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Merck asks US FDA to authorize promising anti-COVID pill

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Merck asks US FDA to authorize promising anti-COVID pill

By MATTHEW PERRONE

WASHINGTON (AP) — Drugmaker Merck asked U.S. regulators Monday to authorize its pill for treating 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 the illness. All other FDA-backed treatments against COVID-19 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.

The prospect of a COVID-19 pill comes amid other encouraging signs: New cases per day in the U.S. have dropped below 100,000 on average for the first time in over two months, and deaths are running at about 1,700 a day, down from more than 2,000 three weeks ago.

Also, the average number of vaccinations dispensed per day has climbed past 1 million, an increase of more than 50% over the past two weeks, driven by the introduction of booster shots and workplace vaccine requirements.

Still, heath authorities are bracing for another possible surge as cold weather drives more people indoors.

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.

Several other companies, including Pfizer and Roche, are studying similar drugs and are expected to report results in the coming weeks and months. AstraZeneca is also seeking FDA authorization for a long-acting antibody drug intended to provide months of protection for patients who have immune-system disorders and do not adequately respond to vaccination.

Some experts predict various COVID-19 therapies eventually will be prescribed in combination to better protect against the worst effects of the virus.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Probe of Brighton councilman stems from alleged DUI incident before a council meeting

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Probe of Brighton councilman stems from alleged DUI incident before a council meeting

An investigation launched last week by the city of Brighton into the conduct of Councilman Kris Jordinelli stemmed from an incident in August in which police say Jordinelli drove drunk to a city council meeting, and when later questioned at his home, identified himself as an elected official and told the officer “you don’t want to mess with me.”

City of Brighton

Brighton Councilman Kris Jordinelli

The Aug. 17 incident is outlined in a 12-page police report obtained by The Denver Post. Jordinelli, who was elected to the council in November 2019, was charged with misdemeanor DUI. The case is scheduled for a Feb. 7 hearing in Adams County.

The city’s investigation, for which the law firm of Wilson Williams LLP was hired as a special prosecutor, is limited to looking at whether Jordinelli’s alleged statement to police broke any ethical standards or municipal laws. The city is paying the firm $250 an hour for its work.

The decision by city council last week to appoint the firm to look into the matter was unanimous. Jordinelli was absent for the vote. Brighton officials declined to disclose the identity of the councilman under investigation at the time of the city council vote.

The police report states that Jordinelli, 64, arrived for the meeting “disheveled” in shorts and a polo shirt and “was walking with an unsteady gait.” Several officers described a strong smell of alcohol on his breath and video surveillance later obtained by police showed that Jordinelli had driven to city hall right before the meeting and parked his Buick “at an angle occupying two parking spaces.”

After being escorted downstairs by a fellow councilman from a hallway outside council chambers, Jordinelli was walked to his nearby home by two city staff members, the report said.

When police contacted him at home to ask him about his car being at city hall, they described Jordinelli as having “red watery eyes,” “slurred speech” and being “unsteady on his feet.” In the report, police said Jordinelli opened his garage door in an apparent effort to show officers that his car was at home. The garage was empty.

Jordinelli, according to the report, then asked the officers if they knew who he was. After informing the officers that he was a city councilman, he said “You don’t want to mess with me.”

Jordinelli on Monday said the case “arises out of my suffering a serious medical event prior to a meeting and one of my political opponents trying to use that event now, several months after it occurred, to try to oust me from office.”

“I am sad to see how low others have gone to try and get rid of me just because we may not agree on political issues,” he said in an email. “I look forward to being vindicated of this baseless charge in court.”

He did not identify who his political opponents are.

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Infotainment retuned for ’22 Infiniti QX80 resurgence

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Infotainment retuned for ’22 Infiniti QX80 resurgence

A refined infotainment system and center stack are standard on the 2022 Infiniti QX80 and should serve as major assists toward a more well-rounded competitiveness in the full-size luxury SUV field for the Japanese product.

Power and plushness are a given for the QX80 and have been for some years. Up-front interior tech, though, with dual screens lagging in wireless compatibility fared poorly in comparative assessments.

For 2022, a new 12.3-inch touchscreen offers navigation, lane guidance, Infiniti InTouch Services, Apple CarPlay and Android Auto links, Intelligent Cruise Control and Bose premium sound system with 17 speakers.

The upgraded QX80 is available in three trim levels – Luxe, Premium Select and Sensory – as it goes against Lexus LX, Mercedes GLS and G-Class, Cadillac Escalade, Lincoln Navigator, Range Rover, BMW X7 and Audi Q7.

Interestingly, while I was driving the QX80 last week came an announcement from Yokohama, Japan, of the promotion by Infiniti of Wendy Orthman to general manager of global integrated brand, marketing and communications, a newly created position merging the responsibilities of chief marketing and chief communications officer. She was global head of communications for the brand.

Orthman previously served positions with Nissan and, earlier, as Midwest PR manager with Chrysler. While with Chrysler, Denver was a frequent stop for her, including bringing famed Dodge designer Ralph Gilles here in 2008 to show off a redesigned Ram with storage in its box’s side panels.

The new version of the QX80 continues to draw notice for its size – it’s big, 6 ½ feet tall and square-bodied with 5,815-pound curb weight, riding on Bridgestone Dueler P275/50R22 tires.

Performance comes smoothly from a 400-horsepower, 413 lb.-ft. torque, 5.6-liter V-8 engine with 7-speed automatic transmission and four-wheel drive. A dial in the center console engages switching from Auto to 4Hi and 4Lo, with a separate button for snow mode, which lessens torque on takeoff. The shifter can be moved into manual mode and tapped for upshifts or downshifts.

The Infiniti is impressive in its maneuverability, belying its oversize. Its EPA fuel estimate continues relatively low, 13 to 19 miles per gallon. I averaged 16.4 mpg.

Inside, the front seating, with quilted inserts, is finished in saddle brown. The second-row buckets, with an abundance of legroom, will flip-fold forward for opening a path to the 3rd row, where footspace is very tight. By folding the far-back seats into the floor, cargo space grows from 16.6 cubic feet to a roomy 49.6. Twin 8-inch screens highlight a rear-seat entertainment system.

For $87,985, the Infiniti’s high-end Sensory trim level includes power moonroof, power-folding and heated outside mirrors, power rear liftgate, leather-wrapped and heated steering wheel, wireless phone charging, power reclining third-row seats and safety advancements forward emergency braking, blind-spot intervention, lane-departure prevention and around-view monitor with moving-object detection.

The Infiniti brand was introduced in the United States in 1989 as Nissan’s luxury offering to compete with Toyota and Honda premium units Lexus and Acura, respectively. The QX80 is built in Kyushu, Japan.

Contact Bud Wells at
[email protected]

The news and editorial staffs of The Denver Post had no role in this post’s preparation.

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Homicide investigation underway after man stabbed to death in Westminster home Monday

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100-year-old Longmont man assaulted along Main Street has died

Jefferson County authorities are investigating a homicide after a man was found stabbed to death early Monday inside a Westminster home.

Sheriff’s deputies responded at 4 a.m. to the 10400 block of Ammons Street to reports of a break-in, and upon arrival found the unidentified man dead, the sheriff’s office said in a news release.

A witness who lives at the house told police that “the male had forced entry into the home and was stabbed by another female resident during a physical altercation between the male and the witness,” authorities said in the release.

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