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The Food and Drug Administration approved on Wednesday a treatment for the Ebola virus. This is the first FDA-approved treatment for Zaire ebolavirus infection in adults and kids.Zaire ebolavirus is one of four Ebola virus species that can cause potentially deadly infections. It is transmitted through direct contact with blood, tissue or body fluids of an infected person or wild animal.The treatment, Inmazeb, is a mixture of three monoclonal antibodies and was created by Regeneron Pharmaceuticals. The three antibodies work together to bind to the glycoprotein on the surface of the Ebola virus and block it from entry into the body’s cells.Inmazeb was tested in the Democratic Republic of the Congo during an Ebola virus outbreak in 2018-2019 through a partnership between the local government and the National Institutes of Health.A vaccine for Ebola virus was approved by the FDA in December 2019.Regeneron is also the company behind an experimental antibody cocktail that was given to President Donald Trump following his diagnosis of COVID-19, and which he said “cured” him. Trump was also prescribed the antiviral drug remdesivir and the steroid dexamethasone at the time.Regeneron’s COVID-19 treatment is a mix of two powerful antibodies that are believed to boost the immune response to the coronavirus. Early results seem promising, according to initial tests and a press release from the company.The company has submitted an application to the FDA to get emergency approval of their COVID-19 treatment. 1525
The FDA warned the public on Thursday to not use hand sanitizers packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.The FDA said that some products are being packaged in items such as water bottles and food pouches, and may contain flavors such as chocolate or raspberry. The FDA said that ingesting alcohol-based hand sanitizers can cause significant cardiac injury, including death.The FDA said that one consumer bought a plastic bottle of hand sanitizer thinking it was water.“Drinking only a small amount of hand sanitizer is potentially lethal to a young child, who may be attracted by a pleasant smell or brightly colored bottle of hand sanitizer,” the FDA said.“I am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages. These products could confuse consumers into accidentally ingesting a potentially deadly product. It’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning,” said FDA Commissioner Stephen M. Hahn, M.D. “Manufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers.“The FDA continues to monitor these products and we’ll take appropriate actions as needed to protect the health of Americans.” 1475

The FBI's top liaison on Capitol Hill is out.Greg Brower, an FBI assistant director and head of the Office of Congressional Affairs, stepped down last Friday after a year on the job. In the role, Brower was on the receiving end of a pack of congressional probes into the law enforcement agency's conduct.The decision, a "tough" one he made of his own accord, Brower said, follows other high-level departures from the bureau as FBI Director Christopher Wray assembles his own team of close advisers."It was tough but I had an offer I couldn't refuse from a great law firm," Brower said in an interview Thursday. "It was very gratifying to be a part of that team. I could not be more proud of how people work and how committed they are to the mission."Brower was appointed to the position by then-FBI director James Comey in March of 2017 after serving as the bureau's deputy general counsel. He will join the lobbying and law firm Brownstein Hyatt Farber Schreck as a shareholder in the litigation department.The work in the legislative affairs office has heated up during Brower's tenure, as the fallout from Comey's firing by President Donald Trump has fanned a growing mistrust of the FBI among some lawmakers and spurred a round of congressional investigations.Not long before Brower's departure, the chairman of the House Judiciary Committee slapped the Justice Department with a subpoena for documents related to a trio of recent controversial decisions made by the FBI, including the move in 2016 to not charge Hillary Clinton after the probe of her email server and the internal recommendation by an FBI office to fire former FBI Deputy Director Andrew McCabe.In response, Wray said last week that the pace of document production for congressional inquiries at the bureau was "too slow" and doubled the number of FBI staff responsible for reviewing the records.On Thursday, Brower said he had worked with the FBI's Office of the General Counsel, which reviews the internal documents for release, before his departure to get a "a better plan in place" to respond to "an unprecedented wave of oversight requests.""That's all really on track," Brower said, adding that his decision to leave had nothing to do with the probes. "As the director mentioned, it's probably taking longer than it should, but the volume is just so unprecedented that we finally had to put more people on it."Brower's year atop the office saw big wins for the bureau on Capitol Hill, including a six-year extension of the controversial foreign surveillance program known as FISA Section 702 in January and the recent passage of the CLOUD Act, which makes it easier for the US to collect data stored overseas."I felt like the biggest things I set off to do in '17 were done and I felt less bad about leaving," he said.Brower is the fifth top adviser to the director to leave his position since Trump tapped Wray to replace Comey in June. 2943
The Environmental Protection Agency blocked reporters from several news outlets from a national summit on Tuesday where Scott Pruitt, the agency's chief, was speaking.Journalists from CNN, the Associated Press and E&E News, a publication that covers energy and environment issues, were barred by the EPA from entering the event, which was focused on harmful chemicals in water. A handful of other reporters from other news organizations, however, were allowed inside the event for Pruitt's opening remarks after having been previously invited by the agency the day before.In a statement, Jahan Wilcox, an EPA spokesman, said the agency barred reporters from attending due to space limitations inside the venue. He said the EPA was able to accommodate only 10 reporters and that it provided a livestream "for those we could not accommodate.""This was simply an issue of the room reaching capacity, which reporters were aware of prior to the event," Wilcox said.A report published by The Hill, however, said a handful of seats in the press section remained vacant by the time Pruitt began speaking. Another reporter told Politico there were dozens of empty seats in the room, and a photo obtained by CNN also showed space for cameras.Additionally, the Associated Press said in a story that one of its reporters, denied entry, was grabbed by security guards and forcibly shoved out of the building after asking to speak to an EPA public affairs person. A CNN photographer saw the female journalist being shoved out of the building by a uniformed guard, and the Associated Press journalist recounted the incident to CNN immediately after it took place.When reached by phone and asked about the Associated Press report, Wilcox declined to comment to CNN beyond his original statement, which said he was "unaware of the individual situation that has been reported."CNN was also blocked from attending the summit. A CNN photographer was screened by security guards before the event and was waiting for an escort or further information. Wilcox arrived soon after and provided security with a list of news outlets and reporters, instructing them not to let anyone not on the list into the event. The CNN photographer then asked if he could enter the event and was told by security he couldn't.Separately, a CNN reporter and producer lined up with members of the public and presented their IDs and credentials, identifying themselves as reporters. The individual manning the door said he needed to ask the press office if they could be permitted to enter. A few minutes later, he returned and said the CNN journalists were not allowed in.In a statement, a CNN spokesperson said, "Today, CNN was turned away from covering the PFAS National Leadership Summit at the EPA after multiple attempts to attend. While several news organizations were permitted, the EPA selectively excluded CNN and other media outlets. We understand the importance of an open and free press and we hope the EPA does, too."Sally Buzbee, executive editor of The Associated Press, said in a separate statement, "The Environmental Protection Agency's selective barring of news organizations, including the AP, from covering today's meeting is alarming and a direct threat to the public's right to know about what is happening inside their government."Buzbee added, "It is particularly distressing that any journalist trying to cover an event in the public interest would be forcibly removed."Following the media firestorm, the EPA reversed course and opened the second portion of the summit, which Pruitt was not scheduled to speak at, to the press. 3621
The Federal Aviation Administration has issued a safety alert about flying with dry ice onboard, in anticipation of the huge nationwide distribution project anticipated to start in the next few days once the Pfizer COVID-19 vaccine is approved for use.The Pfizer and Moderna vaccines both need to be kept at extremely cold temperatures, requiring the use of dry ice during transit.Dry ice is frozen carbon dioxide that is pressed into blocks or pellets. It doesn’t melt into a liquid, it moves directly from a solid to a gas and that process can happen quickly at high altitudes.That can cause problems onboard a plane, such as causing the plane to weigh less at times during the flight and change its center of gravity.“CO2 sensors installed or carried in the aircraft or worn by the pilots and other crewmembers will assist the operator and crew in recognizing hazardous concentrations of CO2 and implementing effective risk controls,” the FAA’s safety alert recommends.In addition, they encourage maximum ventilation onboard while on the ground and in the air, asking crewmembers to check air conditioning units and auxiliary power units before flight.Exposure to elevated levels of CO2 can cause drowsiness or dizziness, and higher levels can impact breathing eventually leading to hypoxia and death.The FAA also recommends that “pilot training on specific conditions and procedures can improve pilot decision-making in the event of a CO2 detector alert or other system abnormalities.”Friday morning, Health and Human Services Director Alex Azar said Americans could begin getting the COVID-19 vaccine next week once the FDA and CDC give it emergency use approval. 1676
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