According to its president, Ronald DePinho, MD Anderson is focused on improving the execution of clinical trials by interacting with the entire "ecosystem" of drug development, with an emphasis on engaging participants proactively and putting patients at the center...If academic organizations were to conduct post-mortems on why clinical trials fail, "a good amount of that is that we're not doing a good enough job at the preclinical level to mature the concept to a point where the private sector can

When it comes to biopharma, the development cost for one drug can be hundreds of millions of dollars, depending on the number and size of clinical trials the FDA requires

The number of clinical trials will be different...III clinical trials, and you need to do at least 300 cases

Stratification of patients enables efficient and economic clinical trials that are run faster, at a smaller size and with lower attrition rates...Blinded Diagnostics LLC, of Saddle Brook, N.J., provides same-day lab results for clinical trials and compiles them electronically

Reddy's said it intended to market Reditux in other regions, including the U.S., upon patent expiry, which is set to occur in Europe this year and in 2018 in the U.S. However, the Hyderabad, India-based company has yet to begin clinical development in either the European Union (EU) or the U.S., according to clinical trial registries. (See BioWorld Today, Jan. 6, 2011.) Given its market size, Rituxan/MabThera, developed by Roche AG and partnered with Biogen Idec Inc., is a prime target for

Clinical trials marking progress toward a broad-acting, all-oral regimen for treating hepatitis C were reported in The New England Journal of Medicine and at the International Liver Congress of the European Association for the Study of the Liver (EASL) in Amsterdam, the Netherlands, this week...Inc., of Whitehouse Station, N.J., reported interim data from a Phase II, multicenter, randomized, dose-ranging clinical trial evaluating the safety and antiviral activity of MK-5172 for the treatment of

According to the Pharmaceutical Research and Manufacturers of America (PhRMA), last year biopharmaceutical research companies had approximately 460 medicines targeting rare diseases either in clinical trials or awaiting FDA review. (See BioWorld Insight, Oct 15, 2012.) Interest in drug development targeting orphan disease indications continues to heat up

Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology data

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

The number of clinical trials will be different...III clinical trials, and you need to do at least 300 cases

Galapagos plans to initiate preclinical studies in order to enter the first clinical trials within a year...Net proceeds will be used to complete a Phase II Squalamine eye drop clinical trial for the wet form of age-related macular degeneration, to further the clinical development of the eye drops for the treatment of other neovascular ophthalmic disorders, to fund development of other pipeline molecules, and for general corporate purposes

The number of clinical trials will be different...III clinical trials, and you need to do at least 300 cases

Reddy's said it intended to market Reditux in other regions, including the U.S., upon patent expiry, which is set to occur in Europe this year and in 2018 in the U.S. However, the Hyderabad, India-based company has yet to begin clinical development in either the European Union (EU) or the U.S., according to clinical trial registries. (See BioWorld Today, Jan. 6, 2011.) Given its market size, Rituxan/MabThera, developed by Roche AG and partnered with Biogen Idec Inc., is a prime target for

Ltd. (Seoul, South Korea) ND Agreement to develop and commercialize multiple pre-specified and undisclosed biosimilar candidates Samsung will be responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration

it involves five cancer targets from AstraZeneca 12/12/12 Myriad Genetics Inc. (Salt Lake City) Sanofi SA (Paris) and Population Health Research Institute at Hamilton Health Sciences and McMaster University (Canada) ND Research collaboration with Myriad's subsidiary, Myriad RBM, to perform protein biomarker research for the Outcome Reduction with Initial Glargine Intervention (ORIGIN) study, a clinical trial in pre- and early diabetes Myriad RBM will analyze more than 8,000 serum samples

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 dementia

The need to treat quickly makes it difficult to get informed consent for a clinical trial

The EU Clinical Trials Register merely described the study, which was comparing Celltrion's CT-P10 to MabThera in patients with advanced follicular lymphoma at European trial sites, as "prematurely ended

I do have some safety concerns about this particular therapy, because I believe the toxicity over a long period of time is going to cause continued exacerbations, as it did in the clinical trials," Mullins said