Companion diagnostic tools allow companies to increase their chances of drug approval by targeting the right patients early. Developing the strategy, timing, and resources necessary for companion diagnostics success begins with understanding the mechanisms that successful companies use to build their programs.
With the reissuance of the Product Research and Equity Act, trial sponsors are encouraged to...
The U.S. Food and Drug Administration has agreed to review new analyses of data from Hemispherx'...
The FDA has drafted a regulatory guidance describing a new way of conducting breast cancer...
Despite advances that have been made in sunscreen technology and growing public awareness of the need for sunscreen, recent data have found that the average U.S. lifetime risk of invasive melanoma has increased from 1 in 600 in 1960 to 1 in 50 in 2008.
A key function of heat shock proteins (HSPs) is to act as molecular chaperones to assist in the folding and stabilization of numerous client proteins. One family of HSPs—heat shock protein 90—stabilizes a diverse range of client proteins, many of which are involved in key pathways in malignancy.
PharmaVigilant announced the release of I-Accountability, a drug accountability system that efficiently tracks and controls drug inventory and randomization.
Regulations—such as clinical trial registration and public disclosure of results—were developed to restore public trust in the industry while improving healthcare through increased transparency and decreased information selection or bias.
BioClinica Inc. has expanded its imaging services for clinical trials in the area of osteoarthritis (OA), a disease affecting over 21 million people in the United States. developing a device to correctly position patients to measure small changes on film rediographs.
Tarsa Therapeutics Inc. announced that a Phase 2 trial of its oral recombinant salmon calcitonin in the prevention of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, clinically relevant improvements in bone mineral density (BMD) at the lumbar spine.
As pharma tries to rebuild from the revenue losses incurred during the patent cliff, it becomes clear that the after-effects will be felt for a long time. Pharmaceutical and biotech executives have pointed to rising costs and diminishing returns as a sign that the old model simply doesn’t apply anymore.
It has become abundantly clear that personalized medicine will play an increasingly important role in the evolution of drug development and delivery. Treatments targeted to the needs of the individual patient have the potential for far greater clinical and economic payoffs than the traditional one-size-fits-all approach.
Funds, totaling approximately $11.3 million, will support the first year of the Health Care Systems (HCS) Research Collaboratory, which will engage health care systems as research partners in conducting large-scale clinical studies. The funds are managed through the Common Fund at the National Institutes of Health.
While improved diagnostics and targeted therapies have decreased breast cancer mortality in the United States, metastatic breast cancer remains incurable. Up to 25% of resectable node-positive breast cancer patients will relapse within three years following diagnosis.
It’s no secret that drug development is a challenging way to make a profit. For every blockbuster compound with broad demographic application like Lipitor, thousands of once-promising compounds wash out in the preclinical phase and hundreds more fail in clinical trials.
Gastric cancer is the second most common cause of cancer-related death in the world. It accounted for 736,000 deaths worldwide in 2008, with the highest mortality rates being observed in Eastern Asia. An estimated 21,320 new cases of gastric cancer will be diagnosed in the United States in 2012, and about 10,540 Americans will die from the disease this year.
BioClinica Inc. has partnered with ClinPlan LLC to deliver clinical supply simulation services in conjunction with BioClinica Optimizer.
BioInvent International AB announced data from the GLACIER Phase 2a clinical trial evaluating BI-204 in patients with stable atherosclerotic vascular disease.
Shionogi-ViiV Healthcare LLC announced initial results from a Phase 3 study of the integrase inhibitor dolutegravir in treatment-naïve adults with HIV-1.
Theravance Inc. announced results from a Phase 2b trial evaluating TD-1211 as a treatment for chronic, non-cancer pain patients with opioid-induced constipation.
The Food and Drug Administration has notified Inspiration Biopharmaceuticals that both clinical trials evaluating IB1001 were placed on clinical hold.
Verona Pharma plc has commenced a new trial designed to test the anti-inflammatory properties lead drug candidate, the dual PDE 3 and 4 inhibitor, RPL554.
Merck & Co. said that it is ending a late-stage clinical trial of its osteoporosis drug odanacatib because there was clear evidence the experimental drug was working.
Results from several key Alzheimer's disease studies are due within a month or so for two drugs, with data from a third expected later in the year.
Eli Lilly announced negative clinical trial results from a study investigating pomaglumetad methionil for the treatment of patients suffering from schizophrenia.
Cerulean Pharma Inc. has dosed the first patient in a Phase 1b/2a study of CRLX101, in combination with Avastin, in metastatic renal cell carcinoma patients.
Recently presented data showed encouraging positive results from a Phase 1/2 study of Xerecept in pediatric patients with peritumoral cerebral edema.
ProtAffin AG has started dosing healthy volunteers in a Phase 1 clinical study in the UK with its novel investigational anti-inflammatory product, PA401.