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Final U.S. hurdle for Merck’s COVID-19 pill: FDA panel review

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Final U.S. hurdle for Merck’s COVID-19 pill: FDA panel review

WASHINGTON — An experimental COVID-19 drug that could soon become the first U.S.-authorized pill to treat the coronavirus faces one final hurdle Tuesday: A panel of government experts will scrutinize data on the medication from drugmaker Merck.

The Food and Drug Administration is asking its outside experts whether the agency should authorize the pill, weighing new information that it is less effective than first reported and may cause birth defects. The panel’s recommendations aren’t binding but often guide FDA decisions.

Tuesday’s meeting comes as U.S. infections are rising again and health authorities worldwide scramble to size up the threat posed by the new omicron variant.

If authorized, Merck’s pill would be the first that U.S. patients could take at home to ease symptoms and speed recovery, a major step toward reducing hospital case loads and deaths. The drug, molnupiravir, is already authorized for emergency use in the U.K.

Given the ongoing threat of the pandemic the FDA is widely expected to approve emergency use of Merck’s pill. But new data released last week paint a less compelling picture of the drug than when the Merck first publicized its early results in October.

On Friday, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, significantly lower than the 50% reduction it first announced based on incomplete results.

FDA regulators said they were still reviewing Merck’s update and would present a new assessment of the drug’s benefits to the outside panel. Molnupiravir’s effectiveness is a key question as panel members weigh whether to recommend the drug and for whom.

One key question is whether the drug should be restricted from use in pregnant women or women of child-bearing age.

In its safety review, FDA staffers said animal studies suggested Merck’s drug could cause birth defects when given at high doses. Regulators said they are considering a complete ban on molnupiravir’s use during pregnancy and other safeguards, including recommending contraceptives for some patients taking the pills.

Merck’s drug uses a novel approach to fight COVID-19: it inserts tiny errors into the coronavirus’ genetic code to stop the virus from reproducing. That genetic effect has raised concerns that the drug could cause mutations in human fetuses or even spur more virulent strains of the virus.

Another key question is whether the drug should be offered to patients who have been vaccinated or previously had COVID-19. Merck didn’t study the drug in vaccinated people, but data from a handful of patients with prior infections suggested it had little benefit. Still, it may be impractical for doctors to screen out those patients. The Merck drug works best when given within five days of first COVID-19 symptoms, underscoring the need for speedy treatment.

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Nikola Jokic, Nuggets avoid fourth-quarter disaster, end homestand 4-2

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Nikola Jokic, Nuggets avoid fourth-quarter disaster, end homestand 4-2

The Nuggets don’t know easy. It’s just not in their nature.

Denver avoided what would’ve been an ugly double-digit, fourth-quarter collapse Sunday and hung on to beat the Pistons, 117-111. Up 16 points to start the fourth quarter, Detroit chiseled away at the lead, tying it twice in the final two minutes.

Former Nugget Trey Lyles added to the drama with eight of his 18 in the fourth quarter, but the Pistons were rebuffed by Nikola Jokic, who scored six consecutive points late to ice the game.

Jokic finished with 34 points, nine rebounds and eight assists, snapping his four-game triple-double streak. Not that it mattered to Jokic.

The Nuggets, now 24-21, will get the Pistons again Tuesday in Detroit to start their daunting six-game road trip. They ended their six-game homestand with a 4-2 record.

DeMarcus Cousins was relatively underwhelming in his Nuggets debut, finishing with just two points and six rebounds in 12 minutes. But he was part of a strong bench showing, which saw the Nuggets outscore Detroit’s reserves 41-37.

In addition, the Nuggets hung 60 points in the paint to help combat 18 points each from Detroit’s Isaiah Stewart and Cade Cunningham.

Each time the Nuggets looked like they’d create separation, they’d turn it over or fail to capitalize on an open 3-pointer. Finally, with 4:50 left in the third quarter, Jokic found Bryn Forbes lingering outside the 3-point line, and he drained the look. Two minutes later, reserve Davon Reed knocked in a 3, and shortly thereafter, so did Facu Campazzo.

As Campazzo trotted back on defense, he looked to the sky with relief. Zeke Nnaji canned a triple before the quarter was over, and the Nuggets’ second unit had engineered a 92-76 lead heading into the final quarter.

Playing some with Jokic and some with the reserves, Forbes looked more comfortable than he did in his debut.

“When you make a trade, in and of itself, that takes some time because you’re bringing in a new person, a new personality to a locker room, to a culture,” Nuggets coach Michael Malone said.

His prior experience with well-respected organizations like Milwaukee and San Antonio helped ease the transition.

Entering Sunday, Malone had a healthy fear of the rebuilding Pistons for one specific reason.

“As I told our players, when you’re a team like Detroit, they have nothing to lose,” Malone said pre-game.

He said human nature becomes a factor, and teams inevitably let their guard down against lottery-bound teams.

“… These games scare the hell out of me,” he said.

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Timberwolves’ offensive outburst continues in shootout win over Brooklyn

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Timberwolves’ offensive outburst continues in shootout win over Brooklyn

The Timberwolves’ formula for success has shifted over the past couple weeks.

A team that used its defense to stay afloat amid offensive struggles for the first half of the season is slowly reverting back to the form it showed at the end of last season — all offense, few stops.

And when you have as much offensive talent as Minnesota possesses, that can be enough on a lot of nights, as it was Sunday.

The Timberwolves outscored Brooklyn 136-125 to win at Target Center.

Minnesota has the best offensive rating in the NBA since Jan. 3. It’s won games with offense and a high-degree of shot making. Sunday was no different.

Anthony Edwards finished with 25 points on four triples. D’Angelo Russell added 23 points and 10 assists.

Minnesota shot 52 percent from the floor, 44 percent from 3-point range and went 26 for 31 from the free-throw line.

That was more than enough firepower to stave off Brooklyn — another of the League’s top offenses. The Nets themselves shot 51 percent from the floor and 40 percent from deep, led by 30 points from Kyrie Irving. The Wolves have had defensive slippage of late, but it’s been masked by their offensive aptitude.

Minnesota has scored 108-plus points in each of its last eight games. It’s gone over 119 points in six of those contests, and Sunday marked the third time it cleared 130 points in that stretch.

The offense that was so far behind the defense at the season’s outset — which Timberwolves coach Chris Finch has attributed to the shear amount of attention paid to the defense in training camp — has now caught up and passed the other end of the floor. The Wolves now more closely resemble the team everyone expected at the start of the season.

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Chiefs rally past Buffalo 42-36 in OT in wild playoff game

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Chiefs rally past Buffalo 42-36 in OT in wild playoff game

KANSAS CITY, Mo. — Patrick Mahomes found Travis Kelce in the corner of the end zone early in overtime, and the Kansas City Chiefs rallied to beat the Buffalo Bills 42-36 on Sunday night in a sizzling finish to a wild divisional-round weekend.

The lead changed hands three times in the final two minutes of regulation before Harrison Butker, who earlier missed a field goal and extra point, drilled a 49-yarder for Kansas City as time expired to force overtime.

The Chiefs won the coin toss, marched swiftly downfield against the NFL’s top-ranked but exhausted defense, and right into their fourth straight AFC title game. They’ll play the Bengals next Sunday night for a spot in the Super Bowl.

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