Patients don't benefit from this type of approach." – Carlo Toniatti, head of research at the Institute for Applied Cancer Science and the Center for Co-Clinical Trials at the University of Texas MD Anderson Cancer Center, discussing improved clinical success rates for cancer drugs identified by the Tufts Center for the Study of Drug Development "It's been a long time since we did a public financing – 12 or 13 years – and we've managed through by being cautious in how we spend our cash and by
Net proceeds are expected to total about $16.1 million and will be used for general corporate purposes, including expenses related to the potential commercialization of OMS302 for intraocular lens replacement, as well as for R&D expenses such as clinical trials of its OMS103HP, PDE10, MASP-2 and PDE7 programs
There may be value in discussing the benefit-risk framework at end-of-Phase II meetings, in order to ensure alignment on identified and potential risks and benefits, critical efficacy and safety assessments, and risk mitigation strategies in Phase III clinical trials," PhRMA noted
By Mari Serebrov | BioWorld Today | Friday, May 10, 2013
Eventually, it could be used to find research centers, staffing talent and other resources needed to conduct a pediatric clinical trial in a specific region...To get FDA authorization to charge for an investigative drug or for an unapproved use of an approved drug in a clinical trial, a sponsor must demonstrate that the drug has a potential clinical benefit that would be a significant advantage over available therapies
By Mari Serebrov | BioWorld Today | Thursday, May 9, 2013
GSK is a research partner of CluePoints Inc., a Cambridge, Mass.-based company Busye founded to develop an automated system for statistical monitoring of clinical trial data
By Cormac Sheridan | BioWorld International | Wednesday, May 8, 2013
The study, dubbed Gammaglobulin Alzheimer's Partnership, was conducted in collaboration with the Alzheimer's Disease Cooperative Study, a clinical trial consortium supported by the National Institute on Aging
Success rates doubled for cancer drugs that entered clinical trials in the early 1990s and those that entered the clinic a decade later, even as the number of such compounds increased by 50 percent over the period, according to a new analysis by the Tufts Center for the Study of Drug Development (CSDD...However, small molecules dominated as a percentage of cancer drugs entering clinical trials, representing 73 percent of compounds during 1993 to 1998 and 71 percent in 1999 to 2004
By Marie Powers | BioWorld Today | Wednesday, May 8, 2013
CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion...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
shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infection
By Jennifer Boggs | BioWorld Today | Tuesday, May 7, 2013
clinical trials where a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs
classification, which may have a direct effect on treatment recommendations for patients, and provides opportunities for genome-guided clinical trials and drug development
filings, Merck's Canadian subsidiary transferred sponsorship of all vernakalant clinical trial applications to Cardiome...It outlines current scientific knowledge about the mechanistic basis of adaptive coronary collateral growth, the biological processes to be targeted by therapeutic angiogenesis and the optimization of clinical trial designs, including the selection of appropriate clinical trial endpoints, selection of patients who are likely responders to therapeutic stimulation of collateral
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 osteoarthritis
Bionomics Ltd., of Adelaide, South Australia, initiated manufacturing activities at Lonza Group Ltd.'s facility in Slough, UK, to enter BNC101 into clinical trials following completion of key preclinical studies...Bionomics hopes to begin clinical trials in 2014
FDA approval was based on a new drug application comprising data from six clinical trials, including a randomized, multicenter, active-controlled Phase III trial of 43 patients with NC and extension data from that trial
By Marie Powers | BioWorld Today | Wednesday, May 1, 2013
Patients don't benefit from this type of approach." – Carlo Toniatti, head of research at the Institute for Applied Cancer Science and the Center for Co-Clinical Trials at the University of Texas MD Anderson Cancer Center, discussing improved clinical success rates for cancer drugs identified by the Tufts Center for the Study of Drug Development "It's been a long time since we did a public financing – 12 or 13 years – and we've managed through by being cautious in how we spend our cash and by