Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program...BioAlliance Pharma SA, of Paris, said it inked a collaboration with an undisclosed vaccine company to develop a vaccine application of its Lauriad mucoadhesive technology...In other news, Biotie and partner H. Lundbeck A/S, of Copenhagen, Denmark, said they received marketing authorization from the European Commission for Selincro

Relmada Therapeutics Inc., of Blue Bell, Pa., said an application for a clinical trial authorization (CTA) that was submitted with the UK's Medicine and Health Regulatory Agency (MHRA) to conduct a Phase I pharmacokinetic study with the development product abuse-deterrent LevoCap extended-release (ER) capsules was approved...The Phase I safety study is designed to assess the bioavailability and dose proportionality of three levorphanol extended-release formulations, how they compare with a marketed

Cardiome Pharma Corp., of Vancouver, British Columbia, made its final payment of $13 million to Whitehouse Station, N.J.-based Merck & Co...materials to support ongoing commercialization of Brinavess, and oral API is expected to be sufficient for clinical trials

In the trial, Abilify Maintena (n=269 adult patients) significantly delayed time to relapse compared to placebo (n = 134 adult patients; hazard ratio = 5.03, 95 percent CI = 3.15-8.02, p < 0.0001) In a key secondary endpoint, the percentage of subjects experiencing relapse (i.e., meeting clinical trial criteria for exacerbation of psychotic symptoms/relapse) was also significantly lower with Abilify Maintena compared to placebo at the end of the study (10 percent vs. 40 percent, respectively; p

The clinical trial is a randomized, double-blind, placebo-controlled parallel group study to evaluate the safety, clinical efficacy and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections

Ltd., of Seoul, South Korea, entered an agreement to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates...Under the deal, Samsung will be responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration...and Europe to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis and for active axial spondyloarthritis

Chelsea also plans to initiate a clinical trial in the fourth quarter, given the potential need to verify Northera's durability of effect in a postmarketing study...The company intends to start clinical trials in the third quarter

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

Inc., of Whitehouse Station, N.J., reached an agreement with plaintiffs to settle two federal securities class-action lawsuits related to the statin drug Vytorin and its ENHANCE clinical trial...16 to $2 per share but did not change previously reported non-GAAP results. (See BioWorld Today, Aug. 22, 2008, and March 10, 2009

Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS...The company will receive proceeds of $8 million, which it expects to use to fund clinical trials and for working capital and general corporate purposes

BioCryst's chimpanzee study had been designed to determine if nontoxic doses of BCX5191 would have a potent antiviral effect...Cerulean Pharma Inc., of Cambridge, Mass., said preclinical data showed that CRLX101 in combination with Avastin (bevacizumab, Roche AG) inhibited tumor growth and improved survival vs...Lee's will have an option to negotiate for commercial rights in China

to test AXL1717, an oral small-molecule insulin-like growth factor 1 receptor inhibitor, in patients with malignant astrocytomas, a type of brain tumor...In other news, Novartis said the FDA approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia

The design of the trial later will be adapted, enabling it to separate into three separate personalized arms to test AZD0424 in different combinations alongside standard or other experimental treatments in specific patient populations...In other news, Boehringer Ingelheim said it enrolled the first patients in its Phase III interferon-free (IFN-free) program, HCVerso, testing its IFN-free polymodal regimen combining faldaprevir (BI 201335), a next-wave once-daily protease inhibitor, and BI 207127

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...Based on the outcome of that meeting, Evolva said the next step is to set up a study protocol and file the clinical trial application for a dose-ranging study in diabetics, investigating lower

OncoSec plans to use the proceeds to fund clinical trials and research and development and for other corporate purposes...The company plans to use the proceeds to fund research and development, clinical trials and for other corporate purposes.

Earlier this year, the company inked a potential $33 million strategic alliance with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, to develop and commercialize at least three vaccines using the VLP technology. (See BioWorld Today, March 7, 2012...Shares of Somaxon (NASDAQ:SOMX) soared on the buyout news, gaining 80.3 percent, or $1.18, to close Tuesday at $2.65. (See BioWorld Today, March 19, 2010, July 16, 2010, Aug. 26, 2010, and June 9, 2011...Ltd., pursuant to the existing license

Dompe Group, of Milan, Italy, said it presented the status of a clinical trial to evaluate the safety and pharmacokinetic profile of Reparixin, administered orally in combination with paclitaxel in women with metastatic breast cancer at the San Antonio Breast Cancer Symposium...Galderma Pharma SA, of Lausanne, Switzerland, and Valeant Pharmaceuticals International Inc., of Montreal, reached agreement on terms of a revised North American aesthetics arrangement, resolving Galderma's pending

NKT Therapeutics plans to initiate a clinical trial of NKTT120 in patients with stable sickle cell disease in the first quarter of 2013...Valeant Pharmaceuticals International Inc., of Montreal, and Galderma Pharma SA, of Lausanne, Switzerland, reached agreement on terms of a revised North American aesthetics arrangement, resolving Galderma's pending litigation related to Valeant's acquisition of Medicis Pharmaceuticals International Inc., of Scottsdale, Ariz

Apexigen Inc., of Burlingame, Calif., signed a manufacturing supply agreement with Boehringer Ingelheim GmbH, of Ingelheim, Germany, under which the big pharma firm will provide cell line development with the high expression BI-HEX system, full process and method development, scale-up and clinical Phase I supply for APX005, a humanized monoclonal antibody designed to target CD40 for treating cancer...Gentium SpA., of Villa Guardia, Italy, inked an agreement with the National University Corporation