Clinical Trials
The Lead
Companion Diagnostics Keep Drug Development on Schedule
May 1, 2013 4:04 pm | by Sarah Ray, Research Analyst; Cutting Edge Information, Durham, N.C. | Articles | Comments
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.
Pharmacometric Modeling to Support Pediatric Clinical Trials
October 5, 2012 4:17 pm | by Charlene Sanders, MD, Vice President, Global Regulatory Affairs and Pediatric Strategic Consulting; Premier Research Group, Philadelphia | Articles | Comments
With the reissuance of the Product Research and Equity Act, trial sponsors are encouraged to...
FDA, Hemispherx Meet Over Ampligen
July 11, 2012 11:38 am | News | Comments
The U.S. Food and Drug Administration has agreed to review new analyses of data from Hemispherx'...
Trial Design Promises to Accelerate Cancer Drug Approvals
June 3, 2012 11:06 pm | News | Comments
The FDA has drafted a regulatory guidance describing a new way of conducting breast cancer...
Electroporation Key to Skin Cancer Treatment
April 30, 2013 10:56 am | by Punit Dhillon, President and CEO; OncoSec Medical Inc., San Diego, Calif. | Articles | CommentsDespite 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 Heat Shock Protein 90 Inhibitor for Advanced Refractory Solid Tumors
April 12, 2013 10:09 am | by John Lyons, PhD, Vice President, Translational Research and Development; Gavin Choy, PharmD, Vice President, Clinical Sciences and Operations; Amarpal Sahai, Senior Medical Writer; Mohammad Azab, MD, Chief Medical Officer; Astex Pharmaceuticals | Articles | CommentsA 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.
Drug Accountability Software
December 17, 2012 12:22 pm | Product Releases | CommentsPharmaVigilant announced the release of I-Accountability, a drug accountability system that efficiently tracks and controls drug inventory and randomization.
Clinical Trial Registration and Data Disclosure
December 3, 2012 3:53 pm | by John An, PharmD, PhD Manager, Regulatory Affairs, Tracy Farrow Director, Global Medical Writing, Jill Henry, PharmD, Clinical Scientist, Global Product Development, Henrietta Ukwu, MD, Senior Vice President, Global Regulatory Affairs, PPD | Articles | CommentsRegulations—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 Expands Imaging Support for OA Trials
October 16, 2012 4:48 pm | News | CommentsBioClinica 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.
Positive Results from Phase 2 Trial of Oral Calcitonin
October 16, 2012 2:08 pm | News | CommentsTarsa 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.
Widening the Net
October 8, 2012 11:13 am | by Peter A. Bennett, Editor | Articles | CommentsAs 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.
Can We All Just Get Along?
October 4, 2012 3:48 pm | by Nick Conti, PhD, Vice President, Licensing and Strategic Alliances; Quest Diagnostics, Madison, NJ | Articles | CommentsIt 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.
NIH Aims to Improve Large Trials
September 26, 2012 8:58 am | News | CommentsFunds, 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.
Novel Adjuvant Treatment for Early-Stage Breast Cancer
September 18, 2012 3:53 pm | by Rosemary Mazanet, MD, PhD, Executive Vice President and Chief Medical Officer; Mark J. Ahn, PhD, President and Chief Executive Officer; Galena Biopharma, Lake Oswego, Ore. | Articles | CommentsWhile 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.
Taking the 505(b)(2) Route
August 9, 2012 3:59 pm | by Kenneth V. Phelps, President and CEO; Camargo Pharmaceutical Services, Cincinnati | Articles | CommentsIt’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.
Evaluating Rilotumumab in Patients with Gastric and Esophageal Cancer
August 9, 2012 3:42 pm | by David Chang, MD, PhD, Vice President, Global Oncology Development; Amgen, Thousand Oaks, Calif. | Articles | CommentsGastric 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 Partners with ClinPlan
July 19, 2012 11:55 am | News | CommentsBioClinica Inc. has partnered with ClinPlan LLC to deliver clinical supply simulation services in conjunction with BioClinica Optimizer.
BI-204 Fails to Meet Study Goals
July 17, 2012 11:29 am | News | CommentsBioInvent International AB announced data from the GLACIER Phase 2a clinical trial evaluating BI-204 in patients with stable atherosclerotic vascular disease.
Positive Data from Late-Stage Dolutegravir Study
July 17, 2012 11:25 am | News | CommentsShionogi-ViiV Healthcare LLC announced initial results from a Phase 3 study of the integrase inhibitor dolutegravir in treatment-naïve adults with HIV-1.
Positive Results from TD-1211 Study
July 16, 2012 11:29 am | News | CommentsTheravance Inc. announced results from a Phase 2b trial evaluating TD-1211 as a treatment for chronic, non-cancer pain patients with opioid-induced constipation.
FDA Places Hold on Hemophilia Trials
July 13, 2012 11:06 am | News | CommentsThe Food and Drug Administration has notified Inspiration Biopharmaceuticals that both clinical trials evaluating IB1001 were placed on clinical hold.
Verona Starts COPD Trial
July 13, 2012 11:00 am | News | CommentsVerona 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 Ends Odanacatib Study Early
July 12, 2012 10:41 am | News | CommentsMerck & 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.
Key Alzheimer Study Results Coming
July 12, 2012 10:36 am | by Marilynn Marchione | News | CommentsResults 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.
Lilly Schizophrenia Drug Fails Study
July 11, 2012 11:26 am | News | CommentsEli Lilly announced negative clinical trial results from a study investigating pomaglumetad methionil for the treatment of patients suffering from schizophrenia.
First CRLX101 Patient Dosed
July 10, 2012 11:14 am | News | CommentsCerulean 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.
Xerecept Reduces Need for Steroids
July 10, 2012 11:05 am | News | CommentsRecently presented data showed encouraging positive results from a Phase 1/2 study of Xerecept in pediatric patients with peritumoral cerebral edema.
PA401 Trial Opens in the UK
July 9, 2012 11:06 am | News | CommentsProtAffin AG has started dosing healthy volunteers in a Phase 1 clinical study in the UK with its novel investigational anti-inflammatory product, PA401.
Momenta Begins Pancreatic Cancer Trial
July 9, 2012 11:01 am | News | CommentsMomenta Pharmaceuticals has begun dosing in a Phase 1/2 clinical trial of M402 with gemcitabine in patients with advanced metastatic pancreatic cancer.
