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The Verge

FDA approves first treatment for Ebola

The Food and Drug Administration approved a drug tested during the 2018 Ebola epidemic as a treatment for the disease. It’s the first therapy approved by the agency for Ebola, and shows that research done during an emergency can find effective drugs. “Today’s approval highlights the importance of international collaboration in the fight against Ebola virus,” said John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. The drug, called Inmazeb, is a mixture of three antibodies that block the Ebola virus. It was developed by Regeneron, which is also testing an antibody treatment for COVID-19. In clinical trials, patients who took Inmazeb were far less likely to die from the disease. Inmazeb was tested in a clinical trial that ran in 2018 and 2019 during an outbreak of Ebola in the Democratic Republic of the Congo. The trial, called the PALM trial, compared four drugs developed to treat Ebola, and two — this drug and a different antibody cocktail — proved to be the most effective. The PALM trial was the first major attempt to run a rigorous clinical trial during an ongoing disease outbreak. Before it started, the World Health Organization was worried about the downsides of conducting a trial during a emergency, because it could take resources away from caring for sick patients. This trial and other studies done during Ebola outbreaks over the past decade showed that scientific research during an epidemic was possible. Researchers are now applying…Continue readingFDA approves first treatment for Ebola

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Engadget

FDA approves first automated insulin system for kids

The device’s sensor that’s attached to the patient’s body can measure glucose levels under the skin every five minutes. It also comes with a pump and an infusion patch connected to the pump with a catheter to deliver insulin. That means the device will automatically adjust or withhold insulin to regulate the patient’s sugar levels without a caregiver having to do anything at all. However, caregivers still have to manually administer insulin after meals and can’t use the device on children under two years old. FDA Commissioner Stephen M. Hahn, M.D. said in a statement: “Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition/ The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition – which can particularly impact children – is safe and effective.” Despite the FDA’s approval, Medtronic’s work isn’t done. It’s still required to conduct a post-market study evaluating the 770G’s performance in real-world settings. Source linkContinue readingFDA approves first automated insulin system for kids

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The Verge

FDA authorizes Abbott’s fast $5 COVID-19 test

A COVID-19 test that takes 15 minutes and can be run without lab equipment was just granted emergency use authorization by the Food and Drug Administration. It will cost $5, and runs on a simple card that uses the same technology as a pregnancy test. The test, called BinaxNOW, is produced by the health care company Abbott. The company is also launching an app that syncs up with the tests, and gives people who test negative for the virus a “digital health pass” that they can display on their phone. CEO Robert Ford said in a statement that the combination of the test and the app offer a “comprehensive testing solution.” The company said in a press release that it plans to produce 50 million tests per month by October. “Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic,” said Jeff Shuren, director of the FDA Center for Devices and Radiological Health, in a statement. Abbott gets EUA for their lateral flow Covid test. This significant entry could help democratize testing, making more tests more available to people in more austere settings that don’t have all the trappings found in a medical office; including schools. https://t.co/QGOrBmY1pV — Scott Gottlieb, MD (@ScottGottliebMD) August 26, 2020 The test can be used in doctors’ offices, emergency rooms, and even schools, according to the FDA statement. It runs off a…Continue readingFDA authorizes Abbott’s fast $5 COVID-19 test

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The Verge

FDA authorizes convalescent plasma to treat COVID-19

The Food and Drug Administration authorized the emergency use of blood plasma from COVID-19 survivors as a treatment for sick patients. The announcement came after President Donald Trump publicly pressured the agency to speed the development of drugs and vaccines. Plasma should not be the new standard of care for COVID-19, the agency said in a statement. However, it may shorten or reduce the severity of the illness in hospitalized patients. “We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” said commissioner Stephen Hahn in the statement. Preliminary research suggests that the plasma, which contains antibodies against the coronavirus, could help improve the survival rate of people hospitalized with the disease. However, the treatment has only been tested in small groups of COVID-19 patients, and not in the large, placebo-controlled clinical trials that could give clear answers. The agency noted that the evidence supporting the decision to authorize plasma did not come from gold-standard randomized clinical trials in its fact sheet about convalescent plasma for health care workers. “Facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma,” the FDA said in its statement. The FDA had plans to issue an emergency authorization for plasma at the start of August, but put those plans on hold after health officials raised concerns there was not strong enough data supporting the treatment, according to The New York Times. Data from…Continue readingFDA authorizes convalescent plasma to treat COVID-19

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Wired

The FDA Just OK’d Emergency Use of Plasma for Covid-19

In a hastily-called press conference Sunday evening, President Donald Trump and the heads of the Food and Drug Administration and Department of Health and Human Services announced what the president had touted as a “breakthrough” in treating the pandemic disease Covid-19. That breakthrough turned out to be a change in the bureaucratic status of convalescent plasma, a treatment made from the blood of people who have recovered from the disease—treatment that most people can already get, that at least 70,000 people have already received (and probably more like 100,000), and that despite the president’s assurances currently lacks solid evidence for its effectiveness. “It is proven to reduce mortality by 35 percent. It’s a tremendous number,” Trump said at the press conference. “Based on this data, the FDA has made the determination the treatment is safe and very effective.” That last part isn’t actually true yet—without large-scale randomized controlled trials, which haven’t happened yet, no one actually knows that for sure. Yet the agency has issued what’s called an Emergency Use Authorization, not quite an approval of the treatment but still giving the all-clear to physicians who want to administer the frothy, yellow liquid. Based on the president’s comments and those of FDA head Stephen Hahn and HHS director Alex Azar, the data that tipped plasma into getting this Emergency Use Authorization came from a nationwide program to give people wider access to convalescent plasma, led by researchers at the Mayo Clinic. That program was not a large, randomized, controlled clinical…Continue readingThe FDA Just OK’d Emergency Use of Plasma for Covid-19

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The Verge

FDA authorizes COVID-19 saliva test trialed in the NBA bubble

The Food and Drug Administration authorized a saliva-based COVID-19 test that the National Basketball Association helped study. The testing method, called SalivaDirect, is cheap and could be run by most labs. Labs could charge as little as $10 per sample to run the test, said Nathan Grubaugh, an assistant professor at the Yale School of Public Health and one head of the team developing the test, in a press release. This is the fifth saliva-based testing method authorized by the FDA. People can collect a saliva sample themselves by spitting into a tube, rather than have a healthcare provider insert a swab deep into their nasal cavity. Many labs have struggled to get enough swabs for COVID-19 tests, and using saliva sidesteps that bottleneck. The SalivaDirect test also does not use an extra step to pull the coronavirus genetic material out of the saliva sample, so labs don’t need specialized extraction kits — which have also been in short supply. That makes the test slightly less sensitive than other tests, but faster and cheaper. “The SalivaDirect test for rapid detection of SARS-CoV-2 is yet another testing innovation game changer that will reduce the demand for scarce testing resources,” said Brett Giroir, COVID-19 Testing Coordinator, in a press release. The SalivaDirect research was funded in part by the NBA, which also helped the Yale team validate the testing method. The league is playing out the 2020 season inside a “bubble” at Disney World, and the NBA players there are tested for…Continue readingFDA authorizes COVID-19 saliva test trialed in the NBA bubble

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Wired

The FDA Revokes Its Emergency Use Authorization for Hydroxychloroquine

After months of debate and intense research concerning hydroxychloroquine, FDA officials on Monday revoked their Emergency Use Authorization (EUA) for the antimalarial drug that President Donald Trump has promoted in the fight against Covid-19. When the EUA was issued in late March, no high-quality studies of the drug’s ability to prevent and treat Covid-19 were yet available. Now, a handful of randomized trials have failed to find any benefit associated with hydroxychloroquine use. Everything You Need to Know About the Coronavirus Here’s all the WIRED coverage in one place, from how to keep your children entertained to how this outbreak is affecting the economy.  On the basis of the current research, hydroxychloro­quine “may not be effective to treat Covid-19,” and its “potential benefits for such use do not outweigh its known and potential risks” wrote Rear Admiral Denise Hinton, the FDA’s chief scientist, in a letter revoking the EUA. An attached memorandum in support of the agency’s decision cited several recent studies—including one of Covid-19 patients in China and one with US and Canadian participants who had been exposed to the virus—that found no positive effect from hydroxychloroquine use. At the doses permitted under the EUA, FDA officials concluded, hydroxychloroquine is unlikely to help treat or prevent infection from the novel coronavirus. In the absence of an EUA, physicians may still prescribe a drug that has been approved for other purposes, according to their own judgment. Hydroxychloroquine is already FDA-approved to treat lupus, rheumatoid arthritis, and malaria. But the EUA…Continue readingThe FDA Revokes Its Emergency Use Authorization for Hydroxychloroquine

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The Verge

The FDA just approved the first prescription video game — it’s for kids with ADHD

It might not look like much of a video game, but Akili Interactive’s EndeavorRX, formerly Project EVO, may go down in history: it’s the first video game that can legally be marketed and prescribed as medicine in the US. That’s the landmark decision from the Food and Drug Administration (FDA), which is authorizing doctors to prescribe the iPhone and iPad game for kids between ages eight and 12 years old with ADHD, after it underwent seven years of clinical trials that studied over 600 children to figure out whether a game could actually make a difference. According to the company’s favorite of the five studies, the answer is yes: one-third of kids treated “no longer had a measurable attention deficit on at least one measure of objective attention” after playing the obstacle-dodging, target-collecting game for 25 minutes a day, five days a week for four weeks. “Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month,” the company cites, with the most common side effects being frustration and headache — seemingly mild compared to traditional drugs, as you’d hope from so-called virtual medicine. Note: authors of the game’s flagship study may have conflicts of interest That said, we are talking about a study by doctors who work for the game’s developer, according to disclosures at the bottom of the study, and even their conclusion is that the results “are not sufficient to suggest that AKL-T01 should be used as an alternative to…Continue readingThe FDA just approved the first prescription video game — it’s for kids with ADHD

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The Verge

FDA ends emergency authorization for hydroxychloroquine

The Food and Drug Administration is withdrawing emergency authorization for chloroquine and hydroxychloroquine as treatments for COVID-19, the agency announced today. Recent clinical trials showed that the drugs were not effective against the disease. The medications are still FDA-approved for diseases like malaria and lupus, so they remain on the market. Because they are approved for other diseases, doctors could technically still prescribe them for COVID-19 patients under off-label use. Clinical trials focusing on the drugs can also continue. This decision, though, indicates that the FDA is no longer confident that the drug would benefit COVID-19 patients. “We now believe that the suggested dosing regimens for [chloroquine] and [hydroxychloroquine] … are unlikely to produce an antiviral effect,” Denise Hinton, chief scientist at the FDA, said in the announcement. Both drugs have been controversial for months. They were quickly embraced by Brazil’s President Jair Bolsonaro, who pushed for increased production and use of the drugs against the advice of his health officials. In the US, President Donald Trump advocated for their use based on limited evidence, before research showed that it didn’t appear to help patients. The Biomedical Advanced Research and Development Authority faced political pressure to make the drugs available to non-hospitalized COVID-19 patients, despite the lack of evidence to support their use, according to former director Rick Bright. Earlier this month, one major clinical trial of the drug was withdrawn from a scientific journal over concerns about the accuracy of its data. Chloroquine and hydroxychloroquine could have serious side…Continue readingFDA ends emergency authorization for hydroxychloroquine