Noting a trend for pharma companies to engage in more collaborations and acquisitions in order to supplement their pipelines with new technology, Lammers said he could envision such an outcome for Mirna...Given the interest of big pharma in microRNA companies, including Mirna, I'm convinced if we have strong human proof-of-concept data in the clinic, most likely pharma will be interested in stepping up to the plate," Lammers said

Investigators said 47 percent of patients receiving Simponi 50 mg and 51 percent of patients receiving Simponi 100 mg maintained clinical response through week 54 compared with 31 percent of patients on placebo (p = 0.01 and p < 0.001, respectively...Investigators will report clinical response, clinical remission and mucosal healing results through one year at the American College of Gastroenterology meeting in Las Vegas

Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index

Alexion Pharmaceuticals Inc., of Cheshire, Conn., said researchers presented data from an open-label Phase II study in 14 patients with severe, relapsing neuromyelitis optica (NMO), showing that Soliris (eculizumab) met its primary endpoint with high degrees of clinical and statistical significance...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 clinical effects

Additional results from the PHOENIX-2 study showed that high levels of clinical responses were achieved and maintained with up to five years of ustekinumab treatment

The trial will have two stages: The first stage will treat patients with escalating doses of SGI-100 and carboplatin to identify the maximum-tolerated dose and preliminary biological and clinical activity, while the second stage will randomize patients to receive SGI-100 plus carboplatin or one of three treatments of choice as determined by the clinical investigator – toptecan, pegylated liposomal doxorubicin or paclitaxel...Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi SA, of

Clinical trials now represent an aggregate expense of approximately $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...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

Proceeds will be used to fund ACT's clinical activities, including its three ongoing Phase I/II trials for forms of macular degeneration, for development of its other clinical activities and for general corporate purposes...Horizon Pharma Inc., of Deerfield, Ill., priced an underwritten public offering of 21.42 million units, with each unit consisting of one share of its common stock and a warrant to purchase a half share of its common stock...Royalty Pharma has invested $25 million under its royalty

The company said the financing will enable them to complete a clinical study to confirm the positive treatment effects of Oxabact previously seen in patients with primary hyperoxaluria, a rare inborn autosomal genetic disorder leading to markedly elevated levels of endogenous oxalate in plasma and urine...Tranzyme Pharma Inc., of Research Triangle Park, N.C., said it closed a registered direct offering of approximately 3 million shares of its common stock at $3.85 per share for gross proceeds

Pluristem's platform already has captured the attention of pharma...Proceeds will be used to support clinical studies, R&D activities and for general corporate purposes, including working capital and administrative expenses...Neuralstem Inc., of Rockville, Md., priced a registered direct offering of 7 million shares at $1 apiece for gross proceeds of $7 million to support working capital, capital expenditures, R&D activities, clinical trials and acquisitions of new technologies or businesses

The study is designed to assess the clinical impact of the absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogues...Glenmark's partner, Paris-based Sanofi SA, has licensed all rights to the drug and is carrying out clinical development...Zealand Pharma A/S, of Copenhagen, Denmark, said it dosed the first patient in a Phase I study of ZP2929, a dual-acting glucagon/GLP-1 peptide agonist, in development for treating patients with Type II diabetes and/or patients with

Vascular Pharma will receive an up-front payment and milestone payments in exchange for the acquisition rights...Vascular Pharma expects its funding to last through completion of Phase II, getting the company to the point where Janssen may exercise its option...Pharma giants Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, have thrown their hats into the ring, as well

Sanofi Pasteur, of Lyon, France, the vaccines division of Sanofi SA, said clinical results published in The Lancet showed the ability of its vaccine candidate to protect against dengue fever caused by three dengue virus types

Eaton Scientific Solutions Ltd., of Beverly Hills, Calif., a subsidiary of Pristine Solutions Inc., said it is finalizing preparations for a clinical program testing Tropine 3, which contains FDA-approved anticholinergic drug Homatropine, in an oral suspension...Proacta Inc., of San Diego, said the FDA cleared its investigational new drug application for clinical testing of PR610, a hypoxia-activated, irreversible multikinase inhibitor aimed at treating cancer...The first clinical study, to be

If approved, the product, indicated for the treatment of autoimmune and inflammatory diseases, will enter clinical trials...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, published Phase III results from the AFFIRM trial of enzalutamide (MDV3100) in metastatic castration-resistant prostate cancer patients previously treated with docetaxel-based chemotherapy in the New England Journal of Medicine...clinical development of agomelatine for autism and pain

Meritage Pharma Inc., of San Diego, began a Phase II trial of oral budesonide suspension for eosinophilic esophagitis...The trial will be carried out at clinical centers in the U.S

Agenus Inc., of Lexington, Mass., said clinical data from a Phase I trial of a Prophage Series vaccine (HSPPC-96, vitespen) to treat patients with recurrent glioblastoma multiforme (GBM) were published online by Clinical Cancer Research...Clavis Pharma ASA, of Oslo, Norway, said its partner Clovis Oncology Inc., of Boulder, Colo., initiated a Phase I study of CP-4126 (CO-101) in combination with cisplatin in non-small-cell lung cancer (NSCLC

The FDA did not cite clinical safety or efficacy issues and did not request additional pre-approval studies, but the agency did raise questions relating to chemistry, manufacturing and controls, as well as issues related to a facility inspection at a third-party manufacturer. (See BioWorld Today, March 28, 2012.) The company completed an end-of-review meeting with the FDA in June to seek clarity from the agency in developing its response...Horizon Pharma Inc., of Deerfield, Ill., filed an S3 shelf

BHR Pharma LLC, of Phoenix, said it reached its SyNAPSe clinical trial enrollment midpoint of 590 patients...ICT-121 is the second dendritic-cell-based vaccine to enter clinical trials