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...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

Competitors in atopic dermatitis include Anacor Pharmaceuticals Inc., Oculus Innovtive Sciences and LEO Pharma A/S...Atopic dermatitis was also part of a recent set of collaborations between LEO Pharma A/S and institutions in Australia, France, Germany and the U.S., including the International Institute of Dermatology and Allergy with Charité University of Medicine in Berlin...The company is planning to begin clinical studies in the first half of 2014

Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...A third poster reviews the safety profile of poxviral vaccines from eight separate trials of PROSTVAC and the immunotherapy CV-301...BHR Pharma LLC, of Herndon, Va., said the European Medicines Agency (EMA) granted an orphan medicinal product designation for treating moderate and severe traumatic brain injury (TBI) to its intravenous progesterone infusion agent, BHR-100

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

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, randomized study without modification. (See BioWorld International, June 29, 2011...The overall safety profiles for oritavancin and vancomycin were similar, and oritavancin was found noninferior to vancomycin

BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial of Livatag (doxorubicin transdrug) in primary liver cancer and recommended continuing the study without modification...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...with experience and expertise in stem cell

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

The first cohort of five patients will be completed and analyzed to help establish a safety profile and preliminary efficacy...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

Acorda Therapeutics Inc., of Ardsley, N.Y., reported safety data from more than 62,400 people with multiple sclerosis (MS) taking Ampyra (dalfampridine) extended-release tablets during the first two years of availability in the U.S., with results showing a similar safety profile as observed in clinical trials...AlphaCore Pharma Inc., of Ann Arbor, Mich., said its Phase I trial met the primary endpoint by demonstrating the safety and tolerability of ACP-501 (recombinant human LCAT...The positive

TS01 selectively targets occlusive clots that cause strokes and spares hemostatic clots, resulting in a superior safety profile and reduced risk of intracranial hemorrhage...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of Paris, reported data at the European Association for the Study of Diabetes meeting in Berlin supporting the use of once-daily glucagon-like peptide-1 receptor agonist lixisenatide in combination with basal insulin in Type II diabetes

The pivotal clinical study results were presented during the American Academy of Neurology annual meeting in April 2012. (See BioWorld Today, April 30, 2012...Boehringer Ingelheim GmbH, of Ingelheim, Germany, said findings from an analysis of four Phase III trials, comparing Pradaxa (dabigitran etexilate) to enoxaparin recently published in Thrombosis Research, supported the positive safety profile of Pradaxa for the prevention of venous thromboembolism (VTE) in patients undergoing total knee or

Histogenics Corp., of Waltham, Mass., said Phase II data published in the Journal of Bone and Joint Surgery showed its NeoCart Autologous Cartilage Tissue Implant had a comparable safety profile to microfracture surgery and significantly improved pain and function within six months of treatment in patients with Grade III chondral injury to the femur...Data also showed NeoCart provided significantly greater improvements in a greater number of patients, compared to microfracture, and it is associated

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

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...The drug's safety profile continues to be favorable, with no treatment-related serious adverse events reported...Tranzyme Pharma Inc., of Research Triangle Park, N.C., and Norgine BV, of Amsterdam, the Netherlands, said top-line results

Secondary objectives include describing the safety profile, pharmacokinetics and antitumor response to CBLC137...Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II data published in the Journal of Clinical Oncology confirmed preclinical findings and demonstrated an improved overall survival in a subset of non-small-cell lung cancer (NSCLC) patients with tumors expressing elevated levels of E-cadherin treated with the company's HDAC inhibitor entinostat in combination with EGFR inhibitor

It will enroll up to 160 patients at clinical centers in the U.S...The results in the highest dose group showed a favorable safety profile with no serious adverse events related to ProSavin, average motor function improvement of 30 percent and reduction of L-dopa equivalent therapy

Assuming the final clinical study report supports the preliminary findings, RedHill said it will consider filing for U.S...The Phase I portion of the trial will characterize the safety profile of the combination and identify the appropriate dosing regimen to be used in Phase II

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...Neovacs SA, of Paris, reported full results for its Phase IIa TNF-K-003 clinical trial with TNF-Kinoid in rheumatoid arthritis (RA), indicating the results confirmed TNF-Kinoid's favorable safety profile, ability to induce antibodies to TNF and trend toward the relief of disease symptoms