Search Results for: Pharma: Clinical Roundup
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Pharma: Clinic Roundup
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 -
Clinic Roundup
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 -
Pharma: Clinic Roundup
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 -
Pharma: Clinic Roundup
The company said those findings supported the general safety of routine vaccine with HPV4 in a clinical care setting to prevent cervical and other genital and reproductive cancers -
Clinic Roundup
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 -
PCAST to FDA: Double New Drug Output in 10 Years
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 -
Clinic Roundup
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 Makes Splash: Raises $16M, Inks Janssen Deal
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 -
Pharma: Clinic Roundup
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 -
Clinic Roundup
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 -
Clinic Roundup
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 -
Clinic Roundup
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 -
Clinic Roundup
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 -
MAP Seeks $52M, Prepares to Resubmit Levadex NDA
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 -
Clinic Roundup
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 -
Clinic Roundup
Berg Pharma LLC, of Boston, began a Phase I trial of compound 31543 for chemotherapy-induced alopecia...Cerulean Pharma Inc., of Cambridge, Mass., said it dosed the first patient in a Phase II study testing CRLX101 in platinum-resistant ovarian cancer...Results were published online in the Clinical Journal of Pain, ahead of the print edition -
Synageva Rides Stock Crest, Seeks $100M Public Offering
The company is partnered with Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, and recently expanded the collaboration to develop a second protein therapeutic for an undisclosed orphan disease using Synageva's development capabilities and protein expression platform...The company plans to use the proceeds to complete clinical development of lead candidate dalbavancin, currently in a second pivotal Phase III trial in skin infections, and to fund commercialization activities in the U.S...LLC and CRT -
Clinic Roundup
Cerulean Pharma Inc., of Cambridge, Mass., completed enrollment in a Phase II trial of CRLX101, in non-small-cell lung cancer (NSCLC) and dosed its first patient in a Phase Ib/IIa trial of the same product in combination with Avastin (bevacizumab, Roche AG) in metastatic renal cell carcinoma (mRCC...Protalix BioTherapeutics Inc., of Carmiel, Israel, reported clinical data for taliglucerase alfa showing that at 36 months, patients with Gaucher disease had significant improvement in bone marrow fat -
Clinic Roundup
Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said Phase IIa ocular safety results published in the American Journal of Ophthalmology showed that CPP-109 (vigabatrin), a GABA aminotransferase inactivator in clinical trials to treat cocaine addiction, did not cause a decrease in visual acuity or significant peripheral visual field changes with short-term use...Isotechnika Pharma Inc., of Edmonton, Alberta, said 3SBio Inc., of Shenyang, China, received approval in China to begin a -
IPO Window Opening? Tesaro Prices Within Expected Range
The company plans to use the proceeds to fund clinical trials, R&D activities and other corporate programs...Gemmus Pharma Inc., of San Francisco, closed a Series A round to advance its host-targeted treatment for influenza...The company plans to use the proceeds to cover the costs of clinical trials for its product pipeline, including CompleoTRT A bioadhesive intranasal testosterone gel, which is in a Phase III study in hypogonadism, to acquire manufacturing equipment and for other corporate purposes
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