The company expects to submit a new drug application for the NanoTab System in the third quarter...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies...Perosphere Inc., of Mount Kisco, N.Y., said it received FDA clearance of its investigational new drug application to start clinical testing of PER977 to reverse the anticoagulant activity of unfractionated heparin, low-molecular

SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy...Destiny Pharma Ltd., of Brighton, UK, reported progress in the Phase I U.S...The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is being conducted at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland

BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety monitoring board (DSMB) again recommended continuing the ReLive Phase III trial without modification...Mirna filed its first investigational new drug application with the FDA for MRX34 earlier this year

Arrowhead expects to submit an investigational new drug application this quarter, with dosing in healthy volunteers expected to start in the third quarter...The firm also has programs in two big pharma partnerships

AG014 comprises oral delivery of an anti-TNF antibody with proven clinical efficacy in IBD, resulting in local efficacy and an improved safety profile over systemic drugs...That's the sweet spot for a number of pharma companies...ERYtech Pharma SA, of Lyon, France, has had its prospectus accepted for a proposed initial public offering on the NYSE Euronext exchange in Paris

Last month, it inked a deal with AbbVie, of Chicago, giving the big pharma firm an option to RPC4046 following the Phase II proof-of-concept trial in EoE...MEI Pharma Inc., of San Diego, priced a public offering of about 2 million shares of common stock at $7.50 apiece, a 9.5 percent discount to Thursday's closing price...Funds will be used to progress the clinical development program for lead candidate, Pracinostat, its oral histone deacetylase inhibitor for advanced hematologic malignancies, and for

Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Cerulean Pharma Inc., of Cambridge, Mass., will present Phase II data for investigational nanopharmaceutical product CRLX101 at the American

Erytech Pharma SA, of Lyon, France, said it received clearance of its investigational new drug application for a Phase I trial of Eryasp (L-asparagainase-loaded erythrocytes) in patients 40 years and older with newly diagnosed acute lymphoblastic leukemia

Another $406 million could come in the form of clinical, regulatory and commercial milestones, and Enanta would be eligible for tiered, double-digit royalties and a U.S...and London-based GW Pharma plc, which is seeking a Nasdaq listing and a capital raise. (See BioWorld Today, March 11, 2013, March 12, 2013, and March 20, 2013.) In other financings news...Net proceeds are expected to support clinical trial costs and acquisition of manufacturing equipment, leasehold improvements and general corporate

A new drug application is expected later this year...at the same unit price.

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program...A new drug application and marketing authorization are planned for the third quarter...Kiadis Pharma BV, of Amsterdam, the Netherlands, said it received a No Objection Letter from Canadian regulators to proceed with a Phase II study testing ATIR, a cell-based product designed to enable stem cell transplantation from mismatched

Cerulean Pharma Inc., of Cambridge, Mass., said the first patient was dosed in a Phase II study of CRLX101, a nanopharmaceutical designed to inhibit both topoisomerase 1 and hypoxia-inducible factor-1 alpha, in extensive-stage small-cell lung cancer sensitive to first-line platinum-based chemotherapy...Galectin Therapeutics Inc., of Norcross, Ga., said it submitted an investigational new drug application for testing GR-MD-02 in nonalcoholic steatohepatitis patients with advanced fibrosis, or fatty

Cerulean Pharma Inc., of Cambridge, Mass., said CRLX101 achieved the predefined gating criterion for advancement into the second stage of a Phase II trial in advanced ovarian cancer...That allows Lorus to initiate a biomarker clinical investigation to further explore the effects of the drug at relevant doses determined in the trial...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmission

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency to initiate a Phase I study of ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR), in TTR-mediated amyloidosis...ALN-TTRsc is the first GalNAc-siRNA to enter clinical development...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study of lead candidate CRLX101 in advanced gastric cancer

Acura Pharmaceuticals Inc., of Palatine, Ill., said it filed an investigational new drug application with the FDA for clinical testing of its hydrocodone bitartrate with acetaminophen formulated using its Aversion Technology...BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial evaluating the efficacy of Livatag (doxorubicin Transdrug) in primary liver cancer and recommended continuing the global, multicenter

EyeGate Pharma Inc., of Waltham, Mass., said it enrolled the last patient in a 200-subject pivotal Phase III study of EGP-437 (dexamethasone phosphate ophthalmic solution) in patients with anterior uveitis...The company is trying to reduce the cost of clinical trials by 50 percent or more, and is partnered with Advanced Monitored Caregiving, a telehealth provider, to that end...Study patients will have in-person visits with the clinical trial staff at the beginning and end of the trial, and all other

Insmed Inc., of Monmouth Junction, N.J., said the company's CLEAR-108 (CLinical Evaluation of Arikace) Phase III European and Canadian registrational study of Arikace (liposomal amikacin for inhalation) for cystic fibrosis patients with Pseudomonas aeruginosa lung infections has enrolled more than 300 patients...Opexa Therapeutics Inc., of The Woodlands, Texas, said Health Canada approved its clinical trial application, enabling the company to expand its ongoing trial in secondary progressive

Shares of MEI Pharma Inc. (NASDAQ:MEIP) popped on Monday morning and climbed throughout the day after the company disclosed a $27.5 million private placement...The company laid groundwork for clinical trials in advance of the financing and plans to begin a "very substantial" randomized Phase II study in the U.S...The company's investigational new drug application for ME-344 was approved by the FDA in April, and the Phase I study of that drug in solid refractory tumors is "80 percent" complete

Thus, Calderon said she "would recommend requiring clinical studies to fully evaluate the abuse potential" of products submitted for review that exceed that level...Earlier this year, Zogenix Inc., of San Diego, submitted a new drug application (NDA) to the FDA for Zohydro (hydrocodone bitartrate) extended-release capsules for chronic pain developed by Alkermes Pharma Ireland Ltd., a subsidiary of Alkermes plc, of Dublin