In all, emricasan has completed nine clinical studies, including some at Pfizer, enrolling more than 500 participants, according to Conatus

And although full terms of the Series C funding round were not disclosed, they did include the hitting of milestones on the fibrosis clinical trial, according to PRISM Pharma CFO, Dai Takehara...The company expects to use the remainder of the funding for filing its new drug application (NDA) for tavaborole, a candidate for onychomycosis, and conducting additional clinical studies

Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent

Evoke, a specialty pharma developing a nasal spray formulation of gastrointestinal (GI) drug metoclopramide, is seeking a more modest $23 million and plans to list on Nasdaq as "EVOK...Although the parent company's Microcyn wound care technology has been widely studied and translated into multiple products, the new formulation will require a full complement of clinical studies, he said

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...Promedior Inc., of Lexington, Mass., presented data from a clinical study of PRM-151 at the American Thoracic Society Conference in Philadelphia

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

In addition to Zytiga and Xtandi, the FDA approved Wednesday Xofigo (radium Ra 223 dichloride), an alpha particle-emitting radioactive therapeutic agent from Algeta ASA and partner Bayer AG that demonstrated in clinical studies an overall survival benefit with antitumor effects on bone metastases...Kite Pharma Inc., of Los Angeles, said it closed a $20 million private placement of shares of its Series A preferred stock

Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia...The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15 mg) single doses of NX-1207 for the effect to eradicate or shrink low-grade localized prostate cancer tumors

The company is planning to begin clinical studies in the first half of 2014

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said pinoxacin hydrochloride received approval for clinical studies from the State Food and Drug Administration

Based on those results, the company plans to initiate a repeat-dose clinical study in the third quarter of 2013 to evaluate an intravenous formulation of AT2220 co-administered with Myozyme/Lumizyme...BioAlliance Pharma SA, of Paris, said the FDA approved a U.S

CrystalGenomics Inc., of Seoul, South Korea, said it received a draft of the clinical study report from the recently completed Phase IIa study of CG400549, an antibiotic candidate for methicillin-resistant Staphylococcus aureus (MRSA...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmission

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management

Clavis Pharma ASA, of Oslo, Norway, said it reached the enrollment target for its Phase III CLAVELA study investigating elacytarabine in patients with relapsed or refractory acute myeloid leukemia (AML...A further nine patients are expected to be enrolled at three oncological centers in the U.S. Based on the results, the company will implement a clinical study aimed at evaluating the effects of Reparixin, an inhibitor of the CXCR1 receptor activated by chemokine interleukin 8, in oral monotherapy

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban

The net proceeds will be used for working capital and general corporate purposes, including the continued conduct of the Abili-T clinical study, Opexa's recently initiated Phase IIb trial of personalized T-cell therapy Tcelna in patients with secondary progressive multiple sclerosis.

Cellceutix Corp., of Beverly, Mass., said it has recruited the first patients with advanced solid tumors for clinical studies of cancer candidate Kevetrin...TransTech Pharma Inc., of High Point, N.C., said data from a 399-patient study testing TTP488, a small-molecule drug targeting the receptor for advanced glycation endproducts, demonstrated evidence of slowing cognitive decline over 18 months in patients with mild to moderate Alzheimer's disease

Thus, Calderon said she "would recommend requiring clinical studies to fully evaluate the abuse potential" of products submitted for review that exceed that level

The PCAST report is timely, given that industry concern about the cost and inefficiency of clinical trials prompted formation of the nonprofit TransCelerate BioPharma Inc., the pharma industry's initiative to accelerate drug commercialization that was officially launched last week. (See BioWorld Today, Sept. 26, 2012.) Many of TransCelerate's goals are aligned with those of HHS, which recently retained consulting firm Eastern Research Group Inc...to analyze trial cost data and identify factors