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The Dow Jones Industrial Average closed at a record high Monday, erasing the last of its pandemic losses, after a second drug company announced encouraging progress on developing a coronavirus vaccine. The Dow Jones closed at 29,950, topping the previous record set back in February. The Dow Jones has completed a long comeback after losing nearly 35% of its value over the course of six weeks during the onset of the coronavirus pandemic. While the Dow rallied at the end of spring and start of summer, the markets were sluggish in their recovery until the start of November. The S&P 500 added to the record high it reached last Friday. The Dow rose 1.6% and the S&P 500 added 1.2% after Moderna said its COVID-19 vaccine appears to be 94.5% effective, according to preliminary data. It comes just a week after Pfizer and BioNTech gave similarly encouraging numbers about their own vaccine candidate. Stocks of companies that would benefit the most from the economy climbing out of its recession led the way higher. 1032

The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has endorsed Pfizer’s coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. The group, in a 17-4 vote with one abstention, concluded that the shot appears safe and effective against the coronavirus in people 16 and older.The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. A final FDA decision is expected within days. The vaccine had already been authorization by officials in Canada and the UK.An emergency use authorization allows practitioners to administer a vaccine despite it not gaining full FDA approval. The EUA means that the vaccine is allowed to be used in non-clinical settings, which would allow Americans not in a trial or hospital setting to get the vaccine.Millions of shots would then ship to begin vaccinating health care workers and nursing home residents, but the Centers for Disease Control and Prevention will need to formally recommend the vaccine before health care officials can begin distributing the shots.Once it is authorized, it is expected that several million doses of the vaccine will immediately begin being distributed throughout the US to high-risk individuals. The first group of those expected to be inoculated includes health care workers and those who live or work in assisted living facilities.“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”Pfizer says that the vaccine is showing a 95% efficacy against coronavirus infection. It is one of two vaccines that could be approved by the FDA in the next few weeks. Moderna also has a vaccine candidate that is showing the efficacy of 95%.“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”One concern over the Pfizer vaccine is possible side effects on those prone to allergic reactions. The UK’s National Health Service is advising those prone to allergic reactions to not take the Pfizer vaccine as it investigates two health care workers having apparent reactions after receiving the vaccine.Once given authorization, officials will be forced to confront two challenges: Public confidence in the vaccine and distribution. Both the Moderna and Pfizer vaccines are required to be refrigerated until use, complicating distribution methods.Also, polls are showing that a significant number of Americans are hesitant to take the vaccine. Public health experts say getting the vast majority of Americans immunized is important in order to reach herd immunity against the virus and to allow for normalcy to return to the US.In addition to a number of public health experts saying they’ll get the vaccine as a way to instill trust, former Presidents Bill Clinton, George W. Bush, and Barack Obama said they would publicly take the vaccine in order to instill faith in the shot.Widespread access to the general public is not expected until the spring. 4342

The family of Jacob Blake is hosting a gathering in Kenosha, Wisconsin on Tuesday ahead of President Donald Trump's visit to the city.The event, which will be held near the site where Blake was shot seven times in the back by a Kenosha police officer, will include a press conference with local officials and family representatives. The event will also include a community clean-up, a food drive, a healing circle, and a voter registration booth.Several days after police officers shot Blake during an Aug. 23 altercation, protests in Kenosha grew violent. The city estimates that million in property damages have been caused by looting and burning amid the unrest.Last Tuesday, 17-year-old Kyle Rittenhouse shot three protesters, two of them fatally, after he drove 20 miles to protect local businesses. Rittenhouse has been arrested in connection with the homicides; his lawyer says that Rittenhouse was shooting in self-defense.In recent days, protests in Kenosha have been peaceful and without incident.The event held by Blake's family comes hours before a visit to the city by President Donald Trump. Several Democratic politicians, including Kenosha's mayor and Wisconsin's governor, have asked Trump to reconsider, saying his presence could stoke more violence in the city.Blake was shot during an altercation with police on Aug. 23. Police say they were responding to a call about a man at a party who "shouldn't have been there."Police attempted to take Blake into custody but say he was non-compliant. Officers say they tried to use stun guns on Blake but could still not take him into custody.Blake had previously told officers he had a knife in his vehicle. At one point during the altercation, as Blake approached his car, Officer Rusten Sheskey shot Blake in the back at least seven times. A knife was later found on the floorboard of the car.Blake is still hospitalized and is paralyzed from the waist down. Sheskey has been placed on administrative leave but has not been charged with a crime. 2020

The Food and Drug Administration says it is re-examining the safety of a medication that was approved despite concerns that not enough was known about the drug's risks.In response to questioning at a budget hearing last week, FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Nuplazid, which is the only drug approved to treat hallucinations and delusions associated with Parkinson's disease psychosis.The medication has been cited as a so-called "suspect" medication in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, as highlighted in a recent CNN report.The FDA told CNN this week that the agency had already begun conducting a new evaluation of the medication when Gottlieb was questioned about it at the hearing. The agency said the review had started several weeks ago."What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA.DeLauro pressed Gottlieb for answers on his agency's response to the safety concerns surrounding Nuplazid."How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?"Tracked by the FDA, the adverse event reports cited by DeLauro do not mean that a suspected medication has been ruled the cause of harm and are typically not the result of official investigations. But the FDA uses the information to monitor potential issues with a drug and can take action as needed: updating a medication's label, for instance, or restricting its use. In rare cases, the agency can even pull a drug off the market.When asked by CNN about what prompted the FDA's new evaluation of Nuplazid, the agency said the decision was based on a number of factors but wouldn't say what those factors were. Instead, it would only comment generally, saying that it identifies "potential signals of serious risk/new safety information" in part by using adverse event data and that the agency is not suggesting physicians stop prescribing the drug or take patients off of it while a safety evaluation is taking place.The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.But physicians, researchers and other medical experts told CNN that the high number of reports deserved a closer look to determine whether they were related to the drug. They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective.Nuplazid's review was expedited by the FDA because it had been designated a "breakthrough therapy," meaning it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market.Dr. Paul Andreason, the physician who led the FDA's medical review of Nuplazid, warned that patients taking the drug during the company's clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. But the FDA ruled that the potential benefits outweighed the risks, agreeing with an advisory committee that cited a lack of safe alternatives and the pleas from family members who claimed the drug was already helping or could help their loved ones.At that advisory committee meeting two years ago, one woman said that her grandmother had been part of the clinical trials for the drug and that Nuplazid had been life-changing."We didn't know what to expect or even if she was on the drug" or a placebo, said Zoey Wade. "We soon realized that she must be taking the drug, because she really returned to herself. Her hallucinations reduced, and she better understood what was real and what was imaginary."Shortly after Nuplazid's release, however, patients' family members, doctors and other health care professionals started reporting "adverse events" possibly linked to the medication -- including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue.During the first 10 months Nuplazid was on the market, 244 deaths were reported to the FDA in which Nuplazid was a "suspect" medication, according to an analysis conducted by the Institute for Safe Medication Practices. FDA data now show that the number of reported deaths has risen to more than 700. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.After CNN published its investigation on Nuplazid, reporters were contacted by family members who said the drug helped tame hallucinations with few apparent side effects and others who said they believe Nuplazid contributed to their family member's decline or death. Some said they had not yet reported these experiences to the drugmaker or the FDA.While the FDA has long been criticized for being too slow to approve drugs, DeLauro seized on its push to streamline the process, lambasting the agency for putting industry interests and efficiency above public health and safety.DeLauro described the number of adverse events and deaths as "staggering" and "unprecedented." She also expressed concern that the drugmaker, Acadia Pharmaceuticals, is attempting to get the drug approved for a larger population: patients who suffer from dementia-related psychosis."I don't know why it should stay on the market, especially when the FDA has not determined it to be safe and while the number of adverse events continues to soar," she told Gottlieb.In response to the congresswoman's remarks, Acadia told CNN that adverse event data alone are "not a comprehensive and accurate indicator of the safety profile of any drug." In response to CNN's earlier report on the drug, Acadia said there are a number of reasons for the higher volume of death reports, including the fact that the company distributes Nuplazid through a network of specialty pharmacies that puts the company in more frequent contact with both patients and caregivers -- meaning Acadia is more likely to receive reports of death, which it is required to pass along to the FDA.Commissioner Gottlieb told the committee that the FDA is careful about the decisions it makes and that there may be a higher tolerance for risk in situations where there is an unmet medical need, "so long as the patient is properly informed of what those risks are." This echoed what he told CNN's Dr. Sanjay Gupta in an interview earlier this month.The FDA previously told CNN that it was aware of Nuplazid's "complex safety profile" at the time of approval and required the drugmaker to place warnings on its labeling. The agency also said that, though it was continuing to monitor available information about Nuplazid, it had "not identified a specific safety issue" not already reflected on the medication's label.DeLauro's office told CNN that it plans to follow up with the FDA about its inquiry into Nuplazid. 7224

The driver who plowed down pedestrians and cyclists on a New York bike path is a "soldier of the caliphate," the ISIS terror group said on its weekly newspaper, without providing evidence to back up its claim.The attack Tuesday killed eight people and left more than a dozen others injured."One of the Islamic State soldiers in America attacked on Tuesday a number of crusaders on a street in New York City," the al-Naba newspaper reported Thursday. 457