Clinical development will be conducted by River Vision Development Corp., which licensed teprotumumab from Roche...The work was presented at the New York Academy of Sciences Conference on Probiotics, Prebiotics and the Host Microbiome: The Science of Translation, and results indicated that RP-G28 significantly altered the microbiomes of 82 percent of the study participants who received the treatment

Bristol-Myers Squibb Co., of New York, reported year two data from the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naïve rheumatoid arthritis Subjects With Background Methotrexate) trial of 646 patients comparing the safety and efficacy of the subcutaneous formulation of abatacept (Orencia) vs...The study demonstrated the superiority of ozenoxacin 1 percent cream, applied topically for five days, compared to placebo on both clinical and bacteriological endpoints by end-of-therapy

The new language makes it clear that "sponsors may have to demonstrate clinical superiority to obtain orphan-drug exclusivity even if they did not have to submit a plausible hypothesis of clinical superiority to obtain...Comments on the list and proposed rule are due by Aug. 12.

Autifony Therapeutics Ltd., of London, said Pfizer Venture Investments, the venture capital arm of Pfizer Inc., of New York, invested £5 million (US$7.7 million) to join existing investors SV Life Sciences, Imperial Innovations plc and UCL Business plc in its Series A financing round...The financing is expected to fund the lead program to clinical proof of concept for at least one hearing disorder indication. (See BioWorld Today, Aug. 23, 2011

The Clinical Global Impression-Change (CGI-C) rating, a subjective physician-completed overall improvement scale, showed that at one and two weeks of treatment, 88 percent and 76 percent of subjects improved on N05 vs. 27 percent and 39 percent, respectively, on placebo (p < 0.001, p = 0.0016, respectively...Keryx Biopharmaceuticals Inc., of New York, presented updated efficacy and safety data from the Phase III long-term trial of Zerenex (ferric citrate), the company's ferric iron-based phosphate

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

The government does not match the experience, expertise, clinical knowledge and infrastructure that an ExpressScripts or UnitedHealthcare brings to the negotiating table," he continued...In a September 2011 ruling, the lower court awarded Annapolis, Md.-based PharmAthene half the net profits, after the first $40 million, from SIGA's ST-246 in the first 10 years of sales, as well as from any other orthopox product SIGA develops that's derived from the same family of tricyclononenes. (See BioWorld

The agency, however, strongly recommended that Adherex consider other larger clinical trial design alternatives...Bellus' partner, Auven Therapeutics, of New York, (previously Celtic Therapeutics) is funding 100 percent of the development costs of Kiacta

The company said proceeds will be used for general corporate purposes, including clinical trial expenses and additional regulatory efforts related to erectile dysfunction drug Vitaros (alprostadil 0.3 percent topical cream) and female sexual dysfunction candidate Femprox (alprostadil 0.4 percent topical cream...Stemline Therapeutics Inc., of New York, said underwriters exercised in full their option to purchase an additional 620,689 shares of common stock at $14.50 each, generating an additional $9

The study is being sponsored by the Alliance for Clinical Trials in Oncology, a cooperative group of the National Cancer Institute (NCI...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

Oligomerix Inc., of New York, completed a $2.8M Series B financing, which included both the issuance of new convertible preferred shares and warrants...Stemline Therapeutics Inc., of New York, closed a public offering of 4,137,931 shares of common stock at $14.50 per share

Intercept Pharmaceuticals Inc., of New York, reported initial results from OBADIAH, an ongoing Phase IIa trial of obeticholic acid (OCA) as a treatment for primary bile acid diarrhea (PBAD), showing that treatment with OCA is associated with statistically significant increased levels of fibroblast growth factor 19 (FGF19) and improvement in clinical symptoms in patients with PBAD...Clinical improvements were seen in all patients with reductions in median stool frequency from 23 to 14 per week (p

In 2007, the company inked a blockbuster deal with Pfizer Inc., of New York, focused on its Gene Expression Modulation by Small-molecules (GEMS) technology platform, which identifies small molecules that regulate post-transcriptional control mechanisms...On Friday, the Vetex's shares (NASDAQ:VRTX) gained $1.60, closing at $79.49.

Celsus Therapeutics plc, of New York, reported interim results from the first cohort of its Phase II trial of MRX-6, a non-steroidal, anti-inflammatory cream, for allergic contact dermatitis...These data led to Eleven's Phase Ib clinical study of EBI-005 in subjects with dry eye disease, with top-line data from the Phase Ib study expected in the second half of 2013

Lumena licensed LUM001 from Pfizer Inc., of New York, where the compound was studied as a potential cholesterol-lowering agent...The drug has gone through 12 clinical trials in more than 1,400 subjects already, showing that it knocks down serum bile acid levels safely...Lumena plans to complete the Phase I clinical program of LUM002 in healthy volunteers later this year

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, said results from a prespecified subanalysis of the ARISTOTLE trial were published in Circulation, showing that the reductions in stroke or systemic embolism, number of major bleeding events and mortality demonstrated with Eliqus (apixaban) compared to warfarin were consistent across subgroups defined based on levels of International Normalized Ratio control in patients with nonvalvular atrial fibrillation

Bristol-Myers Squibb Co. (BMS), of New York, disclosed results from a 12-month subgroup analysis of a National Institutes of Health, open-label, long-term research study of metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy (LD...The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining of

NeoStem Inc., of New York, reported the partial exercise of the overallotment option granted to the underwriters to purchase an additional 1.5 million shares of its common stock, at 50 cents per share, in connection with its recent underwritten public offering of 20 million shares of common stock...The exercise of the overallotment option brings the total gross proceeds from the offering to $10.75 million. (See BioWorld Today, May 1, 2013.)

NeoStem Inc., of New York, priced an underwritten public offering of 20 million shares of common stock at 50 cents apiece, seeking to generate $10 million...Scioderm is advancing SD-101, a topical cream with a unique mechanism of action, into clinical development in epidermolysis bullosa (EB), a rare genetic condition that results in extremely fragile skin that blisters and tears easily