A Minneapolis hospital tested powerful antipsychotics and the potent anesthetic ketamine on emergency room patients without their knowledge or consent, violating regulations on human research, federal inspectors have determined. Based on those findings, a health watchdog group on Monday urged federal regulators to suspend all clinical trials at the hospital. In a letter to the Food and Drug Administration and the Department of Health and Human Services office that protects...
Tag: <span>FDA</span>
Post
FDA approves magnetic brain-zapping helmet to treat OCD sufferers who don’t respond to therapy or drugs
Over two percent of the population develops obsessive-compulsive disorder at some point over the course of their lives Repetitive thoughts, compulsions, and behaviors can disrupt these peoples’ lives and isolate them OCD is characterized by an overly-active brain circuit Transcranial magnetic stimulation uses magnetic pulses to disrupt the electrical activity in this circuit A similar...
Post
Bladder control via gene therapy?
What are the limits of gene therapy? “There are no currently available FDA-approved gene therapy treatments for overactive bladder,” reads this press release. And that’s true. But is it, like, a problem? Urovant Sciences believes so, which is why it licensed just such a gene therapy for overactive bladder. It’s called hMaxi-K, and it targets...
Post
Cancer drug earns FDA nod after decades
Duncan Hunter chokes up a little when it is suggested that work he began at Western three decades ago will now, finally, be applied to saving hundreds of lives. “It’s a good thing,” said the Chemistry professor emeritus after a long pause. “It took 30 years and had its ups and downs. So, yes, it’s...
Post
FDA grants first approval for CA drug under new pilot programs
(HealthDay)—The U.S. Food and Drug Administration has approved Ribociclib (Kisqali) in combination with an aromatase inhibitor (AI) as an initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib has also been approved with fulvestrant as initial...
Post
How to spot phony clinical trials
Want to get rid of your herpes? Get this vaccine. That’s what convinced participants on the Caribbean island of St. Kitts and in the state of Illinois to enter a series of research trials, run by a Southern Illinois University (SIU) professor. Between 2013 and 2016, more than two dozen people received the experimental treatment....