Search Results for: Clinical Roundup
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Clinic Roundup
Acelrx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data that showed its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met the primary and secondary efficacy endpoints in a placebo-controlled, Phase III study...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 twoBioWorld Today | Thursday, May 23, 2013 -
Ambit Cuts Price, Ups Shares; $65M IPO to Fund Quizartinib
Top-line data are expected by the end of 2014...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for additional territoriesBy Jennifer Boggs | BioWorld Today | Friday, May 17, 2013 -
Receptos Prices Solid IPO, Raises $72.8M for Pipeline
The funds will support clinical work in multiple sclerosis (MS), inflammatory bowel disease (IBD) and allergic/immune-mediated disorders. (See BioWorld Today, April 8, 2013.) The pricing hits pretty close to the $86.3 million target set when the company filed for its offering only a month ago...RPC1063 is undergoing a Phase II/III study (RADIANCE) in relapsing MS patients, with top-line data from the Phase II portion expected in mid-2014...Chardan Capital Markets LLC acted as exclusive placementBy Catherine Shaffer | BioWorld Today | Friday, May 10, 2013 -
Clinic Roundup
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 2013BioWorld Today | Thursday, May 9, 2013 -
Clinic Roundup
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 sialorrhea...The study will include 20 subjects, and top-line data are expected by year-endBioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
Top-line data are expected in the fourth quarter...Ltd., of Germantown, Md., said it filed an investigational new drug application (IND) to begin clinical trials of its adipose-derived stem cell product, RNL-JointStem, for the treatment of osteoarthritisBioWorld Today | Friday, May 3, 2013 -
Clinic Roundup
Ceregene Inc., of San Diego, reported top-line data from its double-blind, randomized, controlled Phase IIb study of CERE-120 (AAV-neurturin), a gene therapy designed to deliver the neurotrophic factor neurturin, for Parkinson's disease...Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said the Journal of Nuclear Medicine published the results from a clinical trial of NAV4694 in healthy subjects and those with diagnosed forms of dementiaBioWorld Today | Monday, April 22, 2013 -
Clinic Roundup
Alkermes Inc., of Dublin, Ireland, said top-line data from a Phase II study showed that ALKS 5461, a drug in development to treat patients who have an inadequate response to standard therapies for clinical depression, significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measure, the Hamilton Depression Rating Scale (p = 0.026), the Montgomery-Asberg Depression Scale (p = 0.004) and the Clinical Global Impression-Severity Scale (pBioWorld Today | Thursday, April 18, 2013 -
IPO Flurry Continues: Receptos Files Proposed $86M Offering
RPC1063 is in an accelerated design Phase II/III study, dubbed RADIANCE, in relapsing MS patients, with top-line data from the Phase II portion expected in mid-2014...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 other general corporate purposes...Shares of MEI (NASDAQ:MEIP) closed Friday at $8.35, up 6 cents.By Jennifer Boggs | BioWorld Today | Monday, April 8, 2013 -
Clinic Roundup
Novavax Inc., of Rockville, Md., said top-line data from its Phase II dose-ranging study testing its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age hit its protocol-specified objectives, supporting progression to the next stage of advanced clinical testingBioWorld Today | Thursday, April 4, 2013 -
Clinic Roundup
Auxilium Pharmaceuticals Inc., of Chesterbrook, Pa., reported positive top-line data from a Phase IIa trial of Xiaflex (collagenase clostridium histolyticum, or CCH) in adhesive capsulitis, commonly known as frozen shoulder syndrome (FSS...dosage form of either tedizolid or linezolid with the option to switch to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day of treatmentBioWorld Today | Tuesday, March 26, 2013 -
Clinic Roundup
In conjunction with the changes in its clinical program, the company said it reduced its work force by 50 percent and outsourced noncritical research and development functions...Top-line data from the RA study are expected midyearBioWorld Today | Wednesday, February 27, 2013 -
Immunomedics Seeks $14M as Bridge to Milestones
UCB also picked up clinical development and commercialization costs. (See BioWorld Today, May 11, 2006.) In 2009, the companies reported results from a Phase IIb dosing study of the drug showing a 24.9 percent treatment advantage over placebo in systemic lupus erythematosus (SLE) patients...Those global registration trials are continuing, and UCB expects to report top-line data in the first half of 2014, according to Cheng...Oxygen plans to use proceeds from the offering to continue clinical trialsBy Marie Powers | BioWorld Today | Monday, February 25, 2013 -
Clinic Roundup
The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response...Top-line data are expected during the second half of this yearBioWorld Today | Wednesday, February 20, 2013 -
Clinic Roundup
The goal of the trial will be first to find optimum dosing of the drug, and second to assess safety, pharmacokinetics, pharmacodynamics and clinical activity in disease-specific cohorts of at least 12 patients each...Vanda Pharmaceuticals Inc., of Washington, said top-line data from its Phase IIb/III study, dubbed MAGELLAN, testing tasimelteon as a monotherapy in major depressive disorder (MDD) did not meet the primary endpoint of change from baseline in the Hamilton Depression Scale after eightBioWorld Today | Friday, February 1, 2013 -
Clinic Roundup
Top-line data are expected in the first half of 2014...Stratatech Corp., of Madison, Wis., reported top-line data from a proof-of-concept trial testing StrataGraft, a universal human skin substitute in development for treating severe burnsBioWorld Today | Thursday, January 17, 2013 -
Clinic Roundup
Top-line data revealed that at the early clinical evaluation point, between 48 hours and 72 hours of treatment initiation, 90.9 percent of subjects were considered to be stable or improving in investigator assessments, meeting the primary endpoint of the studyBioWorld Today | Tuesday, January 8, 2013 -
Clinic Roundup
As initially reported in December, preliminary top-line data showed that dalbavancin achieved its primary endpoint of noninferiority at 48 to 72 hours following initiation of therapy, as determined by the cessation of spread of the lesion and resolution of fever...Durata said the secondary endpoint of clinical success at the end of treatment – the expected primary endpoint for regulatory review in Europe – also was metBioWorld Today | Monday, January 7, 2013 -
Clinic Roundup
Top-line data are expected in the early spring of 2013...The company is trying to reduce the cost of clinical trials by 50 percent or more, and is partnered with Advanced Monitored Caregiving, a telehealth provider, to that endBioWorld Today | Wednesday, December 19, 2012 -
Clinic Roundup
The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses...Top-line data are expected in the latter part of next yearBioWorld Today | Tuesday, December 18, 2012
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