Fda approves zephyr endobronchial valve for treating severe emphysema

Share to Twitter Share to Linkedin Topline The Food and Drug Administration on Monday declined to authorize a cheap and widely available antidepressant as a treatment for Covid-19, finding that a study indicating the drug was effective against the disease was severely limited. Key Facts Fluvoxamine maleate —which is used to treat depression, obsessive-compulsive disorder and other conditions—also has anti-inflammatory properties, making it a possible treatment for Covid-19, which apparently inflicts many of its symptoms through inflammation . The request for an FDA emergency use authorization for fluvoxamine was based mainly on a preliminary study published in January by the Lancet , which indicated that the drug reduced chances of hospitalization or six-hour emergency care visits by 32% among patients at heightened risk of severe Covid-19. However, in a rare statement Monday explaining its decision to reject the … [Read more...] about FDA Rejects Bid To Authorize Cheap Antidepressant As Covid Treatment

Share to Twitter Share to Linkedin The Food and Drug Administration denied an emergency use authorization for fluvoxamine as a SARS-CoV-2 antiviral. Fluvoxamine was proposed as a possible antiviral in 2021 due to its mechanisms of action for treating obsessive-compulsive disorder. These same mechanisms were suspected to inhibit SARS-CoV-2, leading to four trials testing the efficacy of the drug. In December 2021, Dr. David R Boulware requested an emergency use authorization for the outpatient treatment of adults testing positive for SARS-CoV-2 to prevent progression to severe symptoms based on early efficacy data from the fluvoxamine trials. The Food and Drug Administration denied his request, listing concerns such as insufficient data. Here we will discuss the FDA’s decision and reasoning. Trials The FDA’s main concern was the lack of conclusive evidence from four trials that were below emergency use authorization standards. The largest of … [Read more...] about FDA Turns Down Fluvoxamine Emergency Use Authorization Request

advertisement advertisement Kristine sat in a reclining chair, cocooned in an eyeshade and headphones, with a weighted blanket covering her lap. Incense burned in the background. She felt a pinch in her arm. “Okay,” the nurse said. “Have a nice trip!” Kristine peeled back her eye mask. “How long does it take to kick in?” she asked. “About 45 to 60 seconds,” the nurse said. advertisement advertisement “Okay, then. I’ll see you later,” Kristine said, bringing the mask back down and letting the ketamine take effect. Kristine’s 45-minute-long ketamine trip, which took place last May at a clinic in New York City, is part of a new approach to mental health care, one that employs once-verboten psychedelic drugs. For decades, a privileged few researchers have been charting the success of drugs like MDMA (known in clubs as Molly or ecstasy), LSD (acid), psilocybin (“magic mushrooms”), and ketamine (“Special K”) in treating depression, … [Read more...] about Psychedelic companies are betting big on ketamine as the next Prozac

Cardiologists have long been confounded by a particular problem in treating patients with buildups of hard calcium—a condition that can shrink and stiffen their blood vessels. In the past, operating on those with calcified buildups often meant risky and difficult procedures. advertisement Those dangers may be a thing of the past. A revolutionary process developed by medical device company Shockwave Medical utilizes sound waves generated from inside the blood vessels themselves to break up calcium deposits. The new treatment—safer and more effective than traditional methods—earned Shockwave a place on Fast Company’s list of the world’s Most Innovative Companies. “Shockwave makes treating a calcified vessel very similar to treating an uncalcified vessel in terms of risks and outcomes,” says Doug Godshall, president and CEO of Shockwave. “The kinds of complications seen with other approaches are essentially nonexistent with ours.” A BETTER WAY TO BREAK UP CALCIUM … [Read more...] about When sound saves lives

Psychedelics, long stigmatized as risky recreational drugs, are finally finding a place in polite society. More and more research from prominent institutions like Johns Hopkins suggests that such drugs, in the right formulations and with supervision, can bring about therapeutic breakthroughs in patients, notably in those who have proven to be resistant to other types of treatment. advertisement advertisement Venture capital firms have taken notice—pouring money into startups developing psychedelic treatments for everything from PTSD to smoking cessation. A January analysis by Business Insider identified 11 venture capital firms (most of them founded in the past three years) that have collectively invested roughly $140 million in the psychedelics category. Funding accelerated after psychedelic startup Compass Pathways raised $146 million in its September 2020 initial public offering and an additional $144 million in a secondary offering in April … [Read more...] about VC money keeps flowing into psychedelics-based mental health

An image created during an investigation into an outbreak of monkeypox, which took place in the Democratic Republic of the Congo (DRC), 1996 to 1997, shows the hands of a patient with a rash due to monkeypox, in this undated image obtained by Reuters on May 18, 2022. The rare monkeypox virus, usually confined mostly to Central and West Africa, has spread in unusual ways this year and among populations that have not been vulnerable in the past. But while the transmissions have created some alarm among officials and infectious disease experts, and while a Covid-19-weary world is on high alert for new outbreaks, there are several reasons monkeypox is not being treated with the same level of concern as the coronavirus. Here is what to know about monkeypox and the risks it poses. - What is monkeypox? - Monkeypox is a virus endemic in parts of Central and West Africa. It is a more benign version of smallpox. It was discovered in 1958, after outbreaks occurred in monkeys kept … [Read more...] about Monkeypox: A rare virus on the rise