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Eli Lilly Seeks FDA Approval On Coronavirus Treatment, Potentially Easing Rush For A Vaccine

KEY POINTS

  • Eli Lilly’s three trials over the summer yielded positive results in patients with mild- to moderate-cases of coronavirus
  • The company could have nearly 1 million doses ready for distribution by the end of 2020 with FDA approval
  • Temporary protections provided by the antibody treatment could potentially give pharmaceutical companies more time to develop stronger vaccines

Pharmaceutical company Eli Lilly & Co. asked the U.S. Food and Drug Administration Wednesday to authorize the use of a potential coronavirus treatment that’s shown promising results during clinical trials.

Eli Lilly asked the FDA to authorize the drug’s emergency use after results for their first three clinical trials all came back positive in people with mild- to moderate-cases of coronavirus. If approved, Eli Lilly said it could have 100,000 doses ready to go within a month and 1 million ready by the end of 2020.

However, it would not be used on more severe cases, since it has not proven to be as effective in treating those cases.

The drug, codenamed LY-CoV555, is in an antibody drug Eli Lilly has been developing with Canadian pharmaceutical company AbCellera Biologics Inc. AbCellera started by taking blood samples from one of the first coronavirus patients in the U.S. to recover when it began working with Eli Lilly. The two then started developing an antibody drug treatment based on the antibodies found in the patient’s blood sample.

Trials began in June, when hospitalized patients being treated for coronavirus were dosed randomly with either the drug or a placebo to measure the drugs effectiveness. After results showed the drug helps treat the virus, phase 2 trials were conducted among vulnerable populations who were randomly administered a placebo or one of two potential drugs, including alternate antibody treatment LY-CoV016.

The most recent trials were conducted in nursing homes and, as before, showed the drug helped treat the symptoms of coronavirus and could temporarily protect against it. The latter half of the results would be important because it could ease the pressure on other pharmaceutical companies to develop a full vaccine.

One company which would benefit from this, in that regard, is AstraZeneca Plc. U.S. trials for AstraZeneca’s potential vaccine have been on hold since September after one patient was diagnosed with unexpected neurological symptoms after being inoculated. Trials have continued overseas.

That said, AstraZeneca may still rush to get a vaccine out as its pledge not to profit from it runs through July 2021. Under its current contractual agreement, Astrazeneca could declare the pandemic over by then and begin profiting off its distribution. The period could be extended if AstraZeneca acts “in good faith” if the pandemic is not considered over.

The company said it expects to receive an update about possibly resuming its U.S. trials in the next two weeks.

Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company's experimental Covid-19 vaccine Nita Patel, director of antibody discovery and vaccine development at Novavax, lifts a vial containing the company’s experimental Covid-19 vaccine Photo: AFP / ANDREW CABALLERO-REYNOLDS

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Mayor Lori Lightfoot Easing COVID Restrictions On Bars, Restaurants, Fitness Centers, Personal Services

CHICAGO (CBS) — Chicago restaurants will soon be able to serve more people indoors, and bars that don’t serve food will soon be able to resume service inside under loosened COVID-19 restrictions announced by Mayor Lori Lightfoot on Monday.

The city also is easing restrictions for health and fitness clubs and for personal services.

“Being able to open further today is just one small step that we’re taking based on what we’re seeing in the data,” Lightfoot said. “It also means that difficult decisions and sacrifices that we’ve all had to make are moving us slowly but surely forward.”

The mayor said the move comes after the city has seen improving COVID-19 data over the past month, including lower rates of infection and fewer emergency room visits.

“It was because of the citywide cooperation and collaboration that Chicago never saw a huge surge in cases once we started to gently reopen,” Lightfoot said. “All the modeling predicted that we would see a surge. The question was only how large, and luckily because of all the hard work and sacrifice of so many, including individual residents, that fate didn’t come to us.”

The new rules will go into effect on Thursday when indoor capacity at restaurants will be increased from 25% to 40%, with a maximum of 50 people per room and six people per table.

Bars that serve alcohol but not food will be limited to 25% capacity indoors or a maximum of 50 people, whichever is lower. Customers can stay no longer than two hours and cannot order at the bar, only at tables. Bars that don’t serve food themselves also must partner with a restaurant or other establishment to make food available to customers at all times through delivery services.

Restaurants and bars that serve alcohol also will be able to stay open until 1:30 a.m. but must stop serving booze at 1 a.m. Liquor stores must still halt alcohol sales at 9 p.m.

Customers at bars and restaurants must continue to wear masks while seated, unless eating or drinking. That means they must wear masks whenever interacting when servers or staff, including when placing orders, when their food or drinks are delivered, and when they’re paying their checks.

“I know that t his requirement is a pain in the butt. Let’s just be blunt about it, but it’s absolutely necessary to protect you and protect other diners, and most importantly protect the workers who are coming to your table,” Lightfoot said.

In addition to loosening restrictions for bars and restaurants, capacity for health and fitness centers, personal services, and non-essential retail businesses also will increase from 25% to 40%. Maximum group sizes