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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
Prosecutors have charged a West Seneca, New York, man with criminally negligent homicide after a dispute over wearing a face covering left an 80-year-old man dead.Donald Lewinski, 65 of West Seneca, was taken into custody Monday following an incident September 26 at Pamp's Red Zone Bar and Grill.According to Erie County District Attorney John Flynn, Lewinski got into a verbal confrontation with Rocco Sapienza - another regular at the bar - after Sapienza noticed Lewinski was not wearing a mask while bringing buckets of beer to a band playing outside.At one point, Flynn said Sapienza got up and confronted Lewinski. That's when Lewinski stood up and pushed Sapienza "hard" with both hands, the D.A. said. Sapienza fell back and hit his head on the ground. Sapienza was taken to Erie County Medical Center in nearby Buffalo, where he was unresponsive for four days. He died on September 30.The cause of death is blunt force trauma to the head, authorities said.The owner of Pamp's Red Zone released this statement:"We are all deeply saddened by the loss of Rocco. He was a part of our Red Zone family and loved by all. Our deepest sympathies go out to Rocco’s family."Lewinski is set to appear in court on Tuesday.A celebration of life for Sapienza will take place Tuesday at 11 a.m. at the Southtown Christian Center. This article was written by WKBW. 1380

The U.S.-Canada border will remain closed to non-essential travel until at least Sept. 21, Canadian Emergency Minister Bill Blair said in a tweet on Friday.The border has been closed since the pandemic began, and the closure is re-evaluated every 30 days. We are extending the reciprocal restrictions at the Canada-US border for another 30 days, till Sept. 21, 2020. We will continue to do what’s necessary to keep our communities safe.— Bill Blair (@BillBlair) August 14, 2020 The ban on non-essential travel, which has been in place since March 20, was set to expire on Aug. 21.Travel restrictions do not apply to air, freight rail, or sea travel between both countries. Commercial crossings for trade and commerce will continue as usual.Family members of Canadian citizens or permanent residents can cross the border into Canada but must stay in the country for at least 15 days. This story was first reported by WXYZ. 951
A Tennessee Highway Patrol trooper was terminated after being caught on video pulling a mask off of a protester's face.Trooper Harvey Briggs was terminated Friday for "unprofessional conduct."A video surfaced of him interacting with protester, Andrew Golden, on the State Capitol grounds. Golden was recording a traffic stop of a woman near the Capitol, during which the protester claims Briggs ripped the protester's face mask off and threw it on the ground.The Tennessee Highway Patrol released the following statement:Tennessee Department of Safety and Homeland Security Commissioner Jeff Long and Tennessee Highway Patrol Colonel Dereck Stewart today announced that a trooper in the Capitol Protection Unit has been terminated following an internal investigation into department policy violations.Trooper Harvey Briggs, a 22-year veteran of the department was served a termination notice on Friday, August 14, 2020 for unprofessional conduct. The department placed Trooper Briggs on discretionary leave with pay on August 12, after the department opened an investigation into reported policy violations on August 11.It is the Department of Safety and Homeland Security’s policy to warn, suspend, demote or dismiss any employee whenever just or legal cause exists. Employees shall not commit any act that would reflect discredit upon themselves or the department while on or off duty.The video of the full interaction can be seen below. This article was written by Rebekah Hammonds for WTVF. 1533
DENVER -- The community is rallying around a downtown shoeshiner whose business hasn’t been the same since the pandemic began.When the pandemic hit back in March, Downtown Denver started to look like a ghost town, but one man was still showing up for work every day."A shoeshiner is based on four categories: wisdom, knowledge, art and pride," Claude Thompson said. "I want my members to know I will always be there for them rain, snow, shine, it doesn’t matter."Thompson has been calling the 16th Street Mall his office for over two decades. Shining the shoes of tourists, locals, business people, and even mayors."If you are in the business world, your shoes and boots should represent your job; you go to work with a dirty shoe on, you are not going to close the deal," Thompson said.The fast-talking comedian is somewhat of a local celebrity in the area."I keep my shoes so waterproofed I believe they can walk on water," Thompson joked.He charges for shoes for boots and for a lifetime membership."He gives ya hell on your shoes," lifetime member Jason Kuzov said. "He’s funny and brightens up your day."Claude’s smile began to fade as people started to work from home. Some days he only gets one or two shines.REV Energy Services and several of Thompson's customers in the oil and gas industry started a GoFundMe to help."It will help Claude so he can keep paying his rent and buying food; we don’t know when the customers are going to come back for him," Kuzov said.You can help Claude by stopping by 16th and Welton for a shoeshine."I’m not in it for the money, I am in it to help save his sole," Thompson said. This story originally reported by Jessica Porter on TheDenverChannel.com. 1727
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