitis

Orexo plans to meet with the FDA this quarter to discuss its planned submission of a new drug application...Rexahn Pharmaceuticals Inc., of Rockville, Md., submitted an investigational new drug application to the FDA for a first-in-human study of RX-5902 to treat advanced or metastatic solid tumors

Cellceutix Corp., of Beverly, Mass., said the FDA approved an investigational new drug application for Kevetrin, an investigational cancer drug

Cellceutix Corp., of Beverly, Mass., said the FDA completed the review of its investigational new drug application for small-molecule cancer drug Kevetrin and cleared the drug to begin Phase I trials

Merck plans to present additional results from the two efficacy studies and to file a new drug application for suvorexant this year

The FDA accepted an investigational new drug application (IND) from Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., for AVP-923, which is in development for Alzheimer's disease

In January, CTI voluntarily withdrew its new drug application for Pixuvri in the U.S...RXi Pharmaceuticals Corp., of Worcester, Mass., said the FDA accepted its investigational new drug application, providing clearance to initiate trials of RXI-109, a self-delivering RNAi compound that selectively targets connective tissue growth factor

Zogenix Inc., of San Diego, said it submitted an investigational new drug application for Relday, a combination of the firm's DosePro needle-free, subcutaneous drug delivery system plus a subcutaneous once-monthly formulation of risperidone for treating schizophrenia

RedHill said, after receiving the final data, it will file a new drug application for RHB-103, which is based on IntelGenx's immediate-release VersaFilm technology...Tranzyme said it has halted new drug application activities for ulimorelin to focus on TZP-102 for diabetic gastroparesis. (See BioWorld Today, March 13, 2012

Viral Genetics Inc., of San Marino, Calif., said a physician-initiated investigational new drug application cleared the FDA's screening process, allowing the company to start the first of at least two proposed trial sites to investigate a potential oncology treatment derived from its Metabolic Disruption Technology (MDT

In October 2011, Janssen filed a supplemental new drug application for the drug, which was developed by Grunenthal GmbH, of Aachen, Germany

Adamas said the FDA agreed to its proposed Phase III safety studies, which, if successful, should be sufficient for a new drug application (NDA...TG Therapeutics Inc., of New York, said the FDA cleared its investigational new drug application for TGTX-1101, also known as ublituximab, a third-generation chimeric monoclonal antibody targeting an epitope on the CD20 antigen found on B lymphocytes