NEW YORK (Reuters Health)—Subcutaneous golimumab every four weeks provides effective long-term maintenance for patients with active ulcerative colitis (UC), according to results from the PURSUIT-SC extension study. The main PURSUIT-M study showed that golimumab treatment maintained clinical responses through Week 54. For most patients, maintenance therapy for UC is required long term. Dr. Peter R….
Regeneron Pain Drug Clears Late-Stage Trial
(Reuters)—Drugmaker Regeneron Pharmaceuticals Inc. said on Monday its experimental drug to treat moderate to severe osteoarthritis pain was successful in a late-stage study. The drug, fasinumab, was tested on 421 patients with a history of inadequate pain relief or intolerance to current painkillers. Fasinumab binds to nerve growth factor (NGF) proteins and block their activity,…
Careful Collaboration: 5 Tips for Participating in Clinical Trials
For rheumatologists, research is important, but some clinical trials may not be worth collaborating on. In a recent interview, Hermine Brunner, MD, MSc, MBA, FACR, outlined important considerations to make when deciding to participate in a clinical trial to ensure a good fit…
Europe Launches New Fast Approval Scheme for Promising Drugs
LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
No Cause Found Yet for Botched French Drug Trial
PARIS (Reuters)—An initial report into a drug trial in northwestern France that left one person dead and five others hospitalized last month did not identify the exact cause, French Health Minister Marisol Touraine said on Thursday. Touraine told a news conference that the condition of the five people who were hospitalized was improving and that…
Authors Should Share Clinical Trial Data
NEW YORK (Reuters Health)—Authors should agree to share deidentified patient data as a condition for publication of a clinical trial report, according to a proposal from the International Committee of Medical Journal Editors (ICMJE). “Our patients generously and selflessly volunteer to participate in clinical trials on the promise that the knowledge gained will be used…
French ‘Cannabis’ Drug Trial Volunteer Dies
RENNES, France (Reuters)—A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated. The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week. In total, 90 people took part in the trial of the drug made…
French ‘Cannabis’ Drug Trial Leaves 1 Brain Dead, 5 Injured
PARIS (Reuters)—One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in western France of an experimental medicine from an unnamed drug company, the French health ministry said on Friday, Jan. 15. The ministry did not say what the medicine was intended to be used…
NIH-Funded Trials Dip While Industry Trials Are on the Rise
(Reuters Health)—Every year since 2006 in the U.S., the number of clinical trials funded by the National Institutes of Health (NIH) has gone down, while the number of industry-funded trials has gone up, a new study shows. Analyzing the ClinicalTrials.gov database, researchers found that after trial registration became a requirement for publication in major scientific…
Drug Makers Inconsistent in Sharing Clinical Trial Data
(Reuters Health)—Drug companies are inconsistent about disclosing data related to clinical trials of new medicines, a new report says. Researchers examined publicly available data on clinical trials for 15 new medicines from 10 companies that were cleared for sale by the U.S. Food and Drug Administration in 2012. Two of the companies disclosed all trials…