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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

Once a week, Karelia Lanuza comes by Viola Zilio's apartment to help her with whatever she might need, whether it’s finishing a puzzle, helping with chores or reminding her to take her medications. The two will often run errands or go for walks. Often times, they’ll even stop at Zilio’s favorite café to get the traditional Cuban coffee. Lanuza isn’t a traditional caregiver. She more of a companion, according to Zilio. The pair met when Lanuza signed up to work for Papa, a new app and phone-based service for seniors. "Papa connects college students to older adults for companionship, assistance, and transportation,” says CEO and founder Andrew Parker. “It’s kind of like a grandkid on-demand." Parker thought pairing college students with seniors could fill a void he saw. “My grandfather, who we call papa, needed help but wasn't really ready for traditional healthcare services, and I thought it was weird there was nothing available before that,” Parker says. “So, I thought it would be interesting to connect him to college student, and he loved it.” Lanuza is a sophomore pre-med student, and she needed a job that fit with her busy class schedule. She passed the company's background and personality checks and got the gig. “I came over. I met Viola and we clicked instantly,” Lanuza says. “And from there, I’ve been coming every Tuesday to see her, and we hang out. It’s just like hanging out with a friend.” Zilio says Lanuza gives her someone to talk to. "Seeing her once a week is kind of like being like another grandmother to me,” Lanuza says.Currently in the Miami area, Papa costs around an hour. The service is only operating across Florida right now, but the company says they have plans to expand to several more cities nationwide soon. 1777

MINNEAPOLIS, Minn. – The former Minneapolis police officer seen kneeling on George Floyd’s neck before his death has now been charged with the man's murder. Hennepin County Attorney Mike Freeman announced Friday afternoon that ex-officer Derek Chauvin has been taken into custody and charged with 3rd degree murder, as well as manslaughter.Watch Freeman announce the charges against Chauvin in the press conference below:Chauvin is one of four officers who have been fired from the Minneapolis Police Department for their alleged role in Floyd’s death. Freeman said he expects charges to be filed against the other officers as well, but his team felt it was "appropriate to focus on the most dangerous perpetrator." Chauvin’s arrest comes less than a day after Freeman and other officials asked the public to give them time to make a charging decision in the case. During the Thursday press conference, Freeman actually told reporters, “There is other evidence that doesn’t support a criminal charge.” Now, Freeman says his team has enough evidence to charge.“We have now been able to put together the evidence that we need. Even as late as yesterday afternoon, we didn’t have all that we needed. We have now found it and have felt a responsibility to charge this as soon as possible," Freeman said Friday.Below is the criminal complaint filed against Chauvin: 1376

Ali Schroer was on board when her doctor told her she could save hundreds of dollars a month on her allergy medication by ordering it online. “I was a new professional and just trying to save some money, because it was so expensive,” Schroer says. She ordered the prescription on a website that claimed to be an online Canadian pharmacy. “It looked exactly like what I had been taking for years and years, and so, I really didn't think anything of it,” she says. But in a few weeks, she started to feel strange. “I had stomach pains and headaches and kind of achiness,” she recalls. “I would go almost into shock, like I would really get clammy and hot and get like these fever spikes.”When she told a family member about the medication she got online, they did some research and found the site had a reputation for selling counterfeit drugs. Schroer says she threw the medication away, and in within weeks, she felt completely better. Her story is a cautionary tale of the dangers of purchasing medications online. The FDA recently issued a warning letter about the Canadian drug distributor CanaRx, saying it supplied "unapproved" and "misbranded" drugs to consumers in the United States. “If you order medicines online and think they're getting them from Canada, they're probably not coming from Canada,” says Dr. Carmen Catizone, executive director of the National Association of Boards of Pharmacy. “If you walk into a pharmacy in Canada, then those are medications that are safe enough that are approved by Canada.” An attorney for the company says CanaRx only facilitates the sale of drugs by American pharmaceutical companies licensed by the FDA in original packaging. However, Dr. Catizone says because the U.S. can't regulate drugs from other countries, it's hard to know exactly where drugs you buy online come from. “If something sounds too good to be true, it's probably too good to be true for something that's licensed for a site, where you can get information from a state agency or federal government about,” Dr. Catizone explains. As for Schroer, she has decided to stop online shopping for her prescriptions.“You just don't know enough about where it comes from,” Schroer says. 2210

A Florida judge has denied a request for a temporary injunction to block the Palm Beach County mask mandate.Attorneys for a group of Palm Beach County residents filed a lawsuit claiming that the county's emergency order requiring masks in public places to help prevent the spread of the coronavirus was unconstitutional.Judge John Kastrenakes issued his ruling Monday morning."The right to be 'free from governmental intrusion' does not automatically or completely shield an individual's conduct from regulation," Kastrenakes wrote in his 13-page order. "More to the point, constitutional rights and the ideals of limited government do not absolve a cititzen from the real-world consequences of their individual choices, or otherwise allow them to wholly shirk their social obligation to their fellow Americans or to society as a whole. This is particularly true when one's individual choices can result in drastic, costly and sometimes deadly consequences to others."Kastrenakes went on to say that there is no "constitutional or protected right to infect others."Commissioners voted unanimously last month to approve the mask mandate, despite objections from an impassioned group of residents who spoke against such an ordinance.County Administrator Verdenia Baker last week extended the order for an additional 30 days. It now remains in effect until at least Aug. 23.Mayor Dave Kerner said Friday that the county is in the process of mailing about 3 million masks to residents."As this community tries desperately to navigate the tumultuous seas presented by COVID-19, it is reasonable and logical that our elected officials are throwing the citizens of Palm Beach County a lifeline in an attempt to ameliorate the spread of this deadly, unbridled and widespread disease," Kastrenakes concluded. "Based on the evidence, this court will not second guess the manner in which a co-equal branch of government sought to discharge its sacred duty to protect the general public."A statement from the Florida Civil Rights Coalition, which filed the lawsuit on behalf of the plaintiffs, said Kastrenakes "unsurprisingly" denied the motion, "paving the way for continued government tyranny under the guise of disease prevention in Palm Beach County."Attorneys for the plaintiffs argued during a hearing last week that the mask mandate infringes upon their clients' constitutional rights.In their statement, attorneys claim the ruling "disregards fundamental rights like freedom of speech and the right to medical self-determination protected by the Florida Constitution."The Florida Civil Rights Coalition plans to appeal the ruling. WPTV's Peter Burke was first to report this story. 2701

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