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Merck asks U.S. FDA to authorize promising anti-COVID pill

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Merck asks U.S. FDA to authorize promising anti-COVID pill

WASHINGTON — Drugmaker Merck asked U.S. regulators Monday to authorize its pill against COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.

If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection.

An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on U.S. hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.

The FDA will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before rendering a decision.

Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.

“The value here is that it’s a pill so you don’t have to deal with the infusion centers and all the factors around that,” said Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit. “I think it’s a very powerful tool to add to the toolbox.”

The company reported earlier this month that the pill cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.

Side effects were similar between patients who got the drug and those in a testing group who received a dummy pill. But Merck has not publicly detailed the types of problems reported, which will be a key part of the FDA’s review.

Top U.S. health officials continue to push vaccinations as the best way to protect against COVID-19.

“It’s much, much better to prevent yourself from getting infected than to have to treat an infection,” Dr. Anthony Fauci said while discussing Merck’s drug last week.

Still, some 68 million eligible Americans remain unvaccinated, underscoring the need for effective drugs to control future waves of infection.

Since the beginning of the pandemic, health experts have stressed the need for a convenient pill. The goal is for something similar to Tamiflu, the 20-year-old flu medication that shortens the illness by a day or two and blunts the severity of symptoms like fever, cough and stuffy nose.

Three FDA-authorized antibody drugs have proved highly effective at reducing COVID-19 deaths, but they are expensive, hard to produce and require specialty equipment and health professionals to deliver.

Assuming FDA authorization, the U.S. government has agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment. That’s less than half the price of the antibody drugs purchased by the U.S. government — over $2,000 per infusion — but still more expensive than many antiviral pills for other conditions.

Merck’s Kartsonis said in an interview that the $700 figure does not represent the final price for the medication.

“We set that price before we had any data, so that’s just one contract,” Kartsonis said. “Obviously we’re going to be responsible about this and make this drug as accessible to as many people around the world as we can.”

Kenilworth, New Jersey-based Merck has said it is in purchase talks with governments around the world and will use a sliding price scale based on each country’s economic means. Also, the company has signed licensing deals with several Indian generic drugmakers to produce low-cost versions of the drug for lower-income countries.

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Lewis & Clark Community College partially reopens after cyberattack

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Lewis & Clark Community College partially reopens after cyberattack

GODFREY, Ill. – Lewis & Clark Community College is reopening its campus Monday to team members only.

The school shut down just weeks before finals due to a ransomware attack on November 23. The school was forced to shut down everything from its phones to the website’s home page.

Student activities and events will all return to a normal schedule starting Tuesday morning.

All classes, campus events, program events, and athletic events were canceled last week as the college’s IT department worked to resolve the matter.

Students were told they will not suffer any academic penalty for this disruption.

Due to the attack, all of the electronic systems on campus were taken offline to prevent further problems. It’s not been made clear how the attack occurred.

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Kiszla vs. O’Halloran: Did Broncos throw too much money at receivers Courtland Sutton and Tim Patrick?

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Kiszla vs. O’Halloran: Did Broncos throw too much money at receivers Courtland Sutton and Tim Patrick?

Kiz: Broncos general manager George Paton recently spent more than $95 million, including in excess of $50 million guaranteed, in new deals for receivers Courtland Sutton and Tim Patrick. During an embarrassing 22-9 loss to Kansas City, however, Sutton and Patrick produced only three receptions for a grand total of 24 yards after being targeted 11 times by quarterback Teddy Bridgewater. Did Paton throw good money down the drain?

O’Halloran: Handing out receiver contracts days apart remains an interesting development, particularly because Jerry Jeudy is making plays befitting a No. 1 target. But two games is too small of a sample size to serve as a judgment on the deals because Paton is playing the long game, trying to keep (and then gather) assets that make the Broncos attractive to a veteran quarterback next March. But the numbers also don’t fib — Sutton and Patrick should be more involved. In the last four games, Sutton has nine catches and Patrick 13.

Kiz: The Denver offense definitely isn’t explosive and often isn’t efficient. Should we place all the blame at the feet of offensive coordinator Pat Shurmur and Bridgewater? Or is it fair to wonder that outside of rookie running back Javonte Williams and 2020 first-round pick Jerry Jeudy, the Broncos’ simply don’t have enough playmakers? Patrick can help you move the sticks on third down. But is either he or Sutton a true big-play threat?

O’Halloran: Much of the criticism should be directed at the play-caller (Pat) and trigger man (Teddy), which you correctly took to task after the Chiefs’ 12th consecutive win over the Broncos. Where is the originality? Where is the smart-but-aggressive chances? Where is the downfield accuracy? The Broncos called an early shot to Patrick, but Bridgewater overthrew him. They threw a pass to Sutton down the right sideline, but he couldn’t break free of coverage. And they went deep to Sutton, but the pass wasn’t anywhere close to being accurate. In the biggest game of the year, the Broncos were particularly short-handed at quarterback.

Kiz: I understand the logic behind the new deal for Patrick. He’s a football warrior. While Sutton is a solid teammate and stand-up guy, he doesn’t strike me as either a true No. 1 receiver or a target who will make it any more likely for Russell Wilson or Aaron Rodgers to dream of playing quarterback for the Broncos in 2022. While I firmly believe Paton has shown what it takes to be the GM who returns this team to an elite level, I also think he showed too much love to Sutton.

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Security on Metro transit to increase following shooting of MetroBus driver

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Security on Metro transit to increase following shooting of MetroBus driver

ST. LOUIS – Officials from the region’s largest transit system, Bi-State Development, are beefing up security for bus drivers and riders after a MetroBus driver was shot Friday evening. The driver has remained in the hospital in critical condition since the incident.

MetroBus is adding private security patrols to select routes and working with law enforcement to boost police presence.

The Major Case Squad of Greater St. Louis is investigating the shooting that caused the bus driver to crash into a utility pole. The incident happened just after 7 p.m. Friday at the 3400 block of Lucas and Hunt Road. 

The driver, whose name has not been released, was hit in the upper body. There were several passengers on the bus at the time. They were not injured from the gunshot, which they said was a single gunshot from outside the bus.

While the driver remains in hospital, a vigil was held Sunday. More than 20 people gathered to pray for their co-worker and friend.

President and CEO of Bi-State Development Taulby Roach said the Metro Transit System will continue to invest in operator shields, cameras, and radios to increase security.

Police ask anyone with information on the shooting who wishes to remain anonymous to call 866-731-TIPS. Anyone with information could be eligible for a CrimeStoppers reward of up to $5,000.

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