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US FDA panel backs first-of-a-kind COVID-19 pill from Merck

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A panel of US health advisers on Tuesday narrowly backed the benefits of a closely watched COVID-19 pill from Merck, setting the stage for a likely authorization of the first drug that Americans could take at home to treat the virus.

A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.

The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.

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The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn't be used in vaccinated patients, who weren't part of the study and haven't been shown to benefit from the medication.

The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end.

The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and US officials brace for the arrival of the new omicron variant. It is already authorized for emergency use.

Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus.

But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans.

“With no data saying it works with new variants I really think we need to be careful about saying that this is the way to go,” said Dr. David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug.

The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier.

Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. That effect was significantly less than the 50 percent reduction it first announced based on incomplete results.

That smaller-than-expected benefit amplified experts' concerns about the drug's toxicity for human fetuses.

FDA scientists told the panelists earlier Tuesday that company studies in rats showed the drug caused toxicity and birth defects when given at very high doses. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”

FDA is weighing a blanket restriction against any use in pregnant women or allowing it in rare cases. Some panelists said the option should be left open for pregnant mothers who have high-risk COVID-19 and may have few other treatment options.

Dr. Janet Cragan, who backed the drug, said that even with tight restrictions some pregnant women would inevitably take the drug.

“I don’t think you can ethically tell a woman with COVID-19 that she can’t have the drug if she’s decided that’s what she needs,” a panel member and staffer with the Centers for Disease Control and Prevention. “I think the final decision has to come down to the individual woman and her provider.”

Merck's drug uses a novel approach to fight COVID-19: It inserts tiny errors into the coronavirus’ genetic code to stop it from reproducing. That genetic effect has raised concerns that the drug could spur more virulent strains of the virus. But FDA regulators said Tuesday that risk is theoretical and seems unlikely.

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, rival drugmaker Pfizer is close behind with its own pill under review.

Pfizer’s drug is part of a decades-old family of antiviral pills known as protease inhibitors, a standard treatment for HIV and hepatitis C. They work differently than Merck’s pill and haven’t been linked to the kind of mutation concerns raised with Merck’s drug.

Pfizer said this week that its drug shouldn’t be affected by the omicron variant’s mutations.

The US government has agreed to purchase 10 million treatment courses of Pfizer’s drug, if it’s authorized. That’s more than three times the government’s purchase agreement with Merck for 3.1 million courses of molnupiravir.

Both drugs require patients to take multiple pills, twice a day for five days.

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Dubai’s Emirates to restart US flights after suspensions over 5G safety concerns

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UAE-based long-haul carrier Emirates said Thursday it would resume its Boeing 777 flights to the US amid an ongoing dispute over the rollout of new 5G services there.

Emirates said its Boeing 777 service to Chicago, Dallas Fort Worth, Miami, Newark, Orlando and Seattle would resume on January 21.

Flights to Boston, Houston and San Francisco, which saw Emirates deploy its Airbus A380 jumbo jet, will resume Boeing 777 flights on January 22.

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Tim Clark, Emirates president, apologized in a statement but warned that American officials had come up with only a “temporary reprieve” for the situation.

“A long-term resolution would be required,” he said.

Major international airlines rushed to rejig or cancel flights to the United States ahead of a 5G wireless rollout on Wednesday that has triggered safety concerns, despite two wireless carriers saying they will delay parts of the deployment.

The Federal Aviation Administration (FAA) had warned that potential 5G interference could affect height readings that play a key role in bad-weather landings on some jets and airlines say the Boeing 777 is among models initially in the spotlight.

Despite an announcement by AT&T and Verizon that they would pause the 5G rollout near airports, several airlines still cancelled flights or switched aircraft models.

Late Tuesday, the FAA began updating its guidance on which airports and aircraft models would be affected, in a move expected to dramatically lessen the impact of the nearly 1,500 notices of 5G restrictions issued by the regulator.

The 777 last year was the second-most used widebody plane on flights to and from US airports with around 210,000 flights, behind only the 767, according to data from FlightRadar24.

Industry sources revealed Boeing had issued technical advisories noting potential interference, but that flight restrictions were in the hands of the FAA, which has for now limited operations at key airports unless airlines qualify for special approvals.

Radio altimeters give precise readings of the height above the ground on approach and help with automated landings, as well as verifying the jet has landed before allowing reverse thrust.

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Nine-member ‘gang’ guilty of money laundering in UAE referred court

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Authorities in the United Arab Emirates have rounded up nine suspects who have been found guilty of laundering funds collected from “theft and fraud operations,” according to a report from official UAE state media WAM.

The UAE Public Prosecution reportedly ordered the defendants to appear in court after the Sharjah Public Prosecution found them targeting workers through an elaborate scheme.

In a statement issued on Wednesday by the Public Prosecution, it said that the “gang of nine suspects” used to issue SIM cards, open bank accounts and obtain ATM cards all under workers’ names.

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The group reportedly ran and managed these accounts through online banking applications, defrauding victims by calling them feigning the identities of bank employees who wanted to update their data or offer the chance to win a monetary prize.

The ruse allowed the nine members to obtain the necessary information, transfer money to other bank accounts they had operated for this purpose, withdraw cash, and then deposit it into accounts belonging to them abroad.

Investigations also revealed that the group of nine forged bank seals.

The Public Prosecution declared in the original statement carried by WAM that it has requested the court to apply the maximum penalty against the accused, in accordance with the provisions of the Federal Decree No. 20 of 2018 on Anti-Money Laundering and Countering the Financing of Terrorism.

This law stipulates that a temporary imprisonment and a fine of no less than AED 300,000 ($81,600) and no more than AED 10,000,000 ($2.7 million) be charged to the perpetrators of the crime.

The Public Prosecution confirmed in the statement that necessary legal actions have been taken against the culprits and urged the public to be “cautious and not to cooperate or respond to fraudsters.”

According to a Bloomberg report, the UAE is at “increased risk of being placed on a global watchdog’s list of countries” subject to more oversight for shortcomings in combating money laundering and terrorist financing, even after a recent government push to stamp out illicit transactions.

The Central Bank of UAE established a dedicated department in August 2020 to handle all Anti-Money Laundering and Combatting the Financing of Terrorism matters (AML/CFT), which the Banking Supervision Department handled previously.

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North Korea hints at restarting nuclear, ICBM tests, defying repeated US warnings

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Accusing the United States of hostility and threats, North Korea on Thursday said it will consider restarting “all temporally-suspended activities” it had paused during its diplomacy with the Trump administration, in an apparent threat to resume testing of nuclear explosives and long-range missiles.

North Korea’s official Korean Central News Agency said leader Kim Jong Un presided over a Politburo meeting of the ruling Workers’ Party where officials set policy goals for “immediately bolstering” the North’s military capabilities to counter the Americans’ “hostile moves.”

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Officials gave instructions to “reconsider in an overall scale the trust-building measures that we took on our own initiative … and to promptly examine the issue of restarting all temporally-suspended activities,” the KCNA said.

The North’s Foreign Ministry had already warned of stronger and more explicit action after the Biden administration last week imposed fresh sanctions over the North’s continued missile testing activity. The latest North Korean threat came as the UN Security Council scheduled a closed-door meeting for Thursday to discuss North Korea and non-proliferation matters.

The North has been ramping up its weapons demonstrations recently, including four rounds of missile launches just this month, amid a prolonged freeze in nuclear diplomacy with the United States.

Experts say Kim is reviving Pyongyang’s old playbook of brinkmanship to extract concessions from Washington and neighbors as he grapples with a decaying economy crippled by the pandemic, mismanagement, and US-led sanctions over his nuclear ambitions.

Kim announced a unilateral suspension of his nuclear and intercontinental ballistic missile tests in 2018 as he initiated diplomacy with then-President Donald Trump in an attempt to leverage his nukes for badly needed economic benefits.

Their summitry came after a provocative run in North Korean nuclear and intercontinental range ballistic missile testing in 2017 that demonstrated Kim’s pursuit of an arsenal that can viably target the American homeland and resulted in him exchanging threats of nuclear annihilation with Trump.

But negotiations have stalled since the collapse of their second summit in 2019, when the Americans rejected North Korea’s demand for major sanctions relief in exchange for a partial surrender of its nuclear capabilities.

At the end of that year, Kim vowed to further bolster his nuclear arsenal in face of “gangster-like” US threats and pressure and declared a “frontal breakthrough” against sanctions while urging his people to stay resilient in a struggle for economic self-reliance.

He then said the North was no longer obligated to maintain its suspension on nuclear and ICBM tests, which Trump touted as a major foreign policy achievement.

However, the pandemic thwarted many of Kim’s economic goals as the North imposed a lockdown and halted most of its trade with China, its major ally and economic lifeline.

North Korea appeared this month to have resumed railroad freight traffic with China that had been suspended for two years.

North Korea conducted its sixth and last test of a nuclear explosive device in September 2017 and its last launch of an ICBM was in November that year.

Some experts say that the North could dramatically raise the ante in weapons demonstrations after the end of February’s Winter Olympics in Beijing. They say Pyongyang’s leadership likely feels it would take a dramatic provocation to move the needle with the Biden administration, which has offered open-ended talks but showed no willingness to ease sanctions unless Kim takes real steps to wind down his nuclear and missile program.

“The present US administration persists in maneuvers to deprive the DPRK of its right to self-defense. All the facts clearly prove once again that the hostile policy towards the DPRK will exist in the future, too as long as there is the hostile entity of US imperialism,” the KCNA said in its report about the Politburo meeting, using an abbreviation of North Korea’s official name, the Democratic People’s Republic of Korea.

It said the Politburo members unanimously recognized the need for North Korea to be prepared for a long-term confrontation with the United States and called for practical measures to “more reliably and effectively increase our physical strength for defending dignity, sovereign rights and interests of our state.”

Kim in recent years had showcased some new weapons he may wish to test, including what appeared to be North Korea’s largest-ever ICBM that was rolled out during a military parade in October 2020.

He also issued an ambitious wish list of sophisticated weaponry early last year while setting a five-year plan to develop military forces, which included hypersonic missiles, solid-fuel ICBMs, spy satellites and submarine-launched nuclear missiles.

If the North does stage another nuclear test, it may use that event to claim it acquired an ability to build a nuclear warhead small enough to fit on a purported hypersonic missile it tested twice so far this year, experts say.

Last week, the US Treasury Department imposed sanctions on five North Koreans over their roles in obtaining equipment and technology for the North’s missile programs, in its response to North Korea’s earlier tests this month.

The State Department ordered sanctions against another North Korean, a Russian man and a Russian company for their broader support of North Korea’s weapons of mass destruction activities. The Biden administration also said it would pursue additional UN sanctions over the North’s continued tests.

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