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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
ARLINGTON, Va. – Within an hour of a food bank’s opening came a delivery organizers have been counting on: frozen chicken by the pallet. “Two weeks ago, we began preparations for the future,” said Charles Meng, director of the Arlington Food Assistance Center in Virginia. Meng remembers the last time they encountered a sudden spike in need – right after 9/11. “We saw a very significant increase at that time,” he said. “And so, this is just that on steroids.” The center typically serves about 80,000 pounds of food to 2,400 families a week. One-third of those they help are children under 18, but the numbers are starting to climb. “We expect to see is many more of those families come to us. That's really going to be the first bump up,” Meng said. Like many food banks across the country, the economic conditions brought on by the coronavirus are stretching their resources and those of families all over the country. “It will last them until we come back on Friday and I don’t have to worry about what they’re eating,” said one parent, Sarah Baldrick, who was in Ohio picking up food, during a distribution at a local school there. There is some cause for concern, though, when it comes to food bank donations. So far, the food assistance center says they are still getting help from corporations, companies and individuals. However, they are seeing trouble from some supermarkets. “That amounts, in our case, to about 40-percent of the food we distribute -- have all but dried up,” Meng said of the food bank’s supermarket donations. “So, we're going to have to significantly increase the purchasing of food for our families.” That means they now have to count on monetary donations to buy food for those in need, at a time when people’s pocketbooks are taking a hit. “I'm relying on the generosity of this community,” Meng said. “We all have a need to survive this time.” It is a time that’s now filled with uncertainty.For more information on the Arlington Food Assistance Center, 2004

Here's a look at all the local mall hours around San Diego to make sure your holiday shopping goes smoothly.Fashion Valley Mall (7007 Friars Rd.) 160
CYPRESS, Calif. -- It’s Friday the 13th and finals week at Cypress College in Southern California. A chilling combination for some, but for other students it’s just another day at school. They’re studying for a career that’s not for everybody – but a career that will eventually impact just about everyone. These students are prepping for their final exams in mortuary science, a degree where they can make a living while dealing with death.“This is from what I’ve learned is a gasket casket,” said Karla Ruiz, a Cypress College mortuary science student. Ruiz has a goal of advancing her career from a local morgue to national security. “I’m really into watching a bunch of CIA stuff or like crime stuff,” she said. “So, I want to find something that can open the door for that.” Cypress College is one of about 60 colleges across the country that offer this kind of end-of-life education. It may seem like a grim career choice, but the mortuary science industry is now attracting different kind of demographics. “As far as male female it’s certainly changed,” said Damon de la Cruz, Cypress College mortuary science assistant professor. “It wouldn’t be hard for us to see in a graduating class of 20 something like three males and 17 females. It’s really shifted in that direction.” It’s a direction where there’s now a growing demand for qualified workers. “There’s not enough students to meet the demand of the community,” de la Cruz said. “As result of that many of our students are placed or they get hired before they even graduate.” The Bureau of Labor Statistics reports the median annual wage for morticians, undertakers and funeral directors is more than ,000 a year. Funeral service managers can make closer to ,000. “I’ve been in this industry for a long time and I’ve had many opportunities presented to me to where I’ve grown, been able to afford a house, and be able to live comfortably in southern California,” said Harbor Lawn Mortuary funeral director Michael Roudebush. Roudebush has hired several Cypress College students through the years. He says a career in mortuary science can be financially rewarding but also emotionally draining “Empathetic and compassionate people are what we’re always looking for,” Roudebush said. “We are people too and we’ve been through what the families have been through. We all experience loss.” Back on the college campus, students like Ruiz are gaining an understanding of death that they can use for a lifetime. She says that after studying death, she now appreciates life more. “Ever since doing this I’m closer to my family,” she said. “I actually want to go home and hang out with them.”A celebration of life that comes from knowing exactly what others have lost. 2746
Ohio has been added to the Ohio Department of Health’s COVID-19 Travel Advisory map, meaning the state is recommending Ohioans avoid traveling to Ohio, and those entering Ohio after traveling from Ohio are advised to self-quarantine in Ohio for 14 days.Obviously, outside of The Matrix or a Christopher Nolan movie, this is physically impossible. To be clear, you are free to move about the state, but the ODH recommends staying home except for necessary trips.The ODH included this statement on this week's travel advisory: "This is the first week since April where Ohio’s positivity for COVID-19 has increased above 15%. The state has seen record levels of cases, deaths, and hospitalizations in the past week, and all Ohioans can help to limit the spread and impact of this virus. This includes recommendations to stay at home except for necessary trips for supplies, consistent mask-wearing when around others, and frequent hand washing. Together we can help stop the spread of COVID-19."Ohio was added to its own travel advisory map because, as ODH states, the 7-day rolling average positivity rate for COVID-19 tests in the state rose above 15% for the first time since April this week. Any state with a positivity rate above 15% is put on the map, and the ODH recommends against travel to those states with high positivity.The positivity rate is an indicator of how much COVID-19 there is in a community, ODH states, and comes from state-level aggregate data from The COVID Tracking Project. The travel advisory is updated each Wednesday, based on data from Tuesday.The 13 other states included in Wednesday’s travel advisory and their average positivity rates are:Idaho - 49.0%Iowa - 43.4%South Dakota - 41.1%Kansas - 40.0%Alabama - 33.0%Pennsylvania - 29.0%Arizona - 23.0%Mississippi - 22.0%Utah - 20.0%Missouri - 19.0%Nevada - 17.0%Montana - 15.0%Arkansas - 15.0%The advisory and self-quarantine recommendations are intended for both leisure and business travel and should be heeded by both Ohioans and out-of-state travelers, the ODH stated. It is also guidance and not a mandate.For more information on the state's travel advisory, and recommendations for self-quarantining in Ohio after traveling to Ohio from Ohio, click here. This article was written by Ian Cross for WEWS. 2311
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