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FDA panel narrowly backs COVID-19 pill from Merck – Business News – Castanet.net

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A panel of U.S. 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 it should not be used by pregnant women and called on FDA to recommend extra precautions, including pregnancy tests for women before using the drug.

The group’s vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including those with conditions like obesity, asthma and old age.

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

FDA authorization for the drug, molnupiravir, could be a major step in treating the virus. It would give doctors the first drug they could prescribe for patients to take on their own, easing the burden on hospitals and helping to curb deaths.

The pill is already authorized in the U.K.

THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

WASHINGTON (AP) — Government health advisers on Tuesday weighed the benefits and risks of a closely watched drug from Merck that could soon become the first U.S.-authorized pill for patients to take at home to treat COVID-19.

The Food and Drug Administration asked 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. A vote was expected Tuesday afternoon. The panel’s recommendations aren’t binding but often guide FDA decisions.

The meeting comes as U.S. infections are rising again and health authorities worldwide size up the threat posed by the new omicron variant.

If authorized, Merck’s pill would be the first that doctors could prescribe for patients to take on their own to ease symptoms and speed recovery, a major step toward reducing hospital caseloads and deaths. The drug, molnupiravir, is already authorized for emergency use in the U.K.

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

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% reduction it first announced based on incomplete results.

FDA scientists said Tuesday the reasons for the difference were unclear, but appeared to be due to higher-than-expected hospitalizations among patients taking the drug during the second half of the study. Molnupiravir’s effectiveness is a key consideration as panel members weigh whether to recommend the drug and for whom.

Another question is whether pregnant women or women of child-bearing age should avoid the drug.

FDA scientists said Tuesday that company studies in rats showed the drug caused toxicity and birth defects in the skeleton, eyes and kidneys. Taken together, FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”

Regulators said they are considering barring molnupiravir’s use during pregnancy or warning against it but leaving it as an option in rare cases. The FDA also proposed that doctors verify patients are not pregnant before starting treatment and recommend contraceptives to certain patients.

In its own presentations Tuesday, Merck said it is not recommending the drug be used in women who are pregnant or lactating. But the drugmaker opposed a blanket restriction on prescribing to those patients, arguing there may be certain cases where the drug’s benefit outweighs its risk.

The 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.

Merck scientists said they believe their drug will be effective against the new omicron variant. They said the drug worked against other variants, including the prevailing delta strain.

Panelists are also weighing whether the pills 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.

Merck tested the drug in adults with mild-to-moderate COVID-19 who were considered higher risk due to health problems like obesity, diabetes or heart disease. That’s the same group that currently receives antibody drugs, which help the immune system fight the virus. The FDA has authorized three antibody drugs for COVID-19 but all have to given by IV or injection at hospitals or clinics.

Merck was the first company to submit its COVID-19 pill to the FDA, but a rival drug from Pfizer is close behind and is also 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.

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Apple poised as Peloton's saviour among news the company is pausing equipment production – MobileSyrup

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A recent report from CNBC regarding Peloton’s manufacturing rate helped plummet the company’s stock by 24 percent in a single day.

The media outlet reports the exercise bike manufacturer has temporarily halted production of its fitness products because of a drop in consumer demand.

Internal documents revealed bike productions will pause in February and March. Production of Bike+ was halted back in December and won’t resume until June. The Tread treadmill won’t start manufacturing again for six weeks until February. Further, production of Tread+ was previously halted and likely won’t resume this year.

This fueled ongoing rumours surrounding the fitness company’s production problems, with Insider reporting Peloton will lay off 41 percent of its staff in its sales and marketing departments.

Once noted as the darling of connected exercise equipment, the company is now struggling. CNBC says that Peloton overestimated how many people would buy its products after a jump in sales tied to at-home workouts during the pandemic.

Now experts are saying the only way to save the Peloton is if tech giant Apple purchases it. Financial advice publication, The Motley Fool, reports Apple has the cash to spare and “wants to be a force in health and wellness.” However, the article also notes a possible acquisition would “benefit Peloton far more than it would Apple,” given the fitness company’s smaller “market opportunity.”

Peloton CEO John Foley has denied that production is slowing or halted and says media reports are “incomplete and out of context.”

“Rumors that we are halting all production of bikes and Treads are false,” Foley wrote in a letter of response.

However, he did acknowledge layoffs may soon be on the horizon.

“We now need to evaluate our [organizational] structure and size of our team, with the utmost care and compassion. And we are still in the process of considering all options as part of our efforts to make our business more flexible,” he wrote.

Image credit: Shutterstock

Sources: CNBC, Insider, The Motley Fool

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Latest research says combination of throat and nose swabs provides better COVID-19 rapid test results: Nova Scotia Health – CTV News Atlantic

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In a Canadian first, Nova Scotia researchers say COVID-19 rapid tests that include both throat and nose swabs provide greater accuracy in detecting the virus.

Up until now, the instructions provided by the manufacture has been for nasal swab only.

Now, based on research led by Nova Scotia Health’s microbiology team, public health is recommending Nova Scotians using rapid tests swab both their throat and nose when collecting their sample.

In a release Friday, Nova Scotia Health said its working to update the current testing instructions that people receive when they pick up a rapid test.

The research was prompted by public discussion theorizing that a combined sample may produce more accurate results.

Speaking to CTV Thursday, Dr. Todd Hatchette, the chief of the province’s Division of Microbiology, Department of Pathology and Laboratory Medicine, said researchers found using a single swab on a person’s throat first, and then in both nostrils is more effective at detecting Omicron than doing either site alone.

“When we tested just over 1,500 people, we found that either the nose or the throat both detected about 60 per cent of people, but if you did a combined nose / throat, it detected over 82 per cent of people,” said Hatchette.

The research started about a week ago. Officials at the microbiology lab worked with volunteers at the Halifax Convention Centre testing site to collect the data.

In Friday’s release, Nova Scotia Health says collaboration with volunteer-based community rapid testing sites was key to the project’s success and allowed the project to rapidly answer a question that many jurisdictions across the country have been asking.

The investigation compared results of a common rapid take-home test using three sample sites: nasal swab; throat swab and; combined nasal/throat, the release said. All results were confirmed with PCR testing. Compared to PCR test results, samples from nasal or throat swabs each detected 64.5 per cent of cases; however, combining the nose and throat swabs increased sensitivity to 88.7 per cent.

This research project has been submitted for publication.

Dr. Theresa Tam, Canada’s chief public health officer, speaking Friday from Ottawa, welcomed the Nova Scotia swab study.

“I’ve asked our laboratory network, our laboratory experts, to take that into account and see whether we can provide some sort of guidance,” Tam said. “But, of course, I think we’ve been discovering that the Omicron variant may be behaving a bit differently to the previous variants, so this approach, this swabbing, might be useful.”

One thing to note, public health is advising that if only one location of the sample is being used, it should be the nasal swab, as the throat swab alone is not as effective as the nasal swab.

Nova Scotia is the first to report research results supporting a combined throat/nose collection method for self-administered rapid antigen tests.

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Gold price next week: a breakout or a sideways trap? All eyes on hawkish Fed and stocks volatility – analysts – Kitco NEWS

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(Kitco News) The gold market surprised with a breakout above $1,830 an ounce this week. And analysts say next week will be pivotal in whether gold breaks out or gets stuck in the sideways price action again.

In an unexpected move, the precious metal surged to two-month highs this week, with investors flocking to safe havens as volatility rocked the equity markets ahead of the Federal Reserve meeting next week.

With stocks and the crypto space selling off, money has to go somewhere, RJO Futures senior market strategist Frank Cholly told Kitco News.

“Gold rallied this week due to all the weakness in the equity market. Bitcoin is down pretty good too,” Cholly said. “We have a bottom in gold. The question is, are we going to go lower and stay sideways or climb towards $1,900. The precious metal needs another close above $1,830. It’s critical to hold that level before a move above $1,850.”

The move in gold did surprise some analysts because of how swift it was, said Gainesville Coins precious metals expert Everett Millman.

“The gold market has been going sideways for several months. To see a breakout in either direction was a bit surprising. Coming into this week, sentiment in the gold market was very negative. Many big banks were projecting the gold price to go down. This ended up playing in gold’s favor as negative sentiment set us up for a reversion in another direction,” Millman said.

Also, rising oil prices and strong retail demand have contributed to higher price levels in gold. “Higher oil does make it more expensive to get gold out of the ground. We could see constraints in the gold supply being mined. Plus, the real demand for gold is still strong. The U.S. Mint saw 12-year highs in gold sales, while the Perth Mint saw 10-year highs. Average retail investors are still buying gold at the fastest pace in ten years,” Millman added.

All eyes are on how markets will react to the Federal Reserve monetary policy meeting, scheduled for Wednesday. Cholly estimates to see a steeper sell-off in U.S. equities as the central bank maintains the same level of hawkishness.

“We could go through a more meaningful correction in equities. We’ll have more evidence of the Fed’s direction. And the stock market likes to throw tantrums to get the Fed’s attention. Next week, gold’s strength will hinge on equities moving lower and reallocation of money into precious metals. Silver may even become the leader as we move forward,” Cholly pointed out.

If gold does break above $1,850, it opens the door for $1,870-80 and eventually $1,900, he added.

Fed in focus

The Fed meeting, which will be followed by the central bank Chair Jerome Powell’s press conference, is the biggest macro event next week.

Analysts expect to get more hawkish clues in terms of the first rate hike in March and more clarity around the potential balance sheet runoff. Currently, markets are pricing in four rate hikes in 2022.

“With the Omicron wave now past its peak nationally, there is little to hold the Fed back, particularly if next week brings news of a further acceleration in wage growth,” said Capital Economics chief North America economist Paul Ashworth. “A dissenting vote, to raise rates immediately, from one of the hawkish regional Fed Presidents – who will be voting as part of the annual rotation – could also add fuel to the recent bond market sell-off.”



There is also a risk that the Fed could get even more hawkish by announcing the completion of the tapering process immediately, said ING chief international economist James Knightley.

“The Federal Reserve meeting will be the main focus, and we strongly suspect that we could see the announcement of the ending of QE asset purchases brought forward from the mid-March end-point currently signaled, to an immediate cessation, “Knightley wrote. “In an environment where the economy has fully recovered the lost output from the pandemic, where unemployment is back below 4% and where inflation is at near 40-year highs, it seems strange to say the least for them to continue stimulating the economy.”

Other key data releases to keep an eye on will be Tuesday’s CB consumer confidence, Thursday’s Q4 GDP number, jobless claims and durable goods orders, as well as Friday’s PCE price index.

“We expect to learn that fourth-quarter GDP growth was a slightly disappointing 4.0% annualized. But markets may focus more on the Employment Cost Index (ECI). Private wage growth hit 4.6% y/y in the third quarter and could have climbed as high 5% in the fourth, which would make a March rate hike a near-certainty,” Ashworth noted.

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