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FDA approves emergency use of monoclonal antibody for treatment of COVID-19
U.S. health officials have allowed emergency use of the first monoclonal antibody drug to help the immune system fight COVID-19, an experimental approach against the virus that has killed more than 238,000 Americans.
The Food and Drug Administration on Monday cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 symptoms who do not require hospitalization. It's a one-time treatment given through an IV.
The therapy is still undergoing additional testing to establish its safety and effectiveness. It is similar to a treatment President Trump received after contracting the virus last month.
Lilly's studies of the antibody drug are continuing. Early results suggest it may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19. A study of it in hospitalized patients was stopped when independent monitors saw the drug did not seem to be helping in that situation.
The government previously reached an agreement to buy and supply much of the early production of Lilly's drug.
Only one drug — Gilead Sciences' remdesivir — has full FDA approval for treating COVID-19. Government treatment guidelines also back using dexamethasone and other steroids for certain severely ill, hospitalized patients.
One other treatment has an emergency use designation now: Convalescent plasma, or the blood of COVID-19 survivors. No large studies have shown it to be more effective than usual care alone, however.
The new drug is part of an emerging family of biologic therapies that offer a promising new approach to preventing serious disease and death from COVID-19. Experts say the infused drugs could serve as a therapeutic bridge to help manage the virus until vaccines are widely available.
The drugs are laboratory-made versions of antibodies, blood proteins which the body creates to help target and eliminate foreign infections. The new therapies are concentrated versions of the antibodies that proved most effective against the virus in patient studies.
Regeneron Pharmaceuticals Inc. also has asked for emergency authorization for an antibody drug it is testing — the drug Mr. Trump received.
FDA regulators authorized the Lilly drug using their emergency powers to hasten the availability of experimental drugs and other medical products during public health crises.
In normal times, the FDA requires "substantial evidence" to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment's potential benefits outweigh its risks.
The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Lilly will have to submit additional research to fully define the drug's safety and benefit for patients.
The government has signed an agreement with Lilly to spend $375 million to buy 300,000 vials of the drug. How many doses that would provide is unclear.
https://www.cbsnews.com/news/fda-approves-emergency-monoclonal-antibody-for-treatment-of-covid-19/
Amazon’s Prime Video said on Tuesday it had acquired the rights for broadcasting New Zealand Cricket matches in India, marking the streaming service’s first foray into live sports in its fastest-growing market.
As part of the deal between Amazon and the New Zealand Cricket Board, Prime Video will exclusively stream all international cricket matches played in New Zealand for both men’s and women’s cricket, across all formats of the game beginning late 2021 and through to the 2025-2026 season, the company said in a statement.
“We are excited to add India’s most loved game — cricket — to our content selection for our Prime Video customers, and we are thrilled to work with New Zealand Cricket on this endeavour … and the cricketing rivalry between the two countries has been fantastic,” said Gaurav Gandhi, India head of Amazon Prime
Video.
The New Zealand cricket board earlier announced a six-year domestic streaming deal with Spark Sport, which starts with matches against West Indies at home, starting later this month.
Amazon has previously shown interest in the rights to India’s Premier League cricket, while Facebook had narrowly lost out to Walt Disney-owned Star’s combined bid for TV and digital rights for the popular 20-over tournament.
Globally, Amazon has bet big on sports as a way to bolster its movie and originals catalogue. It live streams various sports, including Thursday Night Football, the Premier League, ATP Tour Events, and the U.S. Open tennis.
In India, Amazon competes with global rivals Disney and Netflix.
Its loyalty program Prime, which gives customers faster shipping and video and music streaming, costs 999 rupees ($13.51) for an annual subscription.
https://www.cnbc.com/2020/11/10/amazons-prime-video-wins-rights-to-air-nz-cricket-matches-in-india.html
Florida cities mop up after deluge from Tropical Storm Eta
FORT LAUDERDALE, Fla. – Cities in South Florida mopped up after Tropical Storm Eta flooded some urban areas with a deluge that swamped entire neighborhoods and filled some homes with rising water that did not drain for hours.
It was the 28th named storm in a busy hurricane season, and the first to make landfall in Florida. This year tied the record with 2005, when Hurricanes Katrina, Rita and Wilma struck the Gulf Coast. But that was before Theta formed late Monday night over the northeast Atlantic, becoming the basin's 29th named storm to eclipse the 2005 record.
After striking Nicaragua as a Category 4 hurricane and killing nearly 70 people from Mexico to Panama, Eta swept over South Florida, then moved Monday into the Gulf of Mexico near where the Everglades meet the sea, with maximum sustained winds of 50 mph (85 kph).
Broward County, which includes Fort Lauderdale, was among the harder hit areas.
"It’s very bad. In the last 20 years, I've never seen anything like that," said Tito Carvalho, who owns a car stereo business in Fort Lauderdale and estimated the water was 3 feet (less than a meter) deep in some places. Some items in his business were damaged from the flooding, he added.
Firefighters pulled a person from a car that had driven into a canal Sunday night in Lauderhill, north of Miami. The patient was hospitalized in critical condition, authorities said.
“It was far worse than we could’ve ever imagined, and we were prepared," said Arbie Walker, a 27-year-old student whose Fort Lauderdale apartment was filled with 5 or 6 inches (13 to 15 centimeters) of water.
"It took us 20 minutes to navigate out of our neighborhood due to the heavy flooding in our area,” Walker added. Floodwaters also submerged half of his sister’s car.
As much as 16 inches (40.6 centimeters) of rain damaged one of the state’s largest COVID-19 testing sites, at Miami-Dade County’s Hard Rock Stadium, officials said. Throughout the pandemic, it has been one of the busiest places for people to get a coronavirus diagnosis. The site was expected to be closed until Wednesday or Thursday.
All of the testing sites in Miami-Dade, Broward and Palm Beach counties managed by the state government closed on Sunday and Monday due to the storm. At least seven testing sites were to remain closed Tuesday.
Eta hit land late Sunday as it blew over Lower Matecumbe, in the middle of the chain of small islands that form the Keys.
Article continues lengthy.
https://abcnews.go.com/US/wireStory/florida-cities-mop-deluge-tropical-storm-eta-74121022
Polis extends mask mandate, urges Coloradans to 'buckle down' amid state's COVID-19 surge
Hope and hard truths converged Monday afternoon when Colorado Gov. Jared Polis discussed what's next for the state amid its ongoing COVID-19 spike during a live video update.
Despite the fact that Colorado is experiencing its highest rates of infection and hospitalization due to the virus, Polis said the state is likely in the final sprint of its COVID-19 marathon after promising vaccine news was released Monday.
Drug maker Pfizer announced encouraging results in early tests of its COVID-19 vaccine trial — indicating the vaccine was more than 90% effective in preventing the virus. Pfizer will seek emergency authorization of the vaccine from the U.S. Food and Drug Administration later this month. The company plans to manufacture enough to immunize 15 to 20 million people by the end of the year, according to the company.
https://www.msn.com/en-us/news/us/polis-extends-mask-mandate-urges-coloradans-to-buckle-down-amid-states-covid-19-surge/ar-BB1aQJhv
Colorado anon remindS everyone that we have been under mask mandates since 7/14/2020 so IMO this should clearly indicate masks don’t work! And vaccine pushing continues.
Gavin Newsom's shortlist to replace Kamala Harris in the Senate starts to take shapeCalifornia Gov. Gavin Newsom will have to name a replacement for Vice President-elect Kamala Harris in the United States Senate, and his shortlist appears to be taking shape.
In the days after Joe Biden was declared president-elect by news networks, several publications tapped into their sources plugged into the California political landscape to figure out whom Newsom might appoint. There appears to be a front-runner.
Politico reported that California Secretary of State Alex Padilla, a longtime ally of Newsom's, is "a leading contender" since Newsom wants to make a "historic choice" and Padilla would be the state's first ever Latino senator.
Longtime Newsom adviser Nathan Ballard told NPR, "Diversity is a given. It's not going to be someone who looks like Gavin."
"Gavin Newsom has just a handful of close friends," Ballard told NPR. "And Alex is one of them. He's part of that inner circle."
Finally, Variety reported that according to multiple consultants in Hollywood familiar with Newsom's thinking, "Padilla has emerged as a consensus favorite in the state."
Padilla became a member of the Los Angeles City Countil at age 26 in 1999, and then joined the state Senate in 2006. He became California's secretary of state in 2015, and all three reports note thatif Newsom appoints Padilla, he would also get to appoint Padilla's replacement, giving him the ability to appoint two allies to powerful statewide posts.
There also appears to be a well-defined second tier of candidates, with Politico reporting that Reps.Barbara Lee and Karen Bassare "high on the list" as Newsom may face pressure to appoint another woman of color to succeed Harris. Bass and Lee were mentioned as strong contenders in the NPR and Variety stories as well.
From there, a whole host of names including San Francisco Mayor London Breed, Oakland Mayor Libby Schaaf, Long Beach Mayor Robert Garcia, Attorney General Xavier Becerra and Reps. Adam Schiff and Katie Porter are considered to be "in the mix."
Schiff, who chaired the House Intelligence Committee and was a central figure in Trump's presidency, appears to be unlikely to fill the seat given Newsom's reported interest in diversity. Variety also reported that "there’s talk of Schiff eyeing a run for [Dianne] Feinstein’s seat in a few years."
https://www.sfgate.com/politics/article/Gavin-Newsom-Kamala-Harris-Senate-replacement-who-15713045.php