The findings were published in the Journal of Clinical Oncology...An interim analysis and resubmission of the new drug application for Contrave are planned once approximately 87 MACE events have occurred, which Orexigen anticipates will occur in the second half of 2013

The study is designed to assess the clinical impact of the absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogues...Based on that study, the company anticipates that it will file a new drug application in the second quarter of 2013

The company expects to submit a new drug application in PsA to the FDA in the first quarter of 2013 and a combined marketing authorization application in PsA and moderate-to-severe psoriasis to the European Medicines Agency in the second half of 2013. (See BioWorld Today, July 13, 2012...Omeros Corp., of Seattle, said it filed an investigational new drug application to start clinical studies of OMS824, the lead compound from its phosphodiesterase 10 program for schizophrenia and other cognitive

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 first clinical study, to be conducted in the U.S

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...If approved, the product, indicated for the treatment of autoimmune and inflammatory diseases, will enter clinical trials

The company was formed in 2007 with a $33 million Series A and raised another $70 million in 2010. (See BioWorld Today, Oct. 31, 2007, and Sept. 14, 2010.) Clinical development has chugged along just as quickly, with patiromer moving from a Phase I to pivotal studies in five years...In November 2011, the company held an end-of-Phase II meeting with the FDA to gain consensus on patiromer's clinical development plan, including the design of Phase III trials...is acting as sole book-running manager

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...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

Data from the trial suggested clinical benefit, defined as partial response and stable disease of more than four months following up to eight cycles of treatment, with aldoxorubicin at the maximum-tolerated dose in 10 of 13 evaluable patients with relapsed or refractory soft-tissue sarcoma...The company received trial design guidance from the FDA and expects to file an investigational new drug application by year-end

To help fuel its clinical trials programs on lead product candidate, cabozantinib, Exelixis Inc. (NASDAQ:EXEL) said it is planning an underwritten debt offering of $225 million convertible senior subordinated notes due 2019 and a concurrent sale of 20 million shares of its common stock...Recently, the FDA accepted for filing their new drug application (NDA) for for cabozantinib (XL184) in the lead indication of progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC

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...Spectrum Pharmaceuticals Inc., of Henderson, Nev., said data published in the Journal of Clinical Oncology showed first-line consolidation with Zevalin (ibritumomab tiuxetan) injection in patients with mantle-cell lymphoma, following initial therapy consisting of Rituxan (rituximab, Biogen Idec Inc

The fee for filing an application not requiring clinical data or a supplement requiring clinical data will be $979,400, up 6.4 percent from the $920,750 charged this year...Novo Nordisk was remanded to the district court.

The FDA did not cite clinical safety or efficacy issues and did not request additional pre-approval studies, but the agency did raise questions relating to chemistry, manufacturing and controls, as well as issues related to a facility inspection at a third-party manufacturer. (See BioWorld Today, March 28, 2012.) The company completed an end-of-review meeting with the FDA in June to seek clarity from the agency in developing its response...FREEDOM-301 demonstrated a statistically significant

It also filed a new drug application for pomalidomide...In addition to updates on its revenues and clinical programs, Celgene provided information on its stock repurchase program

BHR Pharma LLC, of Phoenix, said it reached its SyNAPSe clinical trial enrollment midpoint of 590 patients...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...ICT-121 is the second dendritic-cell-based vaccine to enter clinical trials

Earlier this month, the FDA accepted the company's resubmitted new drug application as a complete, Class 2 response to its May complete response letter on the drug...Funds also will support clinical work on a second product, a small molecule to be investigated as a possible treatment for a complication of chronic kidney disease.

The company said it expects to complete those trials and to have initial top-line data available early in 2013 and, if successful, will submit a new drug application to the FDA in the first half of next year...and Leerink Swann LLC are acting as joint book-running managers for the offering.

Protalix BioTherapeutics Inc., of Carmiel, Israel, reported clinical data for taliglucerase alfa showing that at 36 months, patients with Gaucher disease had significant improvement in bone marrow fat fraction from baseline, with a mean change of 92 percent...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

It will allow NanoViricides to defray certain additional testing costs for its influenza candidate, leading to an investigational new drug application, and to support the budgeted costs of certain additional equipment needed for production of the future clinical batches of its drug candidates

Cellceutix Corp., of Beverly, Mass., said the FDA approved an investigational new drug application for Kevetrin, an investigational cancer drug...In addition to clearance to proceed with clinical trials, the company also received approval of the protocol from the institutional review board and scientific review committee