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INDIANAPOLIS — The U.S. Food and Drug Administration on Monday granted emergency use authorization to Eli Lilly and Company's experimental COVID-19 antibody treatment bamlanivimab.According to a statement from the company, the drug is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalization. Lilly said in a statement the drug should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion."This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients — adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," David A. Ricks, Lilly's chairman and CEO, said. "The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most."The emergency use authorization is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with the drug showed reduced viral load and rates of symptoms and hospitalization, Lilly said in the statement. Infusion reactions and other allergic hypersensitivity events have been reported, Lilly said. The emergency use authorization includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.Lilly said the drug is not authorized for use in patients who are hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19 or who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity."The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said. "We're proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19. We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country." This article was written by Bob Blake for WRTV. 2906

Boeing's bestselling passenger jet is facing increased scrutiny after being involved in two deadly crashes in less than five months, a situation that threatens to tarnish the US plane maker's reputation for safety.Chinese aviation authorities on Monday told airlines in the country to ground all their Boeing 737 MAX 8 aircraft, citing the need for "strict control of safety risks." Some individual airlines are taking similar action elsewhere. And Boeing has postponed the debut of its new 777X jetliner, which was scheduled for this week, as it deals with the fallout from Sunday's disaster in Ethiopia.The flurry of negative headlines unsettled investors. Boeing shares dropped nearly 9% in premarket trading early Monday in New York.All 157 people on board a 737 MAX 8 operated by Ethiopian Airlines were killed when the plane crashed shortly after takeoff on Sunday morning. In late October, a 737 MAX 8 flown by Lion Air went down off the coast of Indonesia, killing 189 people.Both the Ethiopian Airlines and Lion Air planes were brand-new aircraft. And both crashed minutes into flight.Ethiopian Airlines said Monday that it was grounding its fleet of 737 MAX planes as an "extra safety precaution," and Cayman Airways, the main carrier of the Cayman Islands, said it would do the same until "more information is received."The circumstances of the two crashes remain under investigation, and Boeing has presented no evidence to suggest the two disasters are linked. The similarities may be a coincidence."A formal investigation will need to be conducted into this new crash. It's important not to speculate as to its causes. A final, conclusive report has yet to be issued in the case of the Lion [Air] crash," said Greg Waldron, Asia managing editor at aviation research firm FlightGlobal."That said, having two crashes of a brand new type in a short time is an unprecedented state of events," he added. "It is inevitable that this will affect perceptions about the 737 MAX family."The decision by Chinese authorities to ground 737 MAX 8 planes in the country is a serious blow."A suspension in China is very significant, as this is a major market for Boeing," Waldron said. Chinese airlines have 97 of the 737 MAX aircraft in service, more than a quarter of the total in operation worldwide, according to FlightGlobal.Boeing's bestsellerThe single-aisle Boeing 737 has been a workhorse on short- and medium-haul flights for decades. The 737 MAX is the latest version — and the company's bestselling aircraft by far. Airlines have ordered thousands of them.The two-year-old 737 MAX 8 model in particular is hugely popular (the MAX 9 only recently went on sale and Boeing has not yet delivered the MAX 10). Last year, 72% of Boeing's deliveries were 737 planes. Boeing plans to make 59 new 737s each month this year — more than four times the number of 787s, Boeing's next-best seller.Southwest Airlines has the largest fleet of 737 MAX 8 airplanes, followed by RyanAir and FlyDubai, according to 3018

INDIANAPOLIS — The U.S. Food and Drug Administration on Monday granted emergency use authorization to Eli Lilly and Company's experimental COVID-19 antibody treatment bamlanivimab.According to a statement from the company, the drug is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test who are at high risk for progressing to severe COVID-19 and/or hospitalization. Lilly said in a statement the drug should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion."This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients — adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," David A. Ricks, Lilly's chairman and CEO, said. "The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most."The emergency use authorization is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with the drug showed reduced viral load and rates of symptoms and hospitalization, Lilly said in the statement. Infusion reactions and other allergic hypersensitivity events have been reported, Lilly said. The emergency use authorization includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.Lilly said the drug is not authorized for use in patients who are hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19 or who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity."The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said. "We're proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19. We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country." This article was written by Bob Blake for WRTV. 2906

It's no secret that voting in this year's election is entirely different from what we've done in years past. With that, there are many concerns about mail-in ballots, and whether or not they favor one political party over another.Bakersfield College political science professor Allen Bolar says the rumor has always been that mail-in voting favors Democrats. He says that rumor hasn't historically been true, until now."The Republican party is gonna be sending mail-in voter ballot applications to its voters, but on the other hand, the top of its ticket is saying that you can't trust the mail-in voting," Bolar said.This year, votes received by mail will likely be more skewed favoring democrats, Bolar said. The professor explaining that mostly has to do with the rhetoric coming from the White House for months, denouncing the mail-in vote system's integrity."You have tremendous potential for fraud and abuse," President Donald Trump said about mail-voting this summer.Bolar says some Republicans, heading President Trump's words, may avoid casting their vote via mail. Meanwhile, Democrats are expected to be turning out in higher numbers. Democrats have cast about 51% of the early votes, according to a predictive analysis by the data firm TargetSmart, which uses voter data to project turnout trends. That's compared with 38% by Republicans. Bolar says republicans will mostly vote in other ways, like at the poll on election day."Many Republican voters are die-hard Republican voters. They're going to show, and do whatever they need to do," he said.Bolar says the one advantage that may come out of this for Democrats, is that when a party's base votes early, it allows the party to focus their campaign calls and mailers on a smaller set of people who haven't voted."Whereas the Republican party is going to have to keep worrying about its whole set of voters, or at least a large number of them, and its efforts are going to be a little harder to concentrate," he said. This story original reported by Austin Westfall on Turnto23.com. 2071

During his visit to Wisconsin on Thursday, Joe Biden sat down with Charles Benson, a reporter for Scripps' Milwaukee station, to discuss his campaign and the message he wants to spread. Thursday marked Biden's first stop in Wisconsin since the start of his campaign. You can watch the full video above. Benson's conversion with Biden is organized by topic below.MORE COVERAGE:Joe Biden stresses unity in visit to Kenosha, talks to Jacob Blake and his familyJacob Blake speaks by phone with Joe BidenKenosha residents react to Joe Biden visiting Kenosha: 'This community needs healing'Joe Biden discusses meeting with Jacob Blake and his family: Biden discusses meeting with Blake family Biden shares his message to law enforcement: Biden's message to law enforcement Joe Biden: 'Racism is a national health crisis': Biden: Racism is a national public health crisis This article was written by Charles Benson for WTMJ. 1052

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