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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

We are already in love and we haven’t even met her yet. Newest member of the Carrasco family, coming soon. ?? // @hanaasano 139

Megan and Fadil Lee's love story started when the two were freshmen in college, and it may have ended there had Fadil not sent Megan a Facebook message 25 years later. “I was like, OK, is he single or married?” Megan recalls. After dating for a year and a half, the two married, and Fadil wanted to be a first-time father. Megan was on board, despite being 45 years old and already having two adult kids. “Let's face it; we're all living longer, you know,” Megan says. “And I don't think that age should be an inhibitor for you if you're in good health and you're in good shape. I think that those options should be available to you.”Dr. Paul Magarelli, who specializes in fertility for older women, agrees. “Now that we're living to 80, 90 and 100, the idea of a baby at 50 really is not that crazy,” he says. Dr. Magarelli is helping the couple conceive through IVF. “The uterus doesn't age; it’s a muscle. So, they've done successful IVF and women with donor egg up to age 74 and still got healthy babies,” Dr. Magarelli says. Megan is planning to use her own eggs, but the reality is most older women use frozen or donor eggs. “Once you reach the age of 44 and above the number of eggs that are available to make a baby are preciously few, so most families at some point will use donor eggs,” Dr. Magarelli says. There are significant risks for both mother and baby, including gestational diabetes, pregnancy-induced hypertension, as well as pregnancy loss. Babies also have a higher risk of chromosome abnormalities, such as Down syndrome. Megan and Fadil say they are aware of the risks and are being proactive. “We are going to do genetic testing on the embryos because of our age,” Megan says. “So, we want to make sure that all the chromosomes are supposed to be there are there in full and complete.” These come along with a hefty price tag. Standard IVF treatments can cost anywhere from ,000 to ,000. Paying out of pocket for the procedure, the couple hopes everything goes right on their first try.“We both have a very strong faith, and so if stuff doesn't work out, then we're going to look at that as a sign from God that we're just not supposed to be parents at this stage in our life,” she says. 2232

DENVER, Colo. -- Megan Fischer’s life story is one of strength and triumph. Her black belt in taekwondo is proof of her ability to persevere when mind and body are pushed to their limits. It’s a challenge she chooses to take part in. However, there was a time about 15 years ago when she had to overcome a challenge that wasn't planned. “In June of 2001, I was diagnosed with a brain tumor. It was explained to me as being roughly the size of an average-sized human fist. So relatively large in the head of a 6-year-old,” Megan Fischer said. Fischer is a childhood cancer survivor. “I remember just kind of a lot of times feeling like ‘why I am I here, why am I in this situation where I’m being hurt.'” After a surgery to remove the tumor, Fischer underwent chemotherapy for 11 months. It made her very sick. But it worked, and a couple years later, Fischer was cancer free. “Now I just kind of try and advocate for other kids with cancer, and kind of help them through.” Fischer is hoping to raise awareness of the shortage of the chemo drug Vincristine. It was part of her treatment many years ago. “I don’t know if it was the reason why I was able to have so much success in my tumor disappearing, but I definitely know that the side effects of Vincristine are pretty terrible. So I don’t think that my doctors would have put me on it if they didn’t think it was going to play a role in my chemotherapy treatments,” Fischer said. Dr. Lia Gore is the Chief of Pediatric Oncology, Hematology and Bone Marrow Transplant at Children’s Hospital Colorado. She says Vincristine is the backbone of many chemotherapy regimens used. “It is actually a critical element of therapy for leukemia, for some childhood brain tumors, for several other kinds of cancers,” Dr. Gore said. She says there are two primary companies that produce Vincristine, and one recently decided to stop supplying the drug. Dr. Gore says hospitals were given very little warning. “Teva [Pharmaceutical Industries Ltd.] which was a very large supplier – large volume supplier – just decided to stop making this drug. They cited a ‘business decision.’” Dr. Gore says a drug as common and basic as Vincristine isn’t as profitable. The other company, Pfizer, has stated it'’s planning to 2265

As banks make it more difficult for hackers to get into their systems, criminals are now trying to get into retirement accounts. There are a couple of reasons why hackers would target a 401(k) and other types of retirement accounts. First, there are usually significant amounts of money in these accounts. Second, there are usually fewer safeguards when it comes to access.Consumer groups are finding that getting your retirement account breached may hurt you more in the long run. “There's no guarantee that the financial institution that holds your retirement account will return the money that's been stolen from you,” says Adam Garber, a consumer watchdog with 678