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...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, published Phase III results from the AFFIRM trial of enzalutamide (MDV3100) in

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...Clavis Pharma ASA, of Oslo, Norway, said its partner Clovis Oncology Inc., of Boulder, Colo., initiated a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC

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...Horizon Pharma Inc., of Deerfield, Ill., filed an S3 shelf

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

Cerulean Pharma Inc., of Cambridge, Mass., completed enrollment in a Phase II trial of CRLX101, in non-small-cell lung cancer (NSCLC) and dosed its first patient in a Phase Ib/IIa trial of the same product in combination with Avastin (bevacizumab, Roche AG) in metastatic renal cell carcinoma (mRCC...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

Antisense Pharma GmbH, of Regensburg, Germany presented complete data from its Phase I/II study of trabedersen, an antisense compound that specifically inhibits expression of transforming growth factor beta 2 (TGF-β2) – a protein which is overexpressed in advanced tumors – in patients with advanced pancreatic cancer, malignant melanoma or colorectal cancer...CytRx Corp., of Los Angeles, reported Phase Ib/II data showing that tumor-targeting doxorubicin conjugate INNO-206 produced a clinical benefit

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

Acacia Pharma Ltd., of Cambridge, UK, reported Phase II data showing that APD421 significantly reduced the incidence of nausea and vomiting compared to placebo in adult surgical patients at moderate to high risk of suffering postoperative nausea and vomiting (PONV...Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Norgine BV, of Amsterdam, the Netherlands, said top-line results from the primary analysis of ULISES 008, the second of two pivotal Phase III trials evaluating ulimorelin in

In October 2011, Janssen filed a supplemental new drug application for the drug, which was developed by Grunenthal GmbH, of Aachen, Germany...Sigmoid Pharma Ltd., of Dublin, Ireland, said it completed a multicenter, placebo-controlled, randomized Phase II trial of CyCol, its lead candidate, in ulcerative colitis

miRagen has a pre-investigational new drug application meeting with the FDA regarding that compound, and the drug has been granted orphan status in the U.S...Rodman & Renshaw LLC acted as exclusive placement agent.

Cerecor Inc., of Baltimore, said its investigational new drug application for FP01 for the treatment of cough cleared the FDA...Threshold Pharmaceuticals Inc., of South San Francisco, received a $20 million milestone payment from Darmstadt, Germany-based Merck KGaA, which was triggered by results from a clinical trial of its drug TH-302 in pancreatic cancer

The company was co-founded by former executives of MGI Pharma Inc., a Minneapolis-based firm that marketed several cancer drugs, including Dacogen (decitabine) for myelodysplastic syndromes, and was purchased in 2008 by Eisai Co...The company said it plans to file an investigational new drug application for TSR-011 during the second half of the year

LLC exercise their full overallotment option – are expected to support ongoing clinical development, particularly work on Amigal (migalastat HCl), which is in Phase III testing as a monotherapy for Fabry disease and in Phase II trials in combination with enzyme replacement therapy (ERT...But starting this year, the big pharma firm is shouldering three-fourths of the financial burden...TG Therapeutics Inc., of New York, said it closed a $25 million financing, with proceeds primarily going to support

Horizon Pharma Inc., of Deerfield, Ill., is bringing in $50.8 million in a private placement of about 14 million units – each comprising one share of common stock and a warrant to purchase 0.25 shares – priced at $3.62125 apiece...Proceeds are expected to fund R&D costs for the firm's Cell Pouch System, including the upcoming first clinical trial in diabetics receiving an islet transplant...Funds will be used to support ongoing drug development activities and for general corporate purposes and working

With data from at least seven clinical trials due this year, along with a Phase III go/no-go decision on its most advanced partnered program, Array Biopharma Inc...The London big pharma firm said earlier this month that it "has a Phase III decision to make, so data from two Phase II trials in second-line lung cancer and melanoma are critical," noted analysts from Edison Investment Research, who called 2012 a "pivotal year that could boost Array's relatively modest valuation...Funds will be used to

The company plans to file an investigational new drug application with the FDA in late 2012 so that it can begin Phase I trials...Most investors expect clinical data in order to risk a substantial amount of money on a biotech venture...Proceeds will support clinical trials of Androxal and Proellex

BioAlliance Pharma SA, of Paris, said results of a Phase I trial showed a satisfactory safety and a signal of efficacy via local administration of its AMEP biotherapy, so the firm is moving into a European Phase I/II trial testing an intramuscular route of delivery of patients with metastatic melanoma...Based on the study's findings, Spectrum plans to expand its clinical development program for Zevalin to include support for a larger study using Z-beam for ASCT...The existing clinical program includes

EyeGate Pharma Inc., of Waltham, Mass., enrolled the first patient in a Phase III pivotal study of its lead product, EGP-437, for the treatment of anterior uveitis...The double-blind, placebo-controlled, randomized clinical trial in 40 patients who had received at least one anti-TNF treatment was designed to establish the best dose and administration schedule, based on immune response to the Kinoid...multicenter, 70-patient Phase II clinical trial with Fibrocaps – a dry powder topical tissue sealant